Another promising vaccine, this one from Johnson & Johnson

To crush Covid, it will be necessary to make the most of the different vaccine candidates, which have their advantages and disadvantages, and to fine-tune them to stay ahead of viral mutations. The vaccines all follow a similar basic approach, harnessing the spike protein found on the surface of the coronavirus. But Johnson & Johnson’s vaccine takes a slightly different approach to the delivery of vaccines produced by Pfizer and Moderna. (I’m a member of the Pfizer board of directors.) Biotech company Novavax is looking for a vaccine candidate with their own special delivery system. All four could be available by summer, which would mean a sufficient supply.

Americans will wonder which one works best? It will be tempting to compare data between trials. But it’s not apples to apples; vaccines and data are not all the same. And newer 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 any twists in the virus. The FDA is working on guidance to deal with new variants, which will include a vaccine update route.

The model should be the influenza vaccination process. Each year, scientists develop the building blocks of influenza vaccines that are able to target many different strains of the virus. But only the three or four strains believed to be the most widespread are put into production. The others remain on the shelves, ready to go into production if the flu takes an unexpected developmental turn. The FDA should do the same for Covid.

Second, it is essential to design clinical trials that can be completed in several months, in order to avoid possible outbreaks of new variants. It’s fast, but given today’s scientific capabilities, it might be enough time to do the required tests.

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 prove that newer versions targeting B1351 work 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 for neutralize this virus. Then the FDA can use these antibody levels as a proxy to assess whether the updated vaccines are able to generate sufficient levels of protection.

This could allow vaccine manufacturers to test new boosters in clinical trials that enroll 300 or 400 patients instead of 40,000, which represents huge savings in time and money. 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 RNA sequence of the coronavirus. 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 tackle the central features of virus replication and that do not depend on targeting proteins found on the virus surface. These drugs may still be effective even if the virus mutates.

The best safety net against the widespread transmission of mutant strains is always the same: an audience that takes precautions like social distancing and masks – paired with a thoughtful and agile system for developing vaccines.

Dr Gottlieb is a resident researcher at the American Enterprise Institute and served as Commissioner of the Food and Drug Administration, 2017-19. He sits on the Boards of Directors of Pfizer and Illumina.