Category: Covid-19 Vaccine

The Food and Drug Administration is expected to issue new rules for an emergency use authorization for a coronavirus vaccine and they will make it very unlikely that an inoculation will be cleared before Election Day, according to a report.

The FDA is issuing the guidance to increase transparency and public trust amid polls about the politicization of the process to roll out a vaccine, according to the Washington Post.

The Pew Research Center has reported that the percentage of Americans who said they would get the shot if it were available now has dropped to just over 50 percent from 72 percent in May, according to the paper.

New rules are expected to be far stricter than those used for emergency clearance of hydroxychloroquine or convalescent plasma, a treatment that uses blood plasma from recovered patients, the news outlet reported.

Under the new guidance, the FDA would ask drug makers seeking an emergency use authorization, or EUA, to follow participants in late-stage clinical trials for a median of at least two months, beginning after they get a second shot, two people familiar with the matter told the Washington Post on condition of anonymity.

The agency which has said any vaccine would have to be 50 percent more effective than a placebo also is likely to look for at least five severe cases of the disease in the placebo group for each trial, as well as some cases among older people, the paper reported.

President Trump, who has predicted that a vaccine could be ready by Nov. 3, said during a recent interview on Fox News that his Democratic opponents have been criticizing the speedy timeframe of a potential US vaccine as a political move to harm him before the election.

Its hard to imagine how an (EUA) could possibly occur before December, Paul Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia and a member of the FDAs advisory board on vaccines, told the outlet.

Moderna and Pfizer, which began Phase 3 clinical trials in the US on July 27, have given second doses to less than half their participants.

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FDA considering tougher rules that could push COVID-19 vaccine past Election Day - New York Post

The COVID-19 vaccine got political this week. Heres a look at the facts.  The Mercury News

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The COVID-19 vaccine got political this week. Heres a look at the facts. - The Mercury News

So far the animals havent shown any ill effects from the vaccine that weve given them, so thats good. If we can show that we can protect the animals against infection, that would be really good, Dr. Steven Zeichner, a professor of pediatrics at UVA, said.

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UVA researchers working on COVID-19 vaccine - WWBT NBC12 News

A new Pew Research Poll showed only of half Americans would get a vaccine, thats down from 72 percent in May.

FORT WORTH, Texas As the United States nears 7 million COVID-19 cases, there is increased focus on when a vaccine could be available.

Dr. Peter Hotez is a vaccine scientist and Dean of the National School of Tropical Medicine at Baylor College of Medicine. His estimate for a vaccine is next spring or summer.

We're doing as fast as we can, but it's still not a quick fix, Hotez said. You've got to give it time to show that there's a difference between those who are vaccinated in the placebo to know that they're going to work.

Thats the same estimate CDC director Robert Redfield gave last week.

Moderna, Pfizer and AstraZencas partnership with Oxford University are the furthest along in trials.

The U.S. already pre-ordered millions of doses to allow the companies to start making them.

I don't see that will have a good indication about one of these working till the end of the year, which again is still a world land speed record, Hotez said.

A new Pew Research Poll showed only of half Americans would get a vaccine, thats down from 72 percent in May.

Hotez says thats because Operation Warp Speed hasnt put out a strong communications effort to counter misinformation.

No communications means that you allow anti-vaccine and anti-science groups to dominate your communications, Hotez said. Were going to need more scientists speaking out to counter that.

Hotez says part of the issue is the White House previously abusing Emergency Use Authorizations and undermining top scientists.

The Department of Health and Human Services and operation warp speed has a lot of damage control and I hope they have they show the willingness to be able to do that, Hotez said.

Despite issues with the CDC and FDA, Hotez says he backs the Vaccines and Related Biological Products Advisory Committee that will have the final say.

The American people can trust that process is one of the most robust in the world in terms of releasing vaccines that are both that both work and are safe, he said.

The biggest unanswered question after the timeline is who will receive the vaccine first.

The National Academies of Sciences, Engineering, and Medicine released a tier approach prioritizing vulnerable populations and frontline workers, but the federal government has so far not unveiled plans.

