Risk of coronavirus vaccine moving too fast

The scientific competition for coronavirus vaccines is progressing at record speed. To get the most out of the results, some patience is required to transform successful clinical products into real progress.

Important reason: When a vaccine is obtained relatively quickly, the next big challenge is to balance the need to get the vaccine into the hands of people and the need to continue working on other more effective solutions.

Where it stands: Eight potential vaccines are in late-stage clinical trials. The first one will be submitted to the FDA for review as early as October or November, and several may be followed within a few more months.

• The FDA has already set the standard for potential vaccines. They must be safe and should reduce the likelihood of moderate to severe infection by at least 50%.
• It’s a relatively modest bar, but experts say it’s especially suitable in an emergency.

But fear An understandable desire to inject a safe and effective vaccine into people’s veins as soon as possible can make it difficult to obtain a better or more targeted vaccine.

• “My concern is I want to make it correct even for the first time [authorize] Natalie Dean, a Florida biostatistician who specializes in the design of clinical trials for vaccines, said:

How to use: Coronaviruses have been shown to affect different people in different ways. Therefore, ideally, we want to know how effective each vaccine is for people with the most important risk factors.

• “We may not have much of it Come out of these trials. Certainly they do not have the ability to deal with the impacts inherent in these subgroups. “
• “People over the age of 65 should not receive this vaccine if there is not enough data in the group over the age of 65. Vaccine expert Paul Offit said. Recent conversation with scientist Eric Topol..
• FDA For evidence of how well each vaccine works across the population, it’s a question their clinical trials are set to answer.

What they are saying: According to experts, one of the most important things regulators and vaccine developers can do right now is to generate as much data as possible, even when clinical trials are in progress.

• They will not have the opportunity to conduct more clinical trials again just to study how the vaccine works for a smaller group of people. Therefore, any questions that need to be answered in the future should be answered with today’s data.
• “This is our chance to learn if something works,” Dean said. “You can’t go back.”

Yes, but: Pfizer and Moderna, which are developing two key candidates, each enrolled about 30,000 people in the trial, but said they would make a preliminary analysis with results of less than 50 people.

• If these results are strong enough, the trial may end prematurely.
• Also, having one effective vaccine makes it difficult to maintain other placebo-controlled trials. According to Dean, researchers face an ethical dilemma about whether to continue taking placebo, and if they think they only need to get the vaccine from their doctor, they are less likely to enroll in a clinical trial and placebo. You are less likely to take risks.

Opposite side: The regulatory process can help some of this, along with some logistical hurdles that make vaccine distribution very difficult.

• Once the first vaccine is approved, only a few doses will be prepared. If the second vaccine arrives a little later and turns out to be very effective, you have time to adjust.
• Some of the key candidates require two shots and some need to be stored at temperatures as low as -20 degrees Fahrenheit. Slightly less effective, but noisy vaccines may also be worth the trade-off, at least for some patients.

Big picture: All of these are issues that need to be managed in a historically fast process. They are not prosecutions for moving fast. They have good problems in many ways.

• “For example, it would be great if we had two to five safe and effective vaccines,” said Dan Barauchi, director of the Harvard University Virology and Vaccine Research Center. Told. “If multiple vaccines show safety and efficacy, we really welcome the results.”