New ads urge minorities to participate in coronavirus vaccine trials

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New ads urge minorities to participate in coronavirus vaccine trials
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As coronavirus vaccine trials struggle to get minority participation, a group formed by the National Institute of Allergy and Infectious Diseases has unveiled an ad campaign urging Black and Latino people to get involved.

The campaign, which includes television commercials and print ads, began to roll out earlier this week.

"This pandemic is not red. This pandemic is not blue. This pandemic is black, is brown, is white. It hits all colors and creeds," a voice-over on one ad says. "But even when things look bleak, we know that someone is full of hope and strength and wants to take action."
The ad features several people of different ethnicities. A second ad shared with NBC News includes a Black bus driver saying he's an essential worker and a Black restaurant worker saying he's a father. "That's why I volunteered," both men say.
The commercials, which were first reported by CNN, were developed by the Covid-19 Prevention Network, which, according to its website, was formed as a response to the pandemic and will help "conduct Phase 3 efficacy trials for COVID-19 vaccines and monoclonal antibodies."
Dr. Larry Corey, a virologist at Fred Hutchinson Cancer Research Center who leads the network, said it is crucial that the vaccine trials include minority volunteers.



“Our country and our global partners need vaccines against SARS-CoV-2 that are demonstrated to be safe and effective for everyone; so, it’s imperative that these vaccine trials are allowed to be conducted at the highest scientific standards and are inclusive of the people who have been most impacted by COVID-19,” he said in a statement Thursday to NBC News.

Corey said he believes the ad campaign "represents the most important voices in this fight" including essential workers, grandparents and food industry workers. "All of whom are feeling the impact of the pandemic every day and want to help find an answer to this ongoing restriction in our schools, travel and everyday life," he said.
Norbi Zylberberg, the founder of the advertising agency Socialisssima — which created the ads along with Sam Bonds Creative — said he hopes the ads give people a sense of hope.
The ads are “acknowledging what’s happening but giving people the choice to help, to roll up their sleeves," Zylberberg told NBC News in a phone interview Thursday. "But they're also explaining that the sooner we do that, the sooner we can go back to some normalcy.”
The television ads will run in both English and Spanish and will air on national networks as well as BET, the Oprah Winfrey Network, TV One, Telemundo and Univision.
Dr. Francis Collins, director of the National Institutes of Health, said at a Senate vaccine panel Wednesday that because the African American and Latino communities are the hardest hit by the coronavirus pandemic, it's important to know what benefits a vaccine will have on those groups.
"It’s without a doubt that there are also concerns in many of those communities about whether this is something they should trust to be in their best interest. There’s skepticism, there’s distrust," he said.
But "if we don’t succeed in having diversity in the participants in these trials, I think that takes scientifically away from the value of what we’re trying to learn," Collins added.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told NBC News last week that without minority participation in the clinical trials, "you will not have definitively proven that the vaccine is safe and effective in them."
As of Sept. 4, roughly 26% of Moderna's participants were from "diverse communities," according to the website. Data shows that 10% of Moderna's new enrollments last week were Black and 16% were Hispanic or Latino, compared to 67% who were white. Pfizer's data shows that among its U.S. participants, 8% were Black and 11% were Latino.

The struggle to get minority involvement in the trials is layered. Some people are concerned that the White House is pushing the Food and Drug Administration to quickly approve a vaccine. Although Fauci had previously said that he believed a vaccine would likely be developed by the end of the year, DUMB ASS Donald Trump said during an August speech at the Republican National Convention that a vaccine was being produced "in record time" and promised to have a "safe and effective" vaccine this year.

Other concerns about the trials center around the infamous Tuskegee Syphilis Study, an experiment where Black men in Alabama were deliberately left untreated for syphilis and denied penicillin as treatment so government researchers could study the disease's effects. The study ran from 1932 to 1972.
While speaking with NBC News, Fauci said to try and calm minority groups who may be concerned about participating in the trials, "We need to make sure that we prove beyond a doubt that what we're doing is safe and effective."


Scientists Conduct Consent-Free Experiments Disproportionately on Blacks, Study Says
The Tuskegee Experiment gave Black people a good reason to distrust what's happening.
Written By Nigel Roberts
Posted October 2, 2018

Given the African-American experience with the infamous Tuskegee experiment, it’s worrisome that the risks associated with consent-free experiments are not fairly spread out by race.
See Also: Blacks Underrepresented In ‘Life And Death’ Clinical Research, Study Finds
A study released on Monday found that African Americans are enrolled in clinical trials that don’t require patient consent at a disproportionately high rate, Stat News reported.
This involves administering experimental emergency medical procedures and drugs on patients who often can’t give consent because they’re unable to respond to questions. The Food and Drug Administration permits researchers to conduct these treatments under certain guidelines.

The study, published in Health Affairs, found that 29 percent of the patients involved in these experiments are Black, although African Americans represent about 13 percent of the population.


This stands in contrast to multiple studies that found African-Americans are underrepresented in consensual medical research. One study published in June, found that doctors have long used inaccurate guidelines to determine cardiovascular risks, which was particularly the case with at-risk African-Americans patients. A significant part of the problem with the guidelines was that Blacks were underrepresented in the patient sample used to create the guidelines.
News about consent-free experiments comes against the backdrop of government experiments, from 1932 to 1972, on African-American sharecroppers in Tuskegee, Alabama. Researchers deceived Black men about receiving treatment for syphilis, which actually went untreated. The experiments have contributed to widespread distrust in the African-American community of medical experiments—especially without consent.
The new study also revealed that many researchers who conduct consent-free experiments use a loophole to avoid publishing certain demographic data about the people they test. Government reporting regulations don’t specify which data they must reveal. This only adds to the lack of transparency and distrust.
 

xxxbishopxxx

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I keep wondering how the anti-vaxxers trump supporters are dealing with this. This is one time they can legit bring their views to the forefront, but they seem kind of quite (at least to me).

Then you got the BIll Gate conspiracy dudes out there that don't mention that the current republican president is openingly pushing for a national roll-out for a vaccination that will be days old when released into the general public. Yet will be quick to tell you not to wear a simple mask and try to be safe through general caution.
 

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Once hailed as the world’s best hope, the Oxford/AstraZeneca vaccine trial hits a bump in the road—and that might be good news.

With pandemic death rates in the U.S. and Britain ratcheting upward, Gilbert’s forecast soothed panicky citizens who had been told that it typically takes years to develop a successful vaccine. The New York Times wrote that Oxford had leapt ahead of the competition and was “sprinting fastest” to the finish line. Within weeks, Oxford had partnered with British pharmaceutical giant AstraZeneca and the two were inking deals around the world to manufacture and distribute hundreds of millions of doses. The vaccine became one of the world’s best hopes: By late August, with Phase III trials to determine safety and efficacy ongoing, the world had ordered more of the Oxford candidate than any other, at least 2.94 billion doses.