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Scientist weighs in on when to expect a COVID-19 vaccine and how approval will work - WFAA.com

SAN FRANCISCO, Calif. (KRON) -- On todays edition of Rob Blacks Winners and Losers, financial expert Rob Black talks with KRON4s James Fletcher about the grocery delivery boom, a looming recession and Coke stocks.

Double-dip recession likely if no new stimulus: Some say Congress's deadlock over a second stimulus package for Americans will tip the nation back into recession.

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Rob Blacks Winners & Losers: COVID-19 vaccine trial, Nike and Xbox - KRON4

(WTNH) Weve heard promising news about the Pfizer vaccine and weve been following how Yale has been running some of those clinical trials.

Infectious Disease Specialist at Yale Medicine and Associate Professor at Yale University, Dr. Onyema Ogbuagu, gives us an update on the trials, and talks about how the criteria for being in the vaccine trials has changed in the video above.

Recent news of the death of baseball player Tom Seaver brought attention to the condition called Lewy Body Dementia. A newly-released documentary on Robin Williams also revealed that the comedian suffered from Lewy Body Dementia in his final days.

Dr. Leon Meytin, Movement Disorders Specialist Hartford HealthCares Chase Family Movement Disorders Center, shines more light on the condition, the symptoms and what treatments are available in the video below.

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Experts give update on Yales clinical trials of Covid-19 vaccine; bring awareness to Lewy Body Dementia - WTNH.com

The next phase of the pandemic battle is upon us, so hike up your sleeves.

The U.S. Centers for Disease Control released a long-awaited playbook for rolling out COVID-19 vaccines this week, urging state and local governments to shift into high gear by forming critical vaccination program planning and coordination teams and implementation committees reflecting the community at large.

Vaccines should be free for all who wish to get them; and the CDC itself will take vaccine orders, and fill and ship them to local health departments and providers, the plan says.

The vaccination program will unfurl in three distinct phases, with supplies limited in the early weeks. First in line for shots should be health care personnel likely to be exposed to, or to treat people with, COVID-19; those with underlying medical conditions and people aged 65 and older, who are at increased risk for severe illness; and other essential workers. The specifics will differ from place to place depending on local needs, the CDC said.

That puts the onus on state and local health departments to fill in the many blanks of a massive, nationwide vaccination effort including how to assure that vaccines would be kept at super-cold temperatures, as some would require. That work appears in its infancy in California and its four populous southern counties.

Of course, there is no vaccine yet. There are, however, 36 candidates in clinical evaluation worldwide as of Sept. 17, and another 146 in preclinical evaluation, according to the World Health Organization.

The government is keen to remind us that a vaccine is imminent, and I think this document is part of the virtue-signaling around that, said Andrew Noymer, an epidemiologist and population health scientist at UC Irvine. But its a good prompt for state and local health departments. They may not have much of a plan yet I mean, theres no vaccine yet but ask them again in four weeks. Theres a lot they can do in four weeks.

In an emailed statement about the Golden States vaccination rollout plan, the California Department of Public Health said it continues to work diligently to prepare for the eventual distribution and administration of COVID-19 vaccines in California. Planning will involve local health departments, multiple state agencies and community-based stakeholders.

Officials are closely monitoring information about the candidate vaccines, their Phase 3 trials, the FDA review process and any independent evaluations. CDPH will need evidence that the vaccine candidates are safe and effective before distributing them, it said.

In San Bernardino County, officials are mulling how to use the infrastructure created for COVID-19 testing sites, staffing, communications, organization and logistics to administer both flu vaccines and an eventual COVID-19 vaccine, said spokesman David Wert.

Thats an infrastructure skeleton likely to be tapped in Los Angeles, Orange, Riverside and other counties as well, though the CDC also wants individual health providers to administer vaccines eventually as well.

In a best-case scenario mapped out by CDC, there could be some 40 million doses of vaccine available by the end of the year.

The president has been hopeful for a vaccine before Election Day, though public health experts say the first doses likely wont be available until much later in the year, and most Americans wont likely get one until well into 2021.

As of now, two doses are required, about a month apart. To inoculate 300 million people most of the U.S. population 600 million doses would be needed.

