Another promising vaccine, this one from Johnson & Johnson

Crushing Covid will require making the most of the various vaccine candidates, who come up with their own pros and cons, and modifying them to stay ahead of viral mutations. The vaccines all follow a similar basic approach, carrying the spike protein found on the surface of the coronavirus. But the Johnson & Johnson vaccine takes a slightly different approach to delivery than the vaccines produced by Pfizer and Moderna. (I’m on Pfizer’s board of directors.) Novavax Biotechnology is pursuing a vaccine candidate with its own special delivery system. All four could be available until the summer, which would mean a wide range.

Will Americans wonder which one works best? It will be tempting to compare the data between samples. But this is not apple in apple; 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 must encourage this type of portfolio diversification, while allowing adjustments to be maintained before viral turns. The FDA is working on guidelines to address new variants, which will include a way to update vaccines.

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

Secondly, it is essential to design clinical trials that can be completed in a few months, in order to avoid potential outbreaks of new variants. It’s fast, but given today’s scientific capabilities, that might be enough time to make the necessary tests.

Take the South African version known as B1351. Existing studies will be used to establish that current vaccines provide clinical protection against Covid disease. But to prove new versions of B1351, as well as current vaccines, the FDA can measure plasma antibody levels in patients who have recovered from B1351 and set a benchmark for the number of antibodies needed to neutralize the virus. . The FDA can then use these antibody levels as a proxy to assess whether the updated vaccines are capable of generating sufficient levels of protection.

This could allow vaccine manufacturers to test new stimulants in clinical trials enrolling 300 or 400 patients, rather than 40,000, which is a huge saving in time and cost. Larger and longer studies can be started at the same time, including those following vaccinated patients.

The virtue of the new vaccines is that they are derived by synthetic processes using the coronavirus RNA sequence. This means that vaccines are relatively simple to update when new variants appear.

Another priority should be the development of antiviral drugs. We need more tools to track the central features of how viruses reproduce and not depend on the targeted proteins found on the surface of the virus. These medicines may remain effective even if the virus moves.

The best backstop against the widespread transmission of mutant strains is the same: an audience that takes precautions such as social distancing and masks – associated with an attentive 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. It serves on the panels of Pfizer and Illumina.