Now, Gilbert’s, and the world’s, hopes are coming back down to earth, with the news that AstraZeneca paused Phase III trials after one participant in Britain showed symptoms consistent with transverse myelitis, a rare neurological disease caused by inflammation of the spinal cord. Obstacles like this one are not unexpected in vaccine development, experts say. The fact that AstraZeneca is pausing trials to investigate, they point out, is a good thing—a signal that that system is working as it should, that drug companies are taking safety seriously, that there are some scientific norms that politics hasn’t trampled.

But the interruption is also a reminder that no amount of hype—from the endless media headlines, from politicians on Twitter, from the vaccine scientists themselves—is going to save the world from the deadliest pathogen in a century. This week’s news is a cautionary note for those who think a magic bullet might be around the corner—or who think that it might be worth slashing safety protocols to get one.
 

QueEx

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I keep wondering how the anti-vaxxers trump supporters are dealing with this . . .
Then you got the BIll Gate conspiracy dudes out there that don't mention that the current republican president is openingly pushing for a national roll-out for a vaccination that will be days old when released into the general public.

And I keep wondering how the members of the Republican Party, especially those in the U.S. Senate, continue their unwavering support for this president wannabe Dictator. :confused:
 

QueEx

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Other concerns about the trials center around the infamous Tuskegee Syphilis Study, an experiment where Black men in Alabama were deliberately left untreated for syphilis and denied penicillin as treatment so government researchers could study the disease's effects. The study ran from 1932 to 1972.
While speaking with NBC News, Fauci said to try and calm minority groups who may be concerned about participating in the trials, "We need to make sure that we prove beyond a doubt that what we're doing is safe and effective."
Well, my brothers, looks like WE are approaching that point.






To Trust or Not to Trust ? ? ?

That is OUR question . . .

.
 

QueEx

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Pfizer and BioNTech say final analysis shows coronavirus vaccine is 95% effective with no safety concerns
By Maggie Fox and Amanda Sealy, CNN

Updated 7:30 AM ET, Wed November 18, 2020


(CNN) A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday.

The company counted 170 cases of coronavirus infection among volunteers who took part in the trial.
- It said 162 infections were in people who got placebo, or plain saline shots,
- while eight cases were in participants who got the actual vaccine.
That works out to an efficacy of 95%, Pfizer said.

The data show Pfizer's initial claim of a better than 90% efficacy -- a claim that stunned and pleased health officials and vaccine developers last week -- holds up.

"Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%," Pfizer and its German partner BioNTech said in a joint statement.

- "There were 10 severe cases of Covid-19 observed in the trial,
- with nine of the cases occurring in the placebo group;
- and one in the BNT162b2 vaccinated group." (BNT162b2 is the experimental name for the vaccine)."


An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said.

Pfizer said it will seek US Food and Drug Administration emergency use authorization "within days."

"These data also will be submitted to other regulatory agencies around the world," Pfizer said. They plan to publish the data in a peer-reviewed scientific journal, as well.




The Phase 3 clinical trial of the vaccine began on July 27. Pfizer said of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo.

The FDA said it wanted at least two months of safety tracking on volunteers after they got their second shots.


The companies also said they have tried to recruit a diverse pool of volunteers, to match more closely the groups most severely affected by the pandemic.


"Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age," Pfizer said.

The 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina will continue to collect information about efficacy and safety for two more years.


1.3 billion doses expected in 2021
"Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021," they said.


 

Mrfreddygoodbud

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BGOL Investor
if you a moorish american, and thats all dark skin people indigenous to America and America is A WHOLE FUCKIN CONTINENT.

folks talkin about the tuskeegee experiment what they are not talkin about is...

the only reason they stopped is becauae they got caught...

and till this day we dont know the wide spread damage that has caused us,

literally committing medical crime on us... and nobody paid a price for it..

you want me to trust a fuckin system that allowed this shit to happen,

and only alledgedly stopped because they got caught... I do we even KNOW it fuckin stopped...

Well it stopped with me because I dont fuck wiht doctors of death and their experimental labs yall call hospitals..

its hospitals if you could afford it to be a hospital... you just got some insurance yo ass just a fuckin lab rat...

these muthafuckas got nerve talkin this shit.. and they aint arrest not ONE soul

for the insane about of medical crimes the medical establishment has inflicted on

my people....

fuck em hard fuck em long
 

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Do U really trust the Bill & Melinda Gates nanoparticles vaccines that can track your life history? The Lucifer vaccine 666. Read up before getting injected with this overhyped shot!
 

QueEx

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CORONAVIRUS

Who Decides When Vaccine Studies Are Done? Internal Documents Show Fauci Plays a Key Role.
Dr. Anthony Fauci will see data from government-funded vaccine trials before the FDA does. One caveat: Pfizer’s study, which is ahead of the others, isn’t included in his purview.



ProPublica
by Isaac Arnsdorf,
Caroline Chen and
Ryan Gabrielson
Oct. 16, 2020



Dr. Anthony Fauci.

Dr. Anthony Fauci in Washington this fall. (Jennings Graeme/Sipa via AP Images)


ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.


Dr. Anthony Fauci, the nation’s top infectious disease official, will oversee most of the ongoing COVID-19 vaccine trials in the U.S., but not that of the current front-runner made by Pfizer, documents obtained by ProPublica show.

According to a draft charter spelling out how most of the advanced COVID-19 vaccine trials will be monitored, Fauci is the “designated senior representative” of the U.S. government who will be part of the first look at the results. That puts Fauci in the room with the companies — including Moderna, Johnson & Johnson and AstraZeneca — in deciding whether the vaccines are ready to seek approval from the Food and Drug Administration.

Fauci’s role, which has not been previously reported and was confirmed for ProPublica by the National Institutes of Health, could offer some reassurance in the face of widespread concerns that President Donald Trump wants to rush through an unproven vaccine. As Sen. Kamala Harris, the Democratic nominee for vice president, put it at last week’s debate, “If the public health professionals, if Dr. Fauci, if the doctors tell us that we should take it, I’ll be the first in line to take it.”


But there’s a big caveat. Fauci doesn’t have the same hands-on role for the vaccine that seems poised to show results soonest: Pfizer’s. That’s because Pfizer opted not to accept government funding and participate in the federal program to develop a coronavirus vaccine, known as Operation Warp Speed. (The government did make an almost $2 billion deal with Pfizer to preorder up to 600 million doses of the company’s vaccine, but it isn’t contributing money to the vaccine’s development like it is for other companies.)

“(We) offered opportunities for collaboration with Pfizer,” said a spokesperson for the National Institutes of Allergy and Infectious Diseases, a branch of the NIH. “Pfizer chose to conduct their Phase 3 study without Operation Warp Speed or NIH support.”

Pfizer’s CEO, Albert Bourla, said Friday that the earliest his company would be ready to apply for authorization would be the third week of November. While Pfizer might know by the end of October if its vaccine is effective, it would need additional time to gather sufficient safety data to present to the FDA, Bourla said in an open letter on the company’s website.