Vaccines usually take years to produce sometimes decades and the compressed timetable here has prompted worries that speed may trump safety.

I am concerned that COVID-19 vaccines have skipped much of the safety research that other vaccines go through, such as animal research to assess harm prior to human testing and three-year clinical trials to ensure both efficacy and to determine the side-effect profile, said pediatrician Bob Sears of Capistrano Beach by email.

Throw in the fact that hundreds of millions of doses are already bought and paid, our FDA director really has no choice but to approve them no matter what the safety trials show. No one wants to waste a few billion dollars especially not now.

Sears who is pro-informed consent and anti-mandate on vaccines, and was slapped by the Medical Board of California for being too free with medical exemptions for children said people certainly can opt in to gain whatever level of protection a vaccine can offer, but he hopes it remains a free choice.

Because if this vaccine is like the flu shot and the whooping cough vaccine, it WONT prevent the spread of disease, Sears said. It will only offer some reduction in personal symptoms. But youll still get sick and be contagious to others. The vaccine isnt going to help eliminate the disease public health measures and the natural progression of this virus will see to that.

The CDCs playbook says precious little about children and whether theyll be vaccinated, said Noymer of UCI. The leading vaccine candidates are being tested on adults, not children.

Technically, findings from the trials are applicable to those 18 and up. Im not comfortable giving kids a vaccine that hasnt been tested on them, Noyer said. Theres an epidemiological rationale in this case that we dont need to vaccinate kids because, by and large, they dont get very sick, so we could just vaccinate everyone else. But theres no unanimity on that. In my mind, if were not testing the new vaccines on kids, we should be careful about giving them to kids.

CDC spokeswoman Kristen Nordlund said recommendations for pediatric populations, and other information in the interim playbook, will be updated as new information becomes available.

The two drug companies at the front of the COVID vaccine-development pack Moderna and Pfizer released heretofore confidential details of how theyre evaluating their vaccines and what evidence theyll use to determine whether they work on Thursday, in an effort to tamp down concerns. Its a rare move, but worries persist.

They run trials, stop as soon as theres a scintilla of positive evidence and before other evidence comes in to make them look bad, and reap windfall profits, Noymer said. I hope it comes in like a home run, then we can all breathe a sigh of relief and say, It works.

But if the data reveals that its only 50 percent better than nothing the low bar the Food and Drug Administration has set for COVID vaccines its unclear how much good it would really do.

Im more worried that the trials are just going to show, This doesnt work, sorry, than I am that theres going to be some incredible problem getting the vaccines delivered, Noymer said.

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Free COVID-19 vaccines for all, says new CDC playbook ...

News in the past week has not been encouraging that COVID-19 vaccine development is on track. In fact, claims by President Trump about the likely end of the pandemic seem quaintly like groundhog day as he made a similar claim back in early April when the number of US COVID-19 deaths was just 9,619. On September 18, US COVID deaths reached 203,171. Understanding the current situation is vital not just for investors in the COVID-19 space, but also more generally as the economic shutdowns around the world are creating chaos for many industries. Here I update my commentary about COVID-19 vaccine development, because the arrival of a vaccine is being touted as the end of the pandemic. There is as yet no clarity that a safe and effective COVID-19 vaccine will be developed, and even if this does happen, the timeline for it becoming available is unclear. Also how quickly the economy will normalise is not well thought through. Investors need to pay close attention because there is a lot at stake.

The times are so bizarre that it is common now to overlook Presidential missteps and just act as if they didnt happen. Reality is different. People do pay attention. It is clear that President Trump is determined to announce the release of a COVID-19 vaccine before early November, no matter what. What seems not being considered is where this is leading.

Presidential interference keeps coming, the latest being an attack by the President on CDC Director Robert Redfield who stated clearly at a Senate hearing that his view was that a vaccine might not become available to the general public until the second half of 2021. Perhaps without thinking, he baited the President by making the statement that wearing a mask is perhaps more important than a vaccine because a mask protects whereas a vaccine will not be effective for all people. Trump responded, after hearing the testimony, that the information was incorrect about vaccine distribution and reference to the value of masks as a mistake. The CDC backed off in response to the Presidents attack, but later retracted the backoff, which had clearly been an attempt to appease the political attack.

