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.
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.
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.
This summer, Jonathan Penman, 24, a college student at the University of Nebraska Omaha, enrolled in a clinical trial of an experimental vaccine for COVID-19.
The virus, he said, was a wake-up call.
I did the vaccine trial because I have a couple of grandmothers who live at our familys home, and my mom works in a preschool, Penman told Healthline. There are people close to me who are susceptible to the virus.
Penman is a participant in the phase 3 trial of mRNA-1273, a vaccine candidate from Moderna, a pharmaceutical company in Cambridge, Massachusetts.
Penman had to drive only a few minutes from his apartment in Omaha to take part in the trial at Meridian Clinical Research.
He received the second of two vaccine injections 2 weeks ago.
I was the first one in the Omaha area to do this trial, he said. So far, so good. Im a little tired from the second injection. Theres a little malaise, but thats about it.
Penman thinks that no matter what happens, he made the right decision.
I think its certainly possible that this could save my life. But we, of course, have no way of knowing, he said.
Penman is grateful that his girlfriend, Morgan, and his friends were supportive of his decision to enter the trial.
I ran this by my girlfriend, who is in nursing school, and she was like, Yeah, if you think you should, do it, go for it, he said.
We have had lot of discussions about this. A few people we know and in my family are anti-vaccine. So, it is a conflict, but not anything major, he added.
Penman said he has friends whove had COVID-19.
I have encouraged people on my Facebook page to do the trial because its the right thing to do. I also encourage them to please wear a mask, he said.
Penman said that thankfully, no one close to him has died from the virus.
I have no idea if I have been exposed or not, he said. But as part of the trial, they have done the swabs. Had I been exposed, that would have showed up there.
The first COVID-19 test he took was before the vaccination, just to make sure he didnt have it.
It came back negative, so I took the first shot, he said. They did my vital signs, it was all good. Then a month later, we did the same thing, and again it was negative.
Penman said the trial wasnt intrusive. But he checked it out before he went through with it.
I Googled it, and the whole concept of the trial works. It makes sense, he said. Its not just a typical vaccination. It attacks the RNA and DNA structure of the virus. That is serious bioengineering. Thats pretty cool.
Moderna is deploying its so-called mRNA platform to develop its vaccine.
While most vaccines use injected viruses to initiate an antibody response, Modernas technology uses viral genetic material RNA to produce the antigens that allow the body to learn to respond to the novel coronavirus.
Moderna is testing to see if its vaccine can help the immune system produce effective antibodies against the virus so that, in case of infection, the virus doesnt cause illness.
As of September 11, more than 23,000 people were enrolled in Modernas phase 3 trial.
All participants will be given an injection half of them with the vaccine, half of them with a placebo. Each group is given a second injection 28 days later.
The total participant enrollment plan for the trial is 30,000.
Why has Moderna been able to make it to a phase 3 trial with relative speed compared with some of the larger U.S. pharmaceutical companies?
Our mRNA platform was already built. It gave us speed, Ray Jordan, Modernas chief corporate affairs officer, told Healthline.
We began making doses for 30,000 participants when we were still in a phase 1 trial, Jordan said. It looked like it was not smart fiscal management. But you take that risk so you can move that much more rapidly.
Jordan explained that the company has been working on vaccines using this technology for a decade. The company has nine vaccine candidates in development against everything from respiratory infections to infections transmitted from mother to baby.
Jordan noted that more than 1,900 participants have been enrolled in Modernas infectious disease vaccine trials in the United States, Europe, and Australia. These are trials other than the one for the novel coronavirus.
People say that we got the virus into the clinic in 63 days. But its really been 10 years and 63 days, Jordan said.
When it comes to the development of a COVID-19 vaccine, no one knows for sure what will happen in the coming months or even years.
But theres increasing though guarded optimism in the scientific community that there will be a vaccine or more than one thats effective.
President Trump has said he wants to develop a vaccine as soon as possible, even if the phase 3 trials arent completed. In early August, Trump said he was optimistic that a vaccine would be ready by Election Day on November 3.
Late last month, Dr. Stephen Hahn, the commissioner of the Food and Drug Administration (FDA), said his agency could consider emergency use authorization or approval for a COVID-19 vaccine before phase 3 trials are complete.
But the chief executive officers at nine of the largest Western pharmaceutical companies with a vaccine being studied wrote a letter pledging that in their efforts to develop a COVID-19 vaccine, they wont take shortcuts and will adhere to the scientific process.