Fauci’s role in overseeing the companies that are participating in Operation Warp Speed arises from a unique arrangement that the government set up to monitor the trials. Typically, clinical trials set up their own independent panels of scientists, known as a data safety monitoring board or DSMB, to watch out for safety concerns or early signs of success. But all of the vaccine trials in Operation Warp Speed are sharing a common DSMB whose members were selected by Fauci’s agency, the NIAID. They’re also sharing a network of clinical trial sites where some volunteers are recruited for the studies.


A DSMB is responsible for making recommendations such as halting the trial if there is a safety concern or letting the manufacturer know that there’s enough evidence to submit an application to the FDA. Ordinarily, a DSMB’s recommendation goes to the company running the trial. In this case, the U.S. government — which gets two representatives, one from the NIAID and one from the Biomedical Advanced Research and Development Authority — will also have a seat at the table in deciding what to do next.

“Once the DSMB makes a decision, the DSMB provides the recommendation to not only the study sponsor but also to the” U.S. government, whose “designated senior representative” is Fauci, the NIAID confirmed in an email. Fauci declined to be interviewed.

That’s not the same as saying Fauci has the last word. The company and the government are supposed to reach a consensus, the agency said. But if they can’t all agree, the ultimate decision belongs with the company.

Still, it would be an improbably brazen move for a company to move ahead over Fauci’s objection, given his public stature, experts said. “These are the most important trials in medical history, this is the ultimate fishbowl,” said Dr. Eric Topol, director of the Scripps Research Translational Institute. “I don’t think any sponsor would dare defy the DSMB’s recommendation.”

While the mechanics of a DSMB may be unfamiliar to most members of the public, people probably know and trust Fauci, according to Amy Pisani, executive director of the national nonprofit organization Vaccinate Your Family. “(He’s) the sweetheart of the nation right now,” Pisani said. “I do think people have faith in Anthony Fauci.”

“Having Fauci with oversight is terrific,” Topol added. “The more people who are experts looking at it, the better. You can’t be careful enough.”

Other members of the DSMB for the COVID-19 vaccines, though not as well known as Fauci, are also widely respected in their fields. DSMB members are typically kept confidential to shield them from outside influence, but ProPublica has been able to identify a few members. The charter obtained by ProPublica described the group, which has about a dozen members, as having expertise in “biostatistics, clinical trials, infectious diseases, vaccine development and ethics.”



The panel’s chair is Dr. Richard Whitley, a professor of pediatrics, microbiology, medicine and neurosurgery at the University of Alabama at Birmingham. His role became public when the university announced it, though the webpage was later taken down.

His leadership provides another level of comfort in the trustworthiness of the trials to those who know him. “He is not only famously bright but he is famously independent and outspoken,” said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt Medicine. “He’ll look at the data and tell you exactly what he thinks.”

Whitley declined to comment.

Susan Ellenberg, professor of biostatistics at the University of Pennsylvania and a former director at the FDA, told ProPublica in an interview that many people, including herself, were worried the NIH might be “pushed by the political leadership at HHS to release data” from trials prematurely, which could undermine the integrity of a trial. HHS, the U.S. Department of Health and Human Services, is the NIH’s parent agency. Her concern was that political leaders might not understand scientific arguments to not disrupt the trials when wanting to have data “to be able to move quickly in an urgent situation,” she said.

At the time of the interview, Ellenberg had not identified herself as a member of the NIH’s DSMB, but later acknowledged that she was a member.

Dr. Malegapuru William Makgoba, an immunologist based in South Africa, is one of a few international members of the DSMB. Makgoba is well known for his work on public health initiatives around HIV/AIDS, including the South African AIDS Vaccine Initiative. Makgoba confirmed his role on the DSMB but declined to comment further.

The common DSMB appears to be unprecedented, if only because there have not previously been multiple vaccines in development for the same disease at the same time. Experts said the arrangement offers benefits such as bolstering the evidence available to show that any one shot is safe and effective.

Standardizing trial measurements should make the vaccines easier to compare head to head, which may be useful for knowing whether one is better or worse than another in certain subgroups, such as the elderly or people with compromised immune systems, according to Vanderbilt’s Schaffner.

“To me, it’s better for public health to have a fairly common assessment,” said Dr. Gregory Glenn, president of research and development at Novavax, which has received $1.6 billion from Operation Warp Speed and hopes to begin its Phase 3 trial in the U.S. this month as part of the NIH’s clinical trial network.

There may also be some benefits from a safety perspective.

If a potential safety issue appears in one trial, having a common data safety monitoring board for multiple trials means that the board knows to look out for that same issue across all the trials, said Dr. Tal Zaks, chief medical officer of Moderna. “When AstraZeneca had an adverse side effect, we have a DSMB looking at our trial — the fact that it’s the same DSMB means that there’s not one DSMB that has to go educate another DSMB,” Zaks said. (ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.)

AstraZeneca’s trial has been put on hold in the U.S. while the company and the FDA investigates what happened with a participant who had a bad reaction. It’s not yet clear whether the reaction was due to the vaccine or unrelated.

“AstraZeneca is committed to working with governments and key partners to ensure we develop and gain regulatory approval for an effective vaccine as quickly as possible,” the company said in a statement.



AstraZeneca added that another benefit of joining the government’s consortium was that its large network of trial sites can help reach minority communities that are historically less represented in clinical trials and also more vulnerable to COVID-19.

Pfizer’s decision not to participate means that it and the other companies may miss out on some of these benefits of pooling resources. “It’s at least unfortunate, and not very sporting, as the British would say,” Schaffner said.

At the same time, there could be advantages to Pfizer’s going solo. “One of the greatest risks to this process is the perception of political influence, and in that regard, having parallel efforts, especially efforts seen as independent of one another and/or independent of perceived sources of political influence, is a good thing,” said Mani Foroohar, an analyst at the investment bank SVB Leerink.

Pfizer declined to comment on its decision not to join the government’s shared DSMB and trial network.

Whether it’s Pfizer or one of the companies participating in Operation Warp Speed, the final say on whether a vaccine is ready for public use belongs to the FDA.

The FDA has promised to present the data to an advisory committee of external experts in a public meeting. A preliminary meeting will be held on Oct. 22 to discuss, generally, the standards the FDA will seek to see before authorizing any vaccine. The agency has also committed to holding advisory committee meetings to review data from individual vaccine candidates.

Between the independent trial safety monitoring boards and the public advisory committee meetings, “any kind of hanky-panky there that people are worried about is going to (go through) multiple checkpoints,” Fauci said in an interviewwith Dr. Howard Bachner on the JAMA Network podcast on Sept. 25. “The big elephant in the room is, is somebody going to try to make a political end run to interfere with the process? … If you look at the standard process of how these things work, I think you can feel comfortable that it is really unlikely that that is going to happen.”


 

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What are the side effects of Pfizer's, Moderna's vaccines?
Your questions answered

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Also: How were volunteers infected? When will Canada get these vaccines?