The extraordinary thing about the above exchange on the timing of vaccine (if one gets Phase 3 approval) release and value of masks, is that some press is seeking to blame the CDCs messaging, which is clearly all over the place due to factual reporting having to cope with pushback and accusation of lying by the President.

The point is that the public understands what is going on. Vaccines need public acceptance and support or they cant be effective (even if they are proved to be safe and efficacious). A recent poll makes clear that public support for a COVID-19 vaccine is wavering. In April, 72% of US adults said they would get a COVID-19 vaccine when available. This has fallen 21 points to 51% today, with a significant part of this fall (8%) happening in the past month as the independence of the FDA from political interference has become a headline issue. This fall in intention is similar for both Republicans and Democrats. Another poll has just 39% of respondents saying that they would get a Government approved COVID-19 vaccine, with 23% saying no and 36% unsure.

The above numbers are not enough to achieve successful population-wide protection even based on a very effective vaccine.

There is huge pressure on the Phase 3 COVID-19 vaccine trials because everyone wants the world economy to resume and also because there are fortunes to be made from a successful vaccine, notwithstanding that the work has been significantly funded by the public purse for some companies (e.g., Moderna, (NASDAQ:MRNA)). There is also a Presidential candidate seeking political gain.

The above makes for a really unhelpful environment in which to conduct really complex work, that is made much more problematic by cutting corners on the Phase 1 & 2 trials. Usually a vaccine candidate gets into Phase 3 with a lot of background work done and hence some confidence about its efficacy and safety. While there seem to be indications of efficacy (although still too early to be clear about this) the safety profiles for the candidate vaccines are very limited going into the Phase 3 trials.

Some parties see the AZD1222 Phase 3 trial as a formality that needs to be pushed through regardless. This isnt surprising when the earlier stages have been rushed through, scale-up is already well advanced, planning for public release advanced and formal agreements concluded about vaccine delivery in many markets. To some this all means that the vaccine projects are now in a tedious formal approvals process that is wasting time.

The reality is different as the AZD1222 trials were paused recently because of a serious adverse event in the UK section of the trial.

There are many details about the trials that need close attention. Even a lay person can get a sense of this by looking closely at details of the trials. For example, with the AstraZeneca/Oxford Phase 3 trial(s), the start was for 30,000 volunteers in the UK, Brazil and South Africa. Enrolment for these 30,000 volunteers continued the criteria used in earlier trials. Only healthy 18-55 years old were eligible. This is the cohort that produced the pause because at least one (and possibly more, see below) adverse events occurred which required examination. There is another major cohort in the Phase 3 examination of the AstraZeneca vaccine in the US which involves a further 30,000 volunteers. The enrolment criteria for these volunteers is broader, encompassing people with possible immune system dysfunction. So this is a more risky cohort.

The UK, Brazilian and South African sections of the Phase 3 trial have been resumed (with 18,000 individuals vaccinated so far although it isnt clear whether all 18,000 have yet received the second dose), while the US Phase 3 trial (involving a more at risk cohort) remains paused. Here is the cohort included in the US trial : US are recruiting up to 30,000 adults aged 18 years or over from diverse ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centres outside the US are included based on predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly.

Whether the reason for the pause in the Phase 3 trial continuing in the US is just slow bureaucracy in the US, lack of sufficient information to make a decision to restart the trial, or it reflects a concern about this population being more at risk remains to be seen. It does seem that there might be more to the story than just tardiness by the FDA, as a report indicates that NIH leaders at the highest level are very concerned and AstraZeneca might be being viewed as less than forthcoming with needed information. Of significant importance to the US, the vaccine needs to be safe for the obese and those with type 2 diabetes. Dr. Ezekiel Emanuel Vice-Provost for Global Initiatives at the University of Pennsylvania claims that up to 40% of the US population have existing health conditions that would qualify them for priority vaccination. Is this large group included in safety considerations yet?