We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles, the pledge reads.
The executives who signed the pledge are from Moderna, AstraZeneca, BioNTech, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson, and Merck.
Explaining why they wrote the letter, Pfizer CEO Albert Bourla, DVM, PhD, told NBC News, We saw it as critical to come out and reiterate our commitment that we will develop our products, our vaccines, using the highest ethical standards and the most scientific processes.
COVID-19 vaccine clinical trials are also being run by such companies as CanSino Biologics, Inovio, Sinovac, Gamaleya Research Institute of Epidemiology and Microbiology, CureVac, and Clover Biopharmaceuticals.
Russia and China are also developing vaccines.
Penman is optimistic about the possibilities of having a COVID-19 vaccine relatively soon.
Meanwhile, his eyes are firmly focused on the future.
Penman wants to get a federal emergency management position. He plans to join the National Guard and is trying to get a commission through the Reserve Officers Training Corps (ROTC).
Im going to try to get an officer position in the government. I would like to work in Homeland Security. But honestly, whatever is available, he said.
Penman has developed an interest in the concept of government intervention and public health since he decided to enroll in the clinical trial.
Im just curious about it, he said. Will the vaccine be mandatory? And what does that say about civil liberties? To what extent will government make it mandatory?
Penman said he has been reading lately about how the United States is one of the only countries where people are protesting the wearing of masks.
Its interesting. We are pretty defensive in this country about our liberties, he said.
But I encourage people to do the right thing. I encourage people to wear a mask. I have been exposed. Ive had friends around me who have gotten it. But some people just dont take it seriously.
The Microsoft cofounder and cochair of the Bill & Melinda Gates Foundation is spending much of his prodigious fortune trying to change the worldby tackling the diseases that hurt the poorest of the poor. But this year, a generations worth of progress is being threatened by a once-in a-century pandemic. Can an all-in bet on science and innovation set us back on course?
This edited Q&A has been condensed for space and clarity.
Since 2017, the Bill & Melinda Gates Foundation has issued an annual scorecard, called the Goalkeepers Report, on how were doing in the fight against global poverty and disease. In the latest assessment, you began with words Im guessing youve never uttered before: This progress has now stopped.
Gates: Yes, the United Nations developed these goals for humanity, which are about basic needs: getting rid of extreme poverty, providing access to education and health care. And so that creates a framework for us to do a report card every year and try to highlight the countries that are doing things wellwe call them exemplarsso that we can get others to adopt best practices. The visibility of gradual progress is very low: Since 2000, weve cut childhood death rates in half, for example, but the progress is mostly invisible to people.
This years report, however, is quite a contrast. Due to the direct effects of the pandemic, in terms of the deaths it has caused, but also due to its gigantic indirect effects on fragile health systems in the developing countries, weve regressed. So routine immunization rates, which weve worked to raise to 84% over the last 25 years, are down 14 percentage points in the past year. The pandemic has pushed almost 37million more people into extreme povertyuntil 2020, that number had been going down every year for two decades. So the call here is to say, Hey, weve got to bring this pandemic to an end. And then we have to work to catch up and get back to where we were at the start of 2020 on things like vaccination and education, so that we can resume that positive trajectory.
One opportunity for optimism, perhaps, is what seems to be a new wave of collaboration among companies in the wake of COVID-19. Is this new sense of shared purpose in the private sector real?
Well, the pharma industry is certainly stepping up to play their role. A lot of the big companies are agreeing to put their best people on both therapeutics and vaccines, so thats pretty spectacular. And thats why we have six vaccine constructs [methods of building vaccine], each of which could possibly be through an FDA Phase III clinical trial and receive an emergency-use license by early next year. The likelihood is that at least two, three, or four of those will probably prove to be both safe and efficacious. Then well be faced with the challenge of scaling up manufacturing to a completely unheard-of level. The form of cooperation thats never been done before is having a company that did not invent the vaccine provide its factories so that they can scale up that manufacture. Serum Institute of India, for example, has deals with AstraZeneca and [Maryland-based vaccine maker] Novavax. So were facilitating those pairings because the Indian manufacturers are much higher volume. Theyve got 5,000-liter tanks and huge built-in extra capacity.
The Gates Foundation has also invested heavily in possible medicines to treat COVID-19. What progress are you seeing there?