Emily Chung, Amina Zafar · CBC News · Posted: Nov 17, 2020 3:08 PM ET | Last Updated: November 18


Both Moderna and Pfizer have announced that preliminary results from their Phase 3 clinical trials show their vaccines are more than 90 per cent effective in protecting against the coronavirus infection. (Dado Ruvic/Reuters)


Pfizer/BioNTech and Moderna both announced in November that their vaccine candidates against the novel coronavirus have shown promising results so far in Phase 3 clinical trials. The two vaccines are among several that have been preordered by the Canadian government.

So how close are we to getting the vaccine?
What needs to happen first?
And what kind of vaccine is this anyway?


CBC readers have also written to us with some of their own questions, such as

what are the side effects of these vaccines?
How long does the protection last?

And when can Canadians expect to get access?

Here are the answers.

What did Moderna and Pfizer announce about their vaccine results?
On Nov. 18, Pfizer released updated results of its Phase 3 clinical trials, suggesting the vaccine is 95 per cent effective at preventing COVID-19, a little over a week after releasing interim results showing the vaccine may be 90 per cent effective.​
Moderna announced on Nov. 16 that preliminary data from its ongoing Phase 3 clinical trial shows the vaccine is 94.5 per cent effective at preventing COVID-19 caused by the coronavirus.​
The analyses were both conducted by an independent data monitoring board. Pfizer's updated results looked at 170 infections, while Moderna's looked at 95 infections recorded so far during the trial to see which occurred among those who received the real shot versus those who received a dummy shot or placebo.​
With both vaccines, each participant gets two injections.​

Moderna said of the 95 infections, all but five were in participants who got the placebo. In addition, all 11 severe cases of COVID-19 were among those who had received the placebo. Pfizer said of 170 infections — more than the number required to meet the "primary endpoint" of the study — only eight occurred in the group that got the vaccine, and only one was a severe case.​


What don't we know based on these results? Why might the final results be different?
Moderna's results come partway through the study, and the initial protection rate might change by the time the study ends, the company said. Moderna's analysis looked for cases starting two weeks after the second dose of the vaccine.​
If the shots wear off quickly, the infection rate could go up among those who received them.​
There are also still questions about how effective the vaccines are for older adults and those with chronic conditions, who are at highest risk from the disease. Pfizer did not say how many of the infections occurred in older adults, but it claimed the vaccine was 94 per cent effective among those over 65.​
Dr. Zain Chagla, an infectious diseases specialist at St Joseph's Healthcare in Hamilton, said the clinical trials included adults without major medical issues.​
"They took people that didn't have dementia, didn't have chemotherapy," Chagla said on CBC News Network. "As you start adding those parts in the real-world setting, you may run down some of the efficacy. Now, starting at 95 per cent is pretty good."​
Moderna said 15 of the infections so far occurred in older people, but did not say how many were in the vaccine group or the placebo group. It did say that preliminary analysis suggests a "broadly consistent safety and efficacy profile across all evaluated subgroups." (Vaccines are often less effective in older populations, which is why there are higher-dose flu and shingles vaccines for seniors.)​


Do the vaccines just stop symptoms or prevent infection?
We don't know yet.​
So far, only people with symptoms have been tested in these trials, as that is the "primary endpoint" of the study — the first thing that they look for. That means it's not clear if there are asymptomatic infections and whether vaccinated people can unknowingly spread the disease.​
Moderna says key "secondary endpoints" of its clinical trial are to see if the vaccine:​
  • Prevents severe disease. (The company did say that all 11 of its volunteers who got severe COVID-19 were in the placebo group, suggesting that it does).
    • Prevents infection (including asymptomatic infection).
The Moderna data is not complete, and the final data has not been peer reviewed or published for either study.​

WATCH | Why infectious disease experts are encouraged, cautious about Pfizer vaccine:


Pfizer COVID-19 vaccine data needs reviewing: infectious diseases physician
3 days agoVideo
7:08
Though encouraged by what he knows so far about Pfizer's COVID-19 vaccine, infectious diseases physician Dr. Zain Chagla says there's still a lot of data that needs to be peer reviewed. He also cautions that the vaccine's estimated efficacy rate of 95 per cent may not be maintained outside clinical trials. 7:08
Moderna and Pfizer say they will submit the data to a scientific peer-review publication once they're complete.


How well do the vaccines need to work to be approved?
The U.S. Food and Drug Administration has said a vaccine must be at least 50 per cent effective to be approved, ideally for preventing the disease but possibly for only preventing severe disease.
The World Health Organization recommends that, at minimum, it wants a clear demonstration that the vaccine is effective at least 50 per cent of the time in preventing the disease, preventing severe disease or preventing shedding or transmission. However, it says it prefers vaccines to have at least 70 per cent efficacy across the whole population, with consistent results in the elderly.
WHO also said the vaccine must confer protection for at least six months and ideally at least one year.


What kind of trials were these? How far along were they?
These were Phase 3 clinical trials, the final human trial step before regulatory approval. While Phase 1 and Phase 2 studies are focused mainly on safety, dosing and lab indicators of an immune response, Phase 3 trials answer a key question: are those who get the vaccine protected from the disease compared to those who get a placebo? It could also reveal rarer side effects that aren't observed in smaller Phase 1 and 2 trials.
WATCH | Optimism about Pfizer's COVID-19 vaccine:


Preliminary results encouraging for COVID-19 vaccines: epidemiologist
6 days agoVideo
5:40
Interim analysis suggests COVID-19 vaccines from Pfizer and Moderna will work, but final results, expected later this year, are necessary to confirm, says epidemiologist Dr. Christopher Labos. 5:40
Both trials started on July 27. Pfizer's study enrolled more than 43,000 people in the United States, Argentina, Brazil, Germany, South Africa and Turkey. Moderna's study enrolled 30,000 in the U.S. In both studies, each person gets two shots, 28 days apart. Some get the real vaccine candidate, while the others get a placebo.
The Phase 3 trials will end when:
  • At least half the participants have been tracked for side effects for at least two months.
  • Pfizer records 164 infections and Moderna records 151. Moderna has 56 left to go.
Pfizer said it had met both those requirements as of Nov. 18.



In scathing ruling, judge dismisses Trump campaign's effort to overturn election results in Pennsylvania (msn.com)
 

QueEx

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AstraZeneca Faces More Vaccine Questions After Manufacturing Error


AstraZeneca Plc and the University of Oxford, among the front-runners in the quest to deliver a Covid-19 vaccine, face mounting questions about their trial results after acknowledging a manufacturing error.


While an announcement earlier this week by AstraZeneca and Oxford showed their shot was 70% effective on average in a late-stage study, the scant details released by the U.K. partners have sparked worries about whether regulators would clear it. In a later statement, Oxford said a difference in manufacturing processes led to some participants being given a half dose instead of a full one.


