Trumpery

Donald Trump hinted that he could have an “October surprise” in a SARS-CoV-2 vaccine. That isn’t going to happen. The closest is Pfizer’s announcement that it may apply for emergency authorization for its vaccine before the end of November. But, of course, that’s after the election.

The pharmaceutical companies, fortunately, are more interested in preserving their credibility than in currying Trump’s favor. Perhaps they have calculated that Trump is unlikely to win a second term.

ProPublica has a long article on how vaccines are approved. If you want the whole story, check it out. Here’s a tl;dr that’s more like a checklist.

Emergency use authorization (EUA), the fastest way to get a vaccine approved by the FDA, requires three milestones:

1. A clinical trial must observe enough infections to demonstrate that the vaccine is better than a placebo.
2. Data from the trial must be part of an application to the Food and Drug Administration. The company could apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an EUA, which requires less.
3. The FDA reviews the data and decides whether the vaccine is ready for wide use. That could take several weeks to a month.

In the trials, some people receive vaccine and some a placebo. Nobody knows which is which until the results are analyzed. The companies determine interim checkpoints at which they analyze the numbers of people in the trial who contract covid naturally. Pfizer’s first checkpoint is at 32 cases. They have not made public how many cases they have observed so far. Estimates for when they will observe 32 infections are around the end of October or early in November. The date depends on how effective the vaccine is. Pfizer has four checkpoints altogether. If the vaccine were spectacularly successful or damaging, the trial would be stopped.

One person in the AstraZeneca trial had a bad reaction – we don’t know if it was from the vaccine – and that trial has been suspended to look into that reaction. Moderna thinks they may have early results in November, and Johnson & Johnson is just beginning a trial.

All the companies likely have their applications to the FDA written up, ready to drop the results in and send off. The paperwork is considerable – look at Pfizer’s clinical trial plan to get an idea of what is needed.

An EUA allows the use of the vaccine for the duration of the emergency – the pandemic we are in now. Full approval would allow the sale of the vaccine forever. An EUA can be issued more quickly than full approval, but the FDA has higher standards than usual for a SARS-CoV-2 vaccine; it wants at least two months of monitoring trial participants after their second shot. That may take longer than November. Safety is important for a vaccine that will be given to nearly everyone.

The FDA then has a multi-step review process. Not only the clinical trial results, but also the manufacturing facilities must be checked out. It then presents its assessment to an external review committee in a public meeting. The review committee then votes on whether to accept the FDA’s recommendation, and the FDA makes a final decision.

Warning signs are if steps are changed midstream or skipped. These bullets are directly from the ProPublica article.

• If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
• If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
• If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Dr. Peter Marks, director of the Center for Biologics Evaluation and Research. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’s decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
• If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.

Once a vaccine is approved, doses must be prepared and distributed. This will be an enormous undertaking and can be expected to run into glitches. Full distribution may take a year or more. Until then, we must continue to wear masks, distance ourselves, and limit gatherings. If Joe Biden is elected president, we will have more testing and a serious approach to public health, so we may not have to wait until most of us are vaccinated to lift many of the restrictions.

Cross-posted to Nuclear Diner

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