Another promising vaccine, that of Johnson & Johnson

Crushing Covid will require making the most of the different vaccine candidates, which come with their own pros and cons, and adjusting them to stay ahead of viral mutations. All vaccines follow a similar basic approach, placing the spike protein on the surface of the coronavirus in their arms. But Johnson & Johnson’s vaccine takes a slightly different approach to delivery than the vaccines produced by Pfizer and Moderna. (I’m on the board of Pfizer.) Biotech company Novavax is looking for a vaccine candidate with its own special delivery system. All four could be available in the summer, which would mean ample supply.

Americans will wonder which works best? It will be tempting to compare data between tests. But these are not apples to apples; vaccines and data are not the same. And new variants of Covid may require vaccines that offer slightly different layers of protection and target slightly different parts of the virus.

The regulatory process should encourage this type of portfolio diversification, while at the same time allowing adjustments to stay ahead of virus twists. The FDA is working on guidelines to address new variants, which will include a pathway to upgrade vaccines.

The model should be the flu vaccine process. Each year scientists develop the basic components for flu vaccines that are able to target many different strains of the virus. But only the three or four strains that are expected to be most frequent are put into production. The rest stays on the shelf, ready to go into production if the flu takes an unexpected evolutionary turn. The FDA should do the same with Covid.

Second, it is essential to design clinical trials that can be completed in a few months, to avoid possible outbreaks of new variants. It’s fast, but given the current scientific capabilities that might be enough to do the necessary testing.

Take the South African variant known as B1351. Existing trials will be used to establish that current vaccines provide clinical protection against Covid disease. But to demonstrate the newer operating versions of B1351 and current vaccines, the FDA can measure the plasma antibody levels of patients who have recovered from B1351 and set a benchmark for the number of antibodies needed. to neutralize this virus. The FDA can then use these antibody levels as a proxy to assess whether up-to-date vaccines can generate sufficient levels of protection.

This could allow vaccine manufacturers to test new drivers in clinical trials enrolling 300 or 400 patients instead of 40,000, which is a huge cost and time saver. Larger and longer studies can be initiated at the same time, including those followed by vaccinated patients.

The virtue of new vaccines is that they are derived through synthetic processes that use the coronavirus RNA sequence. This means that vaccines are relatively easy to upgrade when new variants appear.

Another priority should be the development of antiviral drugs. We need more tools that work after the core features of how viruses reproduce and that do not depend on proteins directed to the surface of the virus. These medications can continue to be effective even if the virus mutates.

The best support against the widespread transmission of mutant strains remains the same: an audience that takes precautions such as social distancing and masks, combined with a reflective and agile system for vaccine development.

Dr. Gottlieb is a resident member of the American Enterprise Institute and was commissioner of the Food and Drug Administration, 2017-19. Serves on Pfizer and Illumina boards.