Details, details: Regarding the pause in the trial, in the absence of clear statements information leaks out piecemeal, which either exaggerates problems or possibly hides issues that need to be faced. My reading of various initial reports, that claim to be sourced from people familiar with the UK trial, suggests that there may have been 2 or even 3 adverse events that required scrutiny. The first which one report said led to a brief pause that seems not to have been reported, may have involved a person who was diagnosed with MS after receiving the vaccine (or placebo). This seems to have been quickly dismissed as not being vaccine-related. The second report which led to the publicised pause was due to a neurological condition, which seems to have been reported as (and also disputed) to be transverse myelitis. Then there is another report which suggests that there might be two such events (or is this referring to the earlier MS diagnosis?).

A more recent CNN report based on an internal safety report from AstraZeneca (dated September 10 and sent to doctors running the trial on September 11) states that a previously healthy 37-year-old woman experienced confirmed transverse myelitis 14 days after receiving the second dose of the vaccine (initial dose early June, second dose late August). The report states that she tripped on September 2 while running, and the next day she had difficulty walking, weakness in her arms, pain and reduced sensation in her torso, headache and reduced ability to use her hands. She was hospitalised on September 5. The report stated in 2 places that the patient had a confirmed diagnosis of transverse myelitis. The patient had no prior history of neurological symptoms or significant illnesses. The patient began to recover quickly and after 4 days her symptoms were improving.

I noted in a previous article (which included comments on the AstraZeneca/Oxford vaccine) that my reading of the Phase I/II trial results for AZD1222 was that only 10 of 1,077 healthy volunteers had received a second dose of the vaccine. This could mean that the basis for the Phase 3 trial (2 doses) was based on results from 10 healthy volunteers. If this is the case, there are reasons to be quite cautious about the report of a serious adverse event as a result of the second dose.

Of even more concern is that the CNN report of the internal AstraZeneca safety report, refers to volunteers in the trial who "developed unexplained neurological symptoms including changed sensation or limb weakness." Quoting the CNN report again: The document goes on to say that "after independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine."

So the CNN report clearly indicates that the AstraZeneca report is referring to more than one adverse event involving neurological symptoms. Perhaps the 37-year-old woman is the only person who was hospitalised?

Clearly, there is huge reluctance (in part because of massive political interference) to suggest that there might be a problem with the vaccine. On the other hand, vaccines have to be REALLY safe to be administered to millions of people, many of whom are far from being in good health. The Oxford University site concerning the vaccine trial does not mention the nature of the adverse event. Given the need for public confidence, it isnt clear to me that AstraZeneca and Oxford University hiding behind medical confidentiality is useful.

The confronting point is that the vaccine used in the Phase 3 trial has already been scaled up and is being manufactured. Of course, this never happens in normal vaccine development, because only after safety and effectiveness have been established does a finished version of the vaccine get scaled up. One can see why there is huge resistance to acknowledging that there might be a problem.

The pharmaceutical industry is alert to the problem of community distrust and the CEOs of 9 major companies with leading vaccine candidates (including Pfizer, BioNTech (NASDAQ:BNTX), AstraZeneca and Moderna) have already stated that any decision about seeking approval (especially in relation to safety and efficacy) will be based on science and not politics.

Yesterday, acknowledging the seriousness of the situation, Pfizer and Moderna announced further that they would release information about the Phase 3 trial protocols early to provide transparency. Perhaps they have come forward because, in addition to the COVID-19 vaccine being the first coronavirus vaccine, the Pfizer/BioNTech and Moderna programs are using mRNA technology that has not been used in a vaccine before. AstraZeneca also indicated that it would also release protocols for its Phase 3 trial.

Modernas Phase 3 trial involves 2 doses a month apart and enrolment of 30,000 adults. Inclusion criteria for the trial include participants at high risk of SARS-CoV-2 infection (appreciable risk of exposure to the virus) who are healthy or with pre-existing conditions that are stable. Exclusions include those who are ill at the time of the first dose, and those with HIV that is not well controlled. The Moderna website states that 25,296 individuals have already enrolled, with 10,025 participants having received their second injection. The trial conditions have recently been updated slightly and a detailed protocol now published.