AstraZeneca and Oxford had said their vaccine was 90% effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%. But the head of the U.S. vaccine program known as Operation Warp Speed said the next day that the dose showing the higher level of effectiveness was tested in a younger population, and that the half-dose was given to some people because of an error in the quantity of vaccine put into some vials.
None of this was disclosed in AstraZeneca’s original announcement.


The findings unveiled Monday had fueled optimism that an end to the pandemic is in sight and that multiple vaccines to combat Covid-19 could be ready soon following positive results earlier this month from Pfizer Inc. and Moderna Inc. AstraZeneca and Oxford remain near the front of the pack, although the way they have handled the large trial has rattled scientists and investors.


In its statement, Oxford said that when it was apparent that a lower dose was used, it was discussed with regulators, and an agreement was reached to push ahead with the two regimens. “The methods for measuring the concentration are now established and we can ensure that all batches of vaccine are now equivalent,” according to the university.


A spokesman for Astra said the trials were conducted “to the highest standards” and more analysis is being done to refine the efficacy reading.


Astra shares were little changed Thursday after slumping 6.2% earlier in the week.


“The most likely explanation for the divergent efficacy in its interim analysis is either chance or patient demographics,” Sam Fazeli, a Bloomberg Intelligence analyst, wrote in a note. “Either way, approval based on current data means people will be inoculated with a vaccine the true efficacy of which is unknown.”


The battle against Covid-19 is at a turning point with encouraging vaccine trial findings coming this month. One vaccine from Pfizer and BioNTech SE and another from Moderna Inc. were both about 95% effective in preliminary analyses of trials of tens of thousands of volunteers.


Fazeli added: “We remain most convinced by the Moderna and Pfizer data for now.”


--With assistance from Morwenna Coniam and Kit Rees.


To contact the reporters on this story:
James Paton in London at jpaton4@bloomberg.net;
Suzi Ring in London at sring5@bloomberg.net

LLP
To contact the editor responsible for this story:
Eric Pfanner at epfanner1@bloomberg.net



www.bloomberg.com/amp/news/articles/2020-11-26/astra-faces-more-vaccine-questions-after-manufacturing-error
 

djpolo

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When its damned if you do; and
damned if you don't.
What do we do ???


.

I'm sorry but I'm not taking it. The only time I took a flu shot show was back in 89 when I joined the Army. Never again since. I keep my ass at home and wear a mask when I go out. Leave once a week to get food gym at home. Im in and out of stores when I go.

 

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Fauci wants people to know that one of lead scientists who developed the Covid-19 vaccine is a Black woman

Dr. Anthony Fauci is urging Black Americans hesitant to take the Covid-19 vaccine to trust the process -- in part because one of the scientists at the forefront of the vaccine's development is a Black woman.

http://a.msn.com/01/en-us/BB1bNaCC?ocid=sf
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Anthony S. Fauci, Donald Trump standing next to a man in a suit and tie: Drs. Anthony Fauci, left, and Kizzmekia Corbett, right, flank President Donald Trump at the NIH Vaccine Research Center in March.

© Leah Millis/Reuters Drs. Anthony Fauci, left, and Kizzmekia Corbett, right, flank President Donald Trump at the NIH Vaccine Research
Center in March.

The nation's top infectious disease expert, speaking at an event hosted by the National Urban League on Tuesday, said it was important to acknowledge the US history of racism in medical research and understand how that has fostered mistrust among some Black people.

But Fauci stressed that the upcoming Covid-19 vaccines are safe and effective, adding that African American scientists have been involved in their development.

"The very vaccine that's one of the two that has absolutely exquisite levels -- 94 to 95% efficacy against clinical disease and almost 100% efficacy against serious disease that are shown to be clearly safe -- that vaccine was actually developed in my institute's vaccine research center by a team of scientists led by Dr. Barney Graham and his close colleague, Dr. Kizzmekia Corbett, or Kizzy Corbett," Fauci said.

Corbett is the National Institute of Health's lead scientist for coronavirus vaccine research. She is part of a team that worked with the biotechnology company Moderna on one of the two mRNA vaccines expected to receive emergency use authorization from the US Food and Drug Administration this month. Pfizer's vaccine candidate is the other one.

"So, the first thing you might want to say to my African American brothers and sisters is that the vaccine that you're going to be taking was developed by an African American woman," Fauci added. "And that is just a fact."

Experts are trying to build confidence
Black Americans and other people of color have been disproportionately affected by Covid-19, increasing the urgency among health experts and community leaders to build confidence and trust in the vaccine.

But skepticism among some people of color, especially Black Americans, remains high.

A study released by the COVID Collaborative, the NAACP and UnidosUS found that only 14% of Black Americans trust that a vaccine will be safe and 18% trust it will be effective. Their concerns stem largely from a history of racism in medical research and healthcare that includes incidents like the Tuskegee syphilis experiment, the study found.

Corbett told CNN's Dr. Sanjay Gupta that she sees vaccine hesitancy in Black communities firsthand. Rebuilding trust in medical institutions will take time, she said, and that's something that health experts have to accept.

"I would say to people who are vaccine-hesitant that you've earned the right to ask the questions that you have around these vaccines and this vaccine development process," she says in an episode of the CNN podcast "Coronavirus: Fact vs. Fiction."

For her part, Corbett said she is trying to help earn back that trust.

She has been outspoken on the role systemic racism has played in the pandemic, and has criticized the Trump administration for a lack of diversity on its coronavirus task force.

"Trust, especially when it has been stripped from people, has to be rebuilt in a brick-by-brick fashion," she said. "And so, what I say to people firstly is that I empathize, and then secondly is that I'm going to do my part in laying those bricks. And I think that if everyone on our side, as physicians and scientists, went about it that way, then the trust would start to be rebuilt."

Fauci addresses specific concerns
Fauci is taking a similar approach.

He said he generally hears two major concerns about the vaccines: the speed at which they were developed, and their safety and efficacy.
Though vaccines have traditionally taken years or even decades to develop, advancements in vaccine platform technology have significantly shortened that process without compromising safety or scientific integrity, Fauci said.

He also addressed concerns that pharmaceutical companies or the federal government couldn't be trusted to assess the safety of the vaccine, saying that both are advised by independent committees made up of experienced clinicians, scientists and ethicists.

Those independent experts, not politicians, determine whether the vaccine is safe for the public, he added.

"When they then say that the vaccine is safe and effective, I will tell you all that I, myself, will be perfectly comfortable in taking the vaccine and I will recommend it to my family," Fauci said.


Fauci wants people to know that one of lead scientists who developed the Covid-19 vaccine is a Black woman (msn.com)
 

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Viewpoint
October 14, 2020

Is It Lawful and Ethical to Prioritize Racial Minorities for COVID-19 Vaccines?

Harald Schmidt, PhD1; Lawrence O. Gostin, JD2; Michelle A. Williams, ScD3
Author Affiliations Article Information
JAMA. 2020;324(20):2023-2024. doi:10.1001/jama.2020.20571
COVID-19 Resource Center
related articles iconauthor interview iconmultimedia icon

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals.

