“Shared expectations lead to predictability.”
580. A fourth Covid-19 vaccine has received FDA approval.
Q: What is different about this latest vaccine to be approved in the United States?
A: On July 20, The New York Times published an article that announced the FDA approval of a fourth Covid-19 vaccine. When “Operation Warp Speed” was initiated under the Trump administration, Novavax, a Maryland pharmaceutical company had begun developing a Covid-19 vaccine using the long-standing traditional method of using a protein-based sample of the surface of the virus to provoke an immune response with these nanoparticles. This traditional method has been used in the past to develop vaccines against the seasonal flu, polio and other viral diseases. The Trump administration paid in advance for millions of doses to be manufactured, hopefully after the vaccine could be shown to be effective.
Shortly after this action, a new method of developing vaccines was found to produce results far more rapidly – the so-called mRNA process. If this more effective manufacturing process had remained obscure, the Novavax vaccine and others like it would only now be emerging as the first vaccines to be effective against Covid-19. One can only imagine how widespread the disease would have become if the previous three mRNA vaccines had not been available!
While Novavax doses are expected to play a limited role in the country’s current immunization campaign, having another approved tool to fight the virus as it continues to mutate is a positive development.
With two doses spaced three weeks apart, the Novavax vaccine has demonstrated an overall efficacy of 90.4 percent, which is on par with the vaccines made by Pfizer and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed an efficacy of 100 percent at preventing moderate or severe disease.
The vaccine was tested before the emergence of the Omicron variant, which has sharply reduced the effectiveness of other authorized vaccines in preventing infections. However, Novavax is developing new versions of its vaccine that target Omicron and its highly contagious subvariants. Preliminary data from laboratory and animal studies indicate that a booster shot aimed at the BA.1 subvariant, which preceded the current highly infectious BA.5 version, generates strong immune responses to the virus. The company says it expects to have results from a clinical trial of that shot in September, with doses ready in the last three months of the year.
Trials have also shown that Novavax’s shot works well as a booster, and the company is expected soon to seek authorization for it to be used that way. But the C.D.C. recommended that it now be used as an option for adults as their first vaccination against the coronavirus.
Novavax is hoping its shot will appeal to the millions of people who have so far declined to be vaccinated, perhaps because they are wary of the technology behind the mRNA vaccines. About 22% of the people in the U.S. have not received a single Covid vaccine dose.
Opinion 3. Even the experts are becoming complacent.
Officials in Los Angeles say earlier in July, they plan to reinstate a countywide indoor mask mandate as early as the end of this month. Barbara Ferrer, the public health director in the county, said that even a slight increase in masking would help slow transmission of the virus. I’m like everyone else: I hate wearing that mask. But more than that, I hate the idea that I might accidentally transmit to somebody else,” Ms. Ferrer said. “That’s my biggest fear — that we’re so anxious to be done with this virus that we’re getting complacent.”