Details as to how efficacy will be determined have been given by Pfizer and Moderna. Basically this involves reviewing emergence of COVID-19 cases in treatment versus control (placebo) volunteers. The FDA requires 50% success of a vaccine for it to be called efficacious. While Pfizer is being a bit vague about timing of readouts, Moderna is thinking that readout should be reported by end of year or early next year.

It is not yet clear how AstraZeneca, Pfizer or Moderna plan to be more transparent about adverse events.

This report has more technical detail than is normal for a Seeking Alpha article, but the subject matter is of such critical importance to investors that I think these matters need to be raised. Whether or not a vaccine gets developed and if so when it can be released is vital information as a lot rests on these issues.

My take at the moment remains that we dont have sufficient information to know if it will be possible to develop a safe and effective COVID-19 vaccine. If this proves possible, when such a vaccine might become generally available is also unclear, although it is almost certain that the second half of 2021 is the earliest it might become available, unless safety is disregarded and an unvalidated vaccine just gets pushed out. Even if this happens, I suspect the public will be cautious and not enough people will accept it to make it effective. I suspect that the vaccine developers know that they must re-establish public confidence in the vaccine development process, and Pfizer and Moderna have made a start. AstraZeneca says it will, but currently there are unanswered questions about the seriousness of the adverse event(s) and indeed how many there have been might be in question.

It might be that CDC Director Robert Redfields comment that a mask is a safer option could be what we have to hold on to in 2021 and even beyond (subject to effective treatments and preventatives becoming available to provide further protection). Social distancing, lockdowns, lots of testing and contract tracing with quarantine may have to be accepted. Australia (837 deaths) has just been through a recent outbreak in Victoria which it seems to have controlled through a strict lockdown. The alternative for the US if this is unacceptable may be coping with an ever-rising death toll (which was 203,171 on September 18). Investors waiting to see who will win the COVID-19 vaccine race (if there is going to be a winner) need to be patient and hope that the public gets more confident about the process.

I am not a financial advisor, but I have a background in biotech both from a technical and also investor perspective. If my commentary helps you and your financial advisor to think about the impact of the COVID-19 pandemic on your overall investment strategy and whether you want to invest in companies involved with the COVID-19 pandemic, please consider following me.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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COVID-19 Vaccine Car Crash | Seeking Alpha

As trust in federal health agencies has withered over the last few months, a group of Black physicians has been working on an antidote: creating their own expert task force to independently vet regulators decisions about Covid-19 drugs and vaccines as well as government recommendations for curbing the pandemic.

Organized by the National Medical Association founded in 1895 as an answer to racist professional societies excluding Black doctors the committee is meant to safeguard against any unscientific guidance from the Centers for Disease Control and Prevention and the Food and Drug Administration.

Its necessary to provide a trusted messenger of vetted information to the African American community, said Leon McDougle, a family physician and president of the NMA. There is a concern that some of the recent decisions by the Food and Drug Administration have been unduly influenced by politicians.

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Just one of the examples he gave was the agencys go-ahead to use hydroxychloroquine against Covid-19 even though there was no reliable evidence that it worked, and some indication that it could cause heart damage. The FDA later back-tracked and revoked the authorization.

McDougle frames the new task force as a way to address the suspicion that has sprouted up around Covid-19 vaccines. Some worry that, in being developed at warp speed, the shots might not be safe or properly tested before theyre approved, and the anxiety is only heightened for those whove been alienated by the medical system. Thats part of the reason that certain patients of color are especially wary of taking part in the clinical trials and those concerns may well persist even if adequate studies are done and a vaccine hits the market.

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I think this will help to increase uptake in the African American community, if members of our task force give it the green light, McDougle said. But he emphasized that their stamp of approval would come only if data show that the vaccine is, in fact, effective and safe.

Theyll also be evaluating how well the clinical trial participants represent the demographic breakdown of the American population, as well as the fairness of the federal plans to distribute a vaccine both of which are especially important given the disproportionate impact that the pandemic has had on Black, Latino, and Native American communities.

There is a need for this task force. We need a trusted organization to take the lead on this effort, said emergency physician Uch Blackstock, the founder and CEO of the consulting firm Advancing Health Equity, who is not a member of the NMA. What weve seen in terms of political interference in the FDA and CDC has really undermined what little trust the Black community had.

