Another promising vaccine, this one from Johnson & Johnson

To crush Covid, the best use will have to be made of the different vaccine candidates, who have their own pros and cons, and they need to adapt to stay ahead of viral mutations. The vaccines all follow a similar basic approach, placing the vein protein found on the surface of the coronavirus in the arms. But the Johnson & Johnson vaccine follows a slightly different approach to delivery than vaccines manufactured by Pfizer and Moderna. (I’m on the board of Pfizer.) The biotechnology company Novavax is looking for a candidate for vaccination with its own special delivery system. All four are possibly available by the summer, which will mean a generous supply.

Americans will wonder which one works best? It would be tempting to compare data between trials. But these are not apples for apples; the vaccines and the data are not all the same. And new variants of Covid can apply vaccines that offer slightly different layers of protection and target slightly different parts of the virus.

The regulatory process should encourage this kind of portfolio diversification, while allowing adjustments to keep up with the twists and turns of the virus. The FDA is working on guidelines to address new variants, which will include a pathway for updating vaccines.

The model should be the flu vaccine process. Scientists annually develop scientists the basic components for flu vaccines that can target many different strains of the virus. But only the three or four strains that are expected to be the most common are put into production. The rest remain on the shelf, ready to be put into production, should the flu unexpectedly turn evolutionary. The FDA should do the same for Covid.

Second, it is essential to design clinical trials that can be completed within a few months to prevent potential outbreaks of new variants. It is fast, but given the scientific capabilities of today, it may be enough time to do the required trials.

Take the South African variant, known as B1351. The existing trials will be used to establish that current vaccines provide clinical protection against Covid’s disease. But to prove that the new versions working on B1351 as well as the current vaccines, the FDA can measure the plasma antibody levels of patients who have recovered from B1351 and establish a measure of the number of antibodies needed to kill the virus neutralize. Then the FDA can use the antibody levels as a power of attorney to evaluate whether updated vaccines can generate adequate levels of protection.

This could enable vaccine manufacturers to test new enhancers in clinical trials enrolling 300 or 400 patients rather than 40,000, resulting in huge cost and time savings. Larger and longer studies can be started at the same time, including studies that follow vaccinated patients.

The virtues of the new vaccines are that they are obtained by synthetic processes using the sequence of the coronavirus’ RNA. This means that the vaccines are relatively simple to update when new variants emerge.

Another priority should be the development of antiviral drugs. We need more tools that are important for the way the viruses repeat and do not depend on proteins found on the virus’ surface. These drugs can remain effective even if the virus changes.

The best backstory against the widespread transmission of mutant strains is still the same: a public that takes precautions such as social distance and masks – coupled with a thoughtful and nimble system for developing vaccines.

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