So far, in the way of therapeutics, theres dexamethasone [a steroid hormone first approved by the FDA in 1958], which is the only treatment that has significant impact. Even [Gilead Sciences antiviral agent] remdesivir, right now, is still showing pretty modest results. But theres a pipeline of things being tested, including a number of monoclonal antibodies [lab-produced proteins that act like human antibodies, homing in on specific targets], which have the best chance of having fairly dramatic outcomes. We dont know for sure, but the cure rates could be very high, like 70% or 80%. Some of that data will start being published in the next month or two. The Gates Foundation reserved capacity at a factory owned by Fujifilm to manufacture an antibody product. We have to provide them with the thing by sometime in October, so were scrambling. If the antibodies dont work out or if we dont have the right ones, then well lose some of that money. But thats fine, because the potential impact of having that capacity, which is significant, would let us get it out to developing countries without having just the rich countries take all that capacity just for their usage.
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Peoples attitudes towards masks and the vaccine, will, in a concrete way, help determine how quickly we bring this pandemic to an end.
The Gates Foundationin a similar vein as BARDA, the U.S. governments Biomedical Advanced Research and Development Authorityde-risks a lot of the riskier investments that private companies make for the common good. How else can governments encourage innovation on the more revolutionary fronts of science and medicine?
The U.S. is exemplary in this. Weve got $42billion a year of NIH money that often lays the research foundation for understanding the biology so that the product innovation can go on and companies can then develop medicines based on that biology. There is all sorts of friction about what drug prices should be, which is a big, complex topic, but the U.S. systemin terms of creating high-paying jobs and leading companies here and in getting the availability of new medicines to the U.S. very quicklythats working pretty well.
You mentioned drug pricing. Can these COVID-19 vaccines and medicines be made cheaply enough that the world can afford them?
I have a regular discussion with the pharma CEOs. Their response to the pandemic and this great work that pharma people are doing has reminded many of their capacities and how they can be helpful to the worldas opposed to the industry being viewed as kind of selfish and uncooperative. In the last big, big health crisis we had, when the HIV epidemic came along, the industry didnt have a willingness initially to do tiered pricing, to get the drugs out to the developing countries [at prices they could afford], and they ended up in a lawsuit with former South African President Nelson Mandela. Eventually, they did the right thing. And thats why I think the commitment today by some of these companies to put resources into the vaccine manufacture, and to do it on a nonprofit basis, is pretty valuable.
Its hard enough producing enough safe and effective vaccines against COVID-19. Persuading billionsof people to take them may be harder yet.
The issue is just basic trusthow do people think about vaccines? With all the conspiracy theories out there, you know, weve got a challenge with thatnot just in the developing countries, but everywhere. The most extreme example was where the polio vaccine was said to be a plot to sterilize women in Nigeria in 2003. And sadly, that led to cases spreading to a dozen countries where the disease had been eliminated.That was a huge setback. But there we got the trusted religious leaders to get the message out and give the vaccine to their children, and so, eventually, we overcame that. Today, peoples attitudes towards masks and the vaccine, will, in a concrete way, help determine how quickly we bring this pandemic to an end.
Speaking of conspiracy theories, there was an insane one floating on social media about youthat you had somehow created this pandemic. Youre arguably the best-known champion of public health on the planet. How do you get past that sort of crazy?
Well, its a new phenomenon. So I cant say I have some great solution or expertise. And even though its so extremeyou could almost say its humorousit is potentially a real problem, particularly when you have some people turning it into a political thing and even talking about taking violent action. So, Im just learning about this. And, Im certainly surprised that the organization thats done more to save lives with vaccines is now being treated as though our goals are kind of the opposite.
The likelihood is that at least two, three, or four [vaccines] will probably prove to be both safe and efficacious.
Strangely, this is happening at a time when vaccine science in general seems to be advancing at breakneck speed. Can the race to create COVID vaccines help us develop one against, say, malaria?
We actually have a concrete project with Moderna to do a malaria vaccine construct using the messenger RNA platform [a method also being used for some COVID vaccine candidates]. That is somewhat interrupted by the pandemic, but it is an approach that we funded. We started backing these mRNA vaccines almost a decade ago. They are very promising and could be used potentially for HIV and tuberculosis as well.
The legendary investor Warren Buffett, who just turned 90, has entrusted much of his own fortune to your foundation. What have you learned from him in your long friendship?
