Another promising vaccine, this one from Johnson & Johnson

Smashing 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, putting the peak protein found on the surface of the coronavirus into arms. But the Johnson & Johnson vaccine has a slightly different approach to delivering vaccines produced by Pfizer and Moderna. (I am on the board of Pfizer.) The biotech company Novavax is looking for a vaccine candidate with its own special delivery system. All four may be available in the summer, which means an ample supply.

Americans will wonder which one works best? It will be tempting to compare data between trials. But this is not apples to apples; vaccines and data are not all 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 allowing adjustments to stay ahead of the virus’s twists and turns. The FDA is working on guidelines for dealing with new variants, which will include a path for updating vaccines.

The model should be the flu vaccine process. Every year, scientists develop the basic components of flu vaccines, which are capable of targeting many different strains of the virus. But only the three or four strains expected to be the most prevalent are put into production. The rest is on the shelf, ready to go into production if the flu takes an unexpected evolutionary turn. The FDA must do the same with Covid.

Second, it is essential to design clinical trials that can be completed in several months to avoid potential outbreaks of new variants. It’s fast, but due to today’s scientific resources, it may be enough time to do the necessary tests.

Consider the South African variant known as B1351. Existing tests will be used to establish that current vaccines provide clinical protection against Covid’s disease. But to prove that the new versions targeting B1351 work as well as current vaccines, the FDA can measure plasma levels of antibodies in 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 levels of antibodies as a substitute to assess whether updated vaccines are capable of generating sufficient levels of protection.

This could allow vaccine manufacturers to test new boosters in clinical trials involving 300 or 400 patients instead of 40,000, a huge cost and time savings. Larger and longer studies can be started at the same time, including those that follow 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 easy to update when new variants appear.

Another priority should be the development of antiviral drugs. We need more tools that look for central characteristics of how viruses replicate and do not depend on target proteins found on the surface of the virus. These drugs can remain effective even if the virus mutates.

The best protection against the widespread transmission of mutant strains is still the same: an audience that takes precautions such as social distance and masks – paired with an intelligent and agile system for developing vaccines.

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