The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically.1 The World Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in ways that reduce unjust health disparities.2 The ethics and legality of race-based policies in the United States have been fraught with controversy.3 This Viewpoint considers how COVID-19 vaccine priority allocations could be implemented ethically and legally.

COVID-19 and Communities of Color
Compared with the rate of COVID-19–related deaths among non-Hispanic White individuals (mortality rate, 38/100 000) and adjusting for age, the mortality rate relative to population size is 3.4-fold higher among Black individuals (mortality rate, 131/100 000), 3.3-fold higher among Indigenous and Latino communities (mortality rate for both, 125/100 000), 2.9-fold higher among Pacific Islander individuals (mortality rate, 111/100 000), and 1.3 higher among Asian populations (mortality rate, 50/100 000).4 These elevated death rates are unlikely to be explained by biological differences1 but more likely are influenced by social determinants of health, including economic privation and systemic bias. To avoid further compounding these disparities, the NASEM expressly includes “mitigation of health inequities” as 1 of the 3 foundational principles of its framework.1

The Ethical Case for Considering Race
The ethical justification for prioritizing economically worse-off racial minorities rests on epidemiological, economic, and social justice grounds.1,2,5 Economically, worse-off groups are more dependent on regular income with little or no retirement or other savings, and less able to work remotely. Epidemiologically, worse-off groups are more likely to live with multiple generations in close proximity and are typically less able to physically distance at home, at work, and while commuting to work (if they are employed), and therefore at greater risk of contracting and spreading severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Social justice rationales are based on the disparate outcomes that worse-off racial minorities, especially Black persons in the United States, have experienced in terms of higher rates of COVID-19–related unemployment, housing evictions, and hospitalizations. Ignoring these effects in allocating vaccines could exacerbate these differences, with an influence lasting likely far beyond the end of the pandemic.5

NASEM Framework
The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) commissioned the NASEM to provide recommendations to the CDC’s Advisory Committee on Immunization Practices (ACIP). ACIP will issue national guidance, implemented by the states. ACIP has indicated it would be guided by the NASEM framework, particularly the way in which minorities will be prioritized.
The NASEM framework allocates vaccines in 4 sequential phases, with distinct priority populations. Within each population group, vaccine access would be prioritized for geographic areas identified as vulnerable through a statistical measure called the Social Vulnerability Index (SVI). The SVI (developed for public health emergencies such as hurricanes or earthquakes) identifies geographic areas of vulnerability based on 15 census variables “most linked to the disproportionate impact of COVID-19 on people of color and other vulnerable populations.”1 The CDC advises state-level planners to draw on the NASEM and the ACIP frameworks, instructing planners to begin identifying “critical populations” including “people from racial and ethnic minority groups.”6 Race, therefore, could be among the explicit factors that health professionals will use to allocate scarce COVID-19 vaccines.

Are Race-Based Allocation Criteria Lawful?
The US Supreme Court uses a demanding legal standard in reviewing race-based classifications. There is no direct precedent in which courts have considered race in allocating scarce health care resources. The closest parallels are found in rulings on school access and university admissions. The critical question is whether government is permitted to consider race when seeking to ameliorate the effects of past and current discrimination. Often called “reverse discrimination,” the policy deliberately favors people of color.

In a series of cases, the court has vacillated as to whether race can be an express criterion for achieving greater equity and diversity. In striking down public school integration plans that explicitly included a student’s race, Chief Justice Roberts said, “The way to stop discrimination on the basis of race is to stop discriminating on the basis of race” (Parents Involved in Community Schools v Seattle School District No. 1, 551 US 701 [2007]). Yet the court has permitted race to be one of multiple factors in ensuring diversity in universities.7
The court has increasingly moved toward limiting the explicit consideration of race, requiring policies categorizing individuals by race to meet a “strict scrutiny” standard. Under strict scrutiny, race-based policies must be narrowly tailored to achieve a compelling governmental interest. Even if the court were to rule that promoting equity is a compelling state interest, it would still require government, wherever possible, to use means other than race to achieve equitable outcomes. Likewise, the future of race-based discrimination to remedy past and future disadvantage remains uncertain. The consideration of race in COVID-19 vaccine allocation could be a potentially attractive test case for the court given its changing composition.7

Strict judicial scrutiny would not permit 2 vaccine priority strategies. First, a health care worker could not give priority to vaccinating persons from minority groups, for instance, by skipping White people waiting in line at a health care facility. Second, public health agencies could not provide vaccines exclusively, or in larger shares, to geographic areas identified by race alone. This would not preclude distribution in proportion to the population of a vaccine through community health centers, many of which serve largely urban minority populations.

For strategies that would increase the allocation ratio above that proportionate to the population, the Supreme Court is likely to uphold racially neutral vaccine allocation criteria, which are designed to capture worse-off minorities but not explicitly. A vaccine distribution formula, therefore, could lawfully prioritize populations based on factors like geography, socioeconomic status, and housing density that would favor racial minorities de facto, but not explicitly include race.

An example of such a legally permissible approach would be to use a measure called the Area Deprivation Index (ADI), which is similar to the SVI, but does not explicitly prioritize on the basis of race. The ADI reflects the level of socioeconomic deprivation of a geographic area at the block-group level (600-3000 people) and is associated with health outcomes.8 The index integrates income, education, employment, and housing quality.

Although it does not use race as a variable, the ADI still captures structural disadvantage and systemic racism because racial minorities are far more likely to be economically worse off.1,2 The ADI therefore closely tracks racial and ethnic divides and significantly reduces potential legal concerns that are associated with using the SVI.

The methodological design of the SVI does not prescribe how its 4 domains (socioeconomic status, household composition, race/ethnicity and language, and housing and transportation) that are focused on the census tract level (1200-8000 people) should be weighed. Current guidance suggests that states will have considerable discretion in allocations.1,6 Race could therefore account for as little as one-fifteenth of the overall SVI score (if all variables were considered equally) or, depending on how the index is configured by a planner, could become far more prominent, if not determinative.

It is not clear how the Supreme Court would rule on vaccine distribution based on either the ADI or SVI, but it is likely that the ADI would be more acceptable because it does not explicitly prioritize on the basis of race.

Race in the United States
The United States is experiencing an intense reckoning with structural racism, both because of the disparate health effects of COVID-19 on racial minorities and protests over police violence. Vaccine allocation strategies should not exacerbate racial divisions yet must consider socioeconomic and racial disadvantage. Protected litigation challenging vaccine allocation plans could disrupt the implementation of a COVID-19 vaccination plan. Before implementation, ACIP should model the performance of the SVI against racially neutral standards such as the ADI, in capturing vulnerable groups while minimizing legal and ethical risks.