Im talking to Warren actually more regularly this year than at any time during our friendship, which is almost 30 years now. And its because of his ability to look at whats going on in the world and be fascinated and surprised. He and I sit and marvel over the unexpected things that are going on in many frameworks: political, macroeconomic, and in the world at large. He knows so much more about business, and he sees so much. Talking about, Okay, are people buying furniture this year? And the answer is yes, actually its at higher levels than last year. And going through each of his businesseswhere has he seen the demand, and why he thinks that is? Or talking about an Austrian 100-year bond selling at 88 basis pointsand what that means. He hears a little bit from me on the digital realm, or about some of this health-related innovation, particularly related to the pandemic. But, you know, we never run out of things to talk about. He just brings such a sophisticated frameworkand he always has this humility that goes with it, which makes it so much fun because hes having fun. Hes also very careful about what he claims to know. You know, Id rather talk to him about business and the economy than anyone else.
Youre known for clearing time on your calendar for Think Weeks, where you hole up in a cabin, read books, and ponder the world. Why is this so essential?
Adult life is so easy to fill up with activities. The ability to step back and read deeply or think deeply or write up thoughts is largely missing. And so I work hard on my schedule to make sure Im not filling it up with too many things. Its been a little bit easier with no travel this year. So I think of myself as a student where I need almost like a reading period to consolidate my knowledge. It was particularly challenging when I was CEO of Microsoft. Eventually, I got to two weeks a year that I was setting aside. Since I retired from Microsoft in 2008, I dont have to do it necessarily as one block, a week at a time, but I do set aside lots of days, and then I say, Did I write the memo that I intended to write? The act of writingwhen you try to explain it to someone elseis where you really are forced to think things through and not be sloppy in your thinking.
Newsletter-Red-Line-15
(1) Black check: Since 1994, the Bill & Melinda Gates -Foundation has awarded $54.8billion in grants (through Q4 2019).
(2) Projected change in people earning less than $1.90 per day (intl. poverty line):2018: -1.2%2019: -1.5%2020: +7.1%Source: Gates Foundation
(3)Fast lane for meds: In March, the Gates Foundation partnered with the U.K. foundation Wellcome and Mastercard in a COVID-19 Therapeutics Accelerator designed to speed upand scale upthe development of treatments.
(4) PR nightmare: In 1998, 39 multinational drugmakers sued the South African government (and Mandela, its former President) for circumventing patent protections on exorbitantly priced medicines for HIV/AIDS. The pharma companies would ultimately lose their legal battleand much of their reputation.
(5) Rich and poor alike: AstraZeneca and Johnson & Johnson have promised to deliver vaccine on a nonprofit basis through the pandemic. More than 170 nations have signed on to a GAVI-led compact called the COVAX Facility, whose aim isto ensure thatvaccines are distributed equitably around the world.
Death averted, compared with a no-vaccine scenario:When a vaccine is distributed to high-income countries first: 33%When a vaccine is distributed to countries according to their population size: 61%Source: Gates Foundation
(6)Ending a scourge: The Gates Foundation has committed $5.5billion to the global polio eradication effort.
(7)Give it away now: In addition to committing 10million shares of Berkshire Hathaway stock (in annual payments) to the Gates Foundation, Buffett joined with Bill and Melinda to launch the Giving Pledge, an effort to encourage fellow billionaires to commit to giving the majority of their wealth to philanthropy.
(8)Long-lasting bond: In June, the Austrian government issued more than $2 billion worth of century bonds, yielding just 0.88%. One hundred years may seem like a long time to wait for little gainbut with much of the world looking for safety, this auction was oversubscribed.
A version of this article appears in theOctober 2020 issueofFortunewith the headline The Conversation: Bill Gates.
This story was originally featured on Fortune.com
A professional society of Black physicians has formed a task force to assess COVID-19 vaccines and treatments, in light of concerns that federal agencies may approve vaccines and drugs without adequate proof that they work, Stat News reported.
The National Medical Association (NMA), which represents Black physicians and health professionals in the U.S., formed the task force following recent, controversial actions taken by both the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). For instance, the CDC initially issued guidance that close contacts of infected people should only get tested for COVID-19 if they show symptoms, even though asymptomatic people can spread the virus; the FDA authorized the widespread use of plasma therapy for COVID-19 with little proof it works, and recently revoked its emergency authorization of hydroxychloroquine after patients developed serious heart, kidney and liver problems, according to the agency's website.