While the NMA may not be a household name for the lay public, Blackstock added, because they are an organization of Black physicians led by Black physicians, what they ultimately say and recommend will have significant influence on whether people take the vaccine or not.

(McDougle didnt know how many members the NMA currently has, and the executive director did not respond to repeated requests for comment.)

The task forces leaders are still figuring out exactly how it will work. When asked what would happen if the FDA authorizes the use of a product without releasing the full data to support it as was the case with the antiviral drug remdesivir in May McDougle said that because some of the members are also involved with federal committees, he hopes that they would have access to those statistics, and that there wouldnt be much of a lag between a governmental decision and the NMAs review.

To scholars who study vaccine acceptance, the task force has the potential to either increase immunization rates or deepen mistrust, which may well be warranted. Under normal circumstances, Saad Omer, director of the Yale Institute for Global Health, would prefer that everyone simply look to the FDA and the CDCs Advisory Committee on Immunization Practices. As a public health professional, the more the mainstream process is followed, the better, he said.

But he knows these arent normal circumstances. He pointed out that there is a precedent: Other professional societies representing some medical specialties have their own committees, but their recommendations tend to harmonize with the CDCs. Of the NMA task force, he said, I wish they didnt have to, but if they have to, I can understand why theyre doing it.

The idea came from Rodney Hood, an internal medicine doctor in San Diego. Even before the Trump administration, he knew his patients didnt have much faith in government. They trusted him, their doctor, and he was their source of evidence-based advice. But as he saw agencies making decisions that seemed more motivated by politics than by data, he realized his own faith in the official vetting process was shaken.

That put him in a strange position when his patients asked about the vaccines being developed to prevent Covid-19 and when the researchers testing them asked for his help recruiting Black volunteers.

Its kind of a Catch-22, he said. Hes long been an advocate for the inclusion of communities of color in clinical trials, but he also feels that the agencies overseeing the work are tainted.

A lot of us are on a wait-and-see, trying to get some feeling that the FDA, the CDC, and whoever else is going to approve these vaccines is going to do so based on the science, and not rush it out, he said.

The sentiment wasnt just true for physicians. Francine Maxwell, president of the San Diego branch of the NAACP, said that politicians promises of an effective vaccine by the election has only made her community more suspicious. They dont trust the science behind it, because they feel everyone is doing it to make 45 happy, she said, referring to President Trump.

The response shes hearing from many is to take a step back. Theyre not going to partake when the vaccine comes. Theyre going to wait an additional year. Theyre going to watch and do their own study and see how the data points pan out, she said.

As a past president of the NMA, Hood knew that the organization had in its ranks the kind of expertise that could deeply analyze clinical trial data and so, in August, he helped introduced a resolution to form this task force. There were no objections, McDougle said.

Hood, who is on the task force alongside some epidemiologists and infectious disease specialists, is also hoping to look at the vaccine trial protocols more closely, and if he feels comfortable with one of them, will volunteer to participate himself.

Whether or not their assessment is the same as regulators, said Khadijah Lang, a family physician in Los Angeles and another member of the task force, we will tell our patients what our scientific findings are with full disclosure and full transparency, explaining how we came to our conclusions.

Thats good news to Sandra Crouse Quinn, professor and chair of the University of Marylands family science department. We need sunshine everywhere, we need the pharmaceutical companies to share their data, we need the NMA and any other independent body and the FDA itself to shine the light and, whatever their decision, to say what their rationale is, she said.

Still, shes worried about the acceptance of a Covid-19 vaccine generally and what might happen if the NMAs task forces conclusion differs from federal agencies. How do we explain that so that it doesnt torpedo the credibility of any vaccine? she asked.

Both McDougle and Hood answered that question with a kind of careful optimism. As Hood put it, Hopefully, it will be the same as what the FDA and CDC are saying.

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Black doctors' group creates panel to vet Covid-19 ...

What can we expect from first-generation COVID-19 vaccines?  The Lancet

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What can we expect from first-generation COVID-19 vaccines? - The Lancet