Policy makers should also model how many more vaccines worse-off racial minorities should receive. NASEM suggests that 10% of all vaccines be reserved for the worst-off SVI quartile in each state. In addition, states should make “special efforts” to deliver vaccines to these areas. The more intense the priority that might be given to racial minorities, the deeper the legal scrutiny will be. In addition, a seemingly arbitrary arithmetic cutoff point can invite further legal concern. An equally pragmatic yet more meaningful approach would consider COVID-19’s effects to date (for example, in terms of deaths an ADI region incurred) on worse-off racial minorities. Grounding priority decisions in objective data help justify allocation formulas both for the general public and for the judiciary.

Public health agencies will have considerable discretion in rationing scarce COVID-19 vaccines. They could become agents of change toward improving social and racial justice. Or they can become complicit in allocation strategies that, once again, disproportionately favor the better-off, White majority. Racially neutral approaches must be implemented to advance social and racial justice in the United States.

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Article Information
Corresponding Author: Lawrence O. Gostin, JD, O’Neill Institute for National & Global Health Law, Georgetown University, 600 New Jersey Ave NW, McDonough 568, Washington, DC 20001 (gostin@georgetown.edu).
Published Online: October 14, 2020. doi:10.1001/jama.2020.20571
Conflict of Interest Disclosures: None reported.
References
1.
Gayle H, Foege W, Brown L, Kahn B, eds. A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus. National Academy of Sciences, Engineering, and Medicine; August 2020. Accessed September 21, 2020. https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus
2.
World Health Organization Strategic Advisory Group of Experts (WHO/SAGE). Values framework for the allocation and prioritization of COVID-19 vaccination. September 14, 2020. Accessed September 14, 2020. https://apps.who.int/iris/bitstream/handle/10665/334299/WHO-2019-nCoV-SAGE_Framework-Allocation_and_prioritization-2020.1-eng.pdf?ua=1
3.
Persad G, Peek ME, Emanuel EJ. Fairly prioritizing groups for access to COVID-19 vaccines. JAMA. Published online September 10, 2020. doi:10.1001/jama.2020.18513
ArticlePubMedGoogle Scholar
4.
APM Research Lab Staff. The color of coronavirus: COVID-19 deaths by race and ethnicity in the US. Published September 16, 2020. Accessed September 29, 2020. https://www.apmresearchlab.org/covid/deaths-by-race#age
5.
Schmidt H. Vaccine rationing and the urgency of social justice in the COVID-19 response. Hastings Cent Rep. 2020;50(3):46-49. doi:10.1002/hast.1113 PubMedGoogle ScholarCrossref
6.
Covid-19 vaccination program interim playbook for jurisdiction operations. Centers for Disease Control and Prevention. September 16, 2020. Accessed September 16, 2020. https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf
7.
Persad G. Allocating medicine to address disparities. SSRN. Posted September 28, 2020. Last revised October 5, 2020. Accessed October 5, 2020. http://ssrn.com/abstract=3699769
8.
Kind AJH, Buckingham WR. Making neighborhood-disadvantage metrics accessible—the Neighorhood Atlas. N Engl J Med. 2018;378(26):2456-2458. doi:10.1056/NEJMp1802313 PubMedGoogle ScholarCrossref


 

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Amid history of mistreatment, doctors struggle to sell Black Americans on coronavirus vaccine

Stuart Anderson, left, and Lamont Mitchell of the Anacostia Coordinating Council talk with Totreana Johnson about the pending coronavirus vaccine. Volunteer Tayla Daniel is at the rear of the photo. Johnson said she is willing to take the vaccine, but many other Black Americans are not.
Stuart Anderson, left, and Lamont Mitchell of the Anacostia Coordinating Council talk with Totreana Johnson about the pending coronavirus vaccine. Volunteer Tayla Daniel is at the rear of the photo. Johnson said she is willing to take the vaccine, but many other Black Americans are not. (Michael Robinson Chavez/The Washington Post)


 

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Boston Reverend Enlists Dr. Fauci
To Help Black Community Get Behind COVID-19 Vaccine




Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a White House Coronavirus Task Force press briefing at the White House on November 19, 2020. (Tasos Katopodis/Getty Images)

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a White House Coronavirus Task
Force press briefing at the White House on November 19, 2020. (Tasos Katopodis/Getty Images)


A Boston pastor recently invited Dr. Anthony Fauci for a Zoom meeting with her congregation to help build confidence in coronavirus vaccines.

Anti-vaccination activists have been spreading false fears about vaccinations since the pandemic began, but health officials are worried about doubters with a well-founded distrust of the medical community, which experimented first on enslaved people and into the last century on Black Americans.

A survey by the COVID Collaborative found only 14% of Black Americans said they thought a coronavirus vaccine would be safe. Rev. Liz Walker of Roxbury Presbyterian Church said she asked Fauci to speak to her parishioners because she was shocked by the level of distrust within her own community.


“I was really surprised at how many parishioners, how many people, not just in the church, but in the community, said they weren't going to take the vaccine,” she says. “So I wanted to do something about that because I sincerely believe we need to take it.”

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Studies show Black and Latino communities face disproportionate exposure to the virus, living largely in urban areas, and the Centers for Disease Control and Prevention says they're more likely to get infected, sick or die.

In a public service announcement, health professionals in the Black Coalition Against COVID-19 are telling vaccine makers they must earn the trust of Black Americans. Much of that reticence stems from a historical distrust of the medical community that launched the decades-long Tuskegee Study and profited from Henrietta Lacks' cervical cancer.

It goes as far as Black people’s experiences with the health care system today, Walker says.

“It's ironic, but the very reason that we feel we're getting sicker [with COVID-19] is because we feel we haven't been properly dealt with in the health care arena,” Walker says. “Now, you add to that the political situation, so you have a perfect storm of problems in my community of wanting to take this vaccine.”

In urging the people of Roxbury Presbyterian to get vaccinated, Fauci told churchgoers that he understands the “disproportionate suffering” the Black community has gone through, and that’s one of the key reasons why they need to take the vaccine.

“It is something that is really extraordinarily unfortunate, and the reasons for that, I do hope when this is all over, we address, mainly the social determinants of health and the inequities that you've been faced with essentially forever,” Fauci said. “Don't deprive yourself of the advantage of an extraordinarily important advance in science by not getting vaccinated. Protect yourselves, your family and your community.”


Rev. Liz Walker (left) and Pastor Gloria White-Hammond (right)'s Zoom with Dr. Anthony Fauci. (Screenshot)
Rev. Liz Walker (left) and Pastor Gloria White-Hammond (right)'s Zoom with Dr. Anthony Fauci. (Screenshot)


Walker says some people were swayed by Fauci’s words and many others said they would reconsider their plans not to take a vaccine. What struck her the most was the level of transparency Fauci brought to the conversation, she says.

“There is a growing distrust about everything in this country,” she says. “I don't think it's limited to African Americans or people of color. I think it's across culture, across race. And that has to be fixed.”

Fauci told the parishioners that for him as well as the other doctors and researchers involved, providing life-saving vaccines has nothing to do with politics — it is his purpose.