"There is a concern that some of the recent decisions by the Food and Drug Administration have been unduly influenced by politicians," Dr. Leon McDougle, a family physician and president of the National Medical Association, told Stat News. In addition, President Donald Trump has teased that a COVID-19 vaccine could be available before November 3, raising concerns that the vaccine approval process might be dangerously rushed before data shows the vaccine works, according to The New York Times. To address this growing uncertainty, the NMA task force plans to double-check that any approved drug or vaccine is truly safe and effective.
Related: 20 of the worst epidemics and pandemics in history
"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 told Stat News. "What we've seen in terms of political interference in the FDA and CDC has really undermined what little trust the Black community had," added emergency physician Dr. Uch Blackstock, the founder and CEO of the consulting firm Advancing Health Equity, who is not a member of NMA.
In addition to reviewing the safety and effectiveness of approved vaccines and drugs, the task force will look at whether clinical trial participants accurately represent the demographics of the broader U.S. population, according to Stat News. If the FDA approves a drug or vaccine without releasing all the relevant data, McDougle told Stat News that he hopes that NMA members involved with federal agencies could still get access to those reports.
While some experts agree that the task force is greatly needed, others worry that it could undermine acceptance of COVID-19 vaccines, in general, if the NMA's assessments clash with the official guidance of the CDC and FDA.
The thought is that too much uncertainty could deter people from getting any approved vaccine, even if the panel confirms it's safe. Read the full story at Stat News.
Originally published on Live Science.
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The federal government is spending millions to accelerate the production of a coronavirus vaccine. Though the rushed process may produce an ineffective vaccine, the benefits of mandating the vaccine outweigh the potential risks.
In July, the federal government announced it will invest over $2 billion in grants to companies that are trying to manufacture a vaccine or treatment for COVID-19. The grants went to companies such as Regeneron, which has had success in developing treatment drugs for Ebola, and Novavax, which has tried to produce many vaccines but has failed at getting the Food and Drug Administrations approval for any.
The government is investing so much money into these companies so that, when one of these manufacturers develops a vaccine that the FDA approves, it doesnt have to wait months for mass quantities of the vaccines to be produced. The government even wants mass quantities to be produced and has committed to buying them even before knowing the vaccines are effective, which is a risky strategy.
The rushed process for vaccine development, testing and approval has many Americansworried. But most of the vaccines that these companies are producing are completely harmless, showing your immune system something that looks like the virus to prepare your body to fight the actual thing.
The vaccines being developed are also modeled after knowledge of past vaccines that have been developed and have proven effective. The development and testing processes, although accelerated, are similar to ones implemented in the past for other viruses and are familiar to scientists and doctors.
Any vaccines that are developed in this shortened timeline will likely be pretty safe because that is one of the main concerns, said Brittany Kmush, an assistant professor of public health at Syracuse University who specializes in the study of vaccines, global health and infectious diseases. (Pharmaceutical companies) are doing a good job of evaluating safety and really looking at the short-term safety profiles, she said.
Though a vaccine for COVID-19 is likely to be very safe, it may not be entirely effective. If a vaccine is rushed but proves ineffective once given to people, or if its only effective for a limited amount of time, there are consequences.
If an ineffective vaccine is given to students, and they believe it works, the students put their guards down. If this does happen, people will likely become less cautious about practicing social distancing and wearing masks, which will likely cause another wave of COVID-19 infections and deaths.
However, this negative possibility does not outweigh the pros of mandating a vaccine that may not be entirely effective. If a vaccine does come out and is proven to work, countless lives will be saved. Schools will be able to return to some semblance of normalcy, and COVID-19 will mirror what happens to all deadly viruses once a vaccine or cure is found: the virus will infect fewer people, and the pandemic will tamper off.
Because a vaccine will not have been around for years or decades, there is no way we can know if there are some kind of very rare, long-term side effects, Kmush said. But thats not very likely because they are using the same technology as they used for other vaccines that have been around for decades.
Even with a possible vaccine on the way, students still have the responsibility to ensure that they are continuing to follow guidelines from the Centers for Disease Control and Prevention and practice social distancing until a vaccine is proven safe and effective. A new vaccine could be the first step in allowing students a normal college experience in the spring.Skylar Swart is a sophomore political science major. Her column appears bi-weekly. She can be reached at saswart@syr.edu. She can be followed on Twitter at @SkylarSwart.
Published on September 20, 2020 at 10:34 pm
Safety and efficacy of the Russian COVID-19 vaccine: more information needed Authors' reply The Lancet