Walker says she felt connected to that calling. If rolling up her sleeves and getting a shot publicly will convince more people to get vaccinated, she says she will do it.

“I think it's going to take that kind of leadership, and after all, that's what I'm supposed to be as a preacher. So I think I will do it,” she says. “A lot of other people are stepping up to this plate and that gives me inspiration. So I think the more of us that do it, the more it'll continue and then change may come. I say that with hope, great hope.”


Walker says some people were swayed by Fauci’s words and many others said they would reconsider their plans not to take a vaccine. What struck her the most was the level of transparency Fauci brought to the conversation, she says.

“There is a growing distrust about everything in this country,” she says. “I don't think it's limited to African Americans or people of color. I think it's across culture, across race. And that has to be fixed.”

Fauci told the parishioners that for him as well as the other doctors and researchers involved, providing life-saving vaccines has nothing to do with politics — it is his purpose.

Walker says she felt connected to that calling. If rolling up her sleeves and getting a shot publicly will convince more people to get vaccinated, she says she will do it.

“I think it's going to take that kind of leadership, and after all, that's what I'm supposed to be as a preacher. So I think I will do it,” she says. “A lot of other people are stepping up to this plate and that gives me inspiration. So I think the more of us that do it, the more it'll continue and then change may come. I say that with hope, great hope.”


Boston Reverend Enlists Dr. Fauci To Help Black Community Get Behind COVID-19 Vaccine | Here & Now (wbur.org)
 

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5 Reasons to Wear a Mask Even After You’re Vaccinated

As an emergency physician, Dr. Eugenia South was in the first group of people to receive a covid vaccine. She received her second dose last week — even before President-elect Joe Biden.

Yet South said she’s in no rush to throw away her face mask.



“I honestly don’t think I’ll ever go without a mask at work again,” said South, faculty director of the Urban Health Lab at the University of Pennsylvania in Philadelphia. “I don’t think I’ll ever feel safe doing that.”


And although covid vaccines are highly effective, South plans to continue wearing her mask outside the hospital as well.


Health experts say there are good reasons to follow her example.


“Masks and social distancing will need to continue into the foreseeable future — until we have some level of herd immunity,” said Dr. Preeti Malani, chief health officer at the University of Michigan. “Masks and distancing are here to stay.”



Malani and other health experts explained five reasons Americans should hold on to their masks:


1. No vaccine is 100% effective.
Large clinical trials found that two doses of the
Moderna and Pfizer-BioNTech vaccines prevented 95% of illnesses caused by the coronavirus. While those results are impressive, 1 in 20 people are left unprotected, said Dr. Tom Frieden, a former director of the Centers for Disease Control and Prevention.

Malani notes that vaccines were tested in controlled clinical trials at top medical centers, under optimal conditions.

In the real world, vaccines are usually slightly less effective. Scientists use specific terms to describe the phenomenon. They refer to the protection offered by vaccines in clinical trials as “efficacy,” while the actual immunity seen in a vaccinated population is “effectiveness.”


The effectiveness of covid vaccines could be affected by the way they’re handled, Malani said. The genetic material used in mRNA vaccines — made with messenger RNA from the coronavirus — is so fragile that it has to be carefully stored and transported.

Any variation from the CDC’s strict guidance could influence how well vaccines work, Malani said.


2. Vaccines don’t provide immediate protection.

No vaccine is effective right away, Malani said. It takes about two weeks for the immune system to make the antibodies that block viral infections.

Covid vaccines will take a little longer than other inoculations, such as the flu shot, because both the Moderna and Pfizer products require two doses. The Pfizer shots are given three weeks apart; the Moderna shots, four weeks apart.

In other words, full protection won’t arrive until five or six weeks after the first shot. So, a person vaccinated on New Year’s Day won’t be fully protected until Valentine’s Day.



3. Covid vaccines may not prevent you from spreading the virus.

Vaccines can provide two levels of protection. The measles vaccine prevents viruses from causing infection, so vaccinated people don’t spread the infection or develop symptoms.

Most other vaccines — including flu shots — prevent people from becoming sick but not from becoming infected or passing the virus to others, said Dr. Paul Offit, who advises the National Institutes of Health and Food and Drug Administration on covid vaccines.

While covid vaccines clearly prevent illness, researchers need more time to figure out whether they prevent transmission, too, said Phoenix-based epidemiologist Saskia Popescu, an assistant professor in the biodefense program at George Mason University’s Schar School of Policy and Government.

“We don’t yet know if the vaccine protects against infection, or only against illness,” said Frieden, now CEO of Resolve to Save Lives, a global public health initiative. “In other words, a vaccinated person might still be able to spread the virus, even if they don’t feel sick.”

Until researchers can answer that question, Frieden said, wearing masks is the safest way for vaccinated people to protect those around them.


4. Masks protect people with compromised immune systems.

People with cancer are at particular risk from covid. Studies show they’re more likely than others to become infected and die from the virus, but may not be protected by vaccines, said Dr. Gary Lyman, a professor at Fred Hutchinson Cancer Research Center.

Cancer patients are vulnerable in multiple ways. People with lung cancer are less able to fight off pneumonia, while those undergoing chemotherapy or radiation treatment have weakened immune systems. Leukemia and lymphoma attack immune cells directly, which makes it harder for patients to fight off the virus.

Doctors don’t know much about how people with cancer will respond to vaccines, because they were excluded from randomized trials, Lyman said. Only a handful of study participants were diagnosed with cancer after enrolling. Among those people, covid vaccines protected only 76%.

Although the vaccines appear safe, “prior studies with other vaccines raise concerns that immunosuppressed patients, including cancer patients, may not mount as great an immune response as healthy patients,” Lyman said. “For now, we should assume that patients with cancer may not experience the 95% efficacy.”


Some people aren’t able to be vaccinated.

While most people with allergies can receive covid vaccines safely, the CDC advises those who have had severe allergic reactions to vaccine ingredients, including polyethylene glycol, to avoid vaccination. The agency also warns people who have had dangerous allergic reactions to a first vaccine dose to skip the second.

Lyman encourages people to continue wearing masks to protect those with cancer and others who won’t be fully protected.


5. Masks protect against any strain of the coronavirus, in spite of genetic mutations.

Global health leaders are extremely concerned about new genetic variants of the coronavirus, which appear to be at least 50% more contagious than the original.


So far, studies suggest vaccines will still work against these new strains.



One thing is clear: Public health measures — such as avoiding crowds, physical distancing and masks — reduce the risk of contracting all strains of the coronavirus, as well as other respiratory diseases, Frieden said. For example, the number of flu cases worldwide has been dramatically lower since countries began asking citizens to stay home and wear masks.

Masks will remain effective,” Malani said. “But careful and consistent use will be essential.”


The best hope for ending the pandemic isn’t to choose between masks, physical distancing and vaccines, Offit said, but to combine them. “The three approaches work best as a team,” he said.



 
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