A panel of independent advisors to the Food and Drug Administration voted Tuesday for the approval of the Covid vaccine by Novavax for adults aged 18 and over.
One person abstained. Twenty-one of the members of this committee voted for the shot. The FDA will then decide whether to approve the shot for emergency use. This would make it the fourth available coronavirus vaccine in the U.S. The FDA follows often the recommendations of the group.
Novavax’s shot, if it is approved, would be the only Covid vaccine that is protein-based. This formulation is older than those used in Moderna and Pfizer’s mRNA shots. In the past, several protein-based vaccines have been approved by FDA. One was for hepatitis B. Another was for shingles.
Some FDA committee members believe it could appeal to U.S. citizens who have not yet vaccinated.
“Some people may find a protein-based option more convenient in terms of accepting vaccines,” said Dr. Peter Marks at the meeting. He is the director of FDA’s Center for Biologics Evaluation and Research.
According to the Centers for Disease Control and Prevention, one-third of Americans aren’t fully vaccinated for Covid and 22 percent haven’t received any Covid vaccine doses.
Novavax’s vaccine was highly effective in its clinical trial. It reduced the risk of symptomatic Covid in an estimated group of over 30,000 people in Mexico and the U.S. by 90%. The vaccine’s effectiveness against the omicron virus was not determined because it was tested from December 2020 to February 20,21. This was when the dominant coronavirus variant was alpha.
“It’s quite disappointing that there are no data in the Omicron era,” stated Dr. Mark Sawyer of Rady Children’s Hospital San Diego. He said that the data was “very similar to what we have approved in the past for other vaccines.”
In December, the World Health Organization approved Novavax for emergency use. It is also approved in Australia, India, Indonesia and South Korea. Novavax announced Tuesday that 740,000 doses were being administered in the world as of April.
The vaccine can be stored in a refrigerator for up to 6 months. Alternatively, mRNA vaccines need to be kept at below zero temperatures. This makes them more difficult to transport.
Marks stated Tuesday that the U.S. had been able to offer other vaccines for some time, but that “anything that we can do to make people more comfortable accepting these potentially lifesaving medical products (or any other options) is something we feel compelled to do.”
Other experts were skeptical that vaccine-sceptics would view Novavax differently. According to CDC data, the U.S. has already disposed of 82.1 million Covid doses between December 2020 and mid-May — more that 11 percent of federally distributed doses.
Dr. Arthur Reingold from the University of California, Berkeley School of Public Health, said that he is skeptical that many vaccine hesitant people are waiting for the vaccine. He believes that the vaccine will prove to be more effective than other vaccines.
Novavax’s vaccine is composed of two doses that are administered three weeks apart. To stimulate the production antibodies, it uses the spike protein purified from the coronavirus along with an immune-boosting agent called an adjuvant. MRNA vaccines, on the other hand, use a small portion of the coronavirus genome to tell the body to make the spike protein in its own cells. This then triggers the creation of antibodies.
Johnson & Johnson’s Covid vaccine introduces a gene to produce the spike protein in the body through a genetically engineered common virus. The risk of blood clots is why this shot is only available to adults who have refused the other Covid vaccines.
Novavax had its adult trial data since June last year, but there were manufacturing problems that caused delays in the application for U.S. approval. Politico reported that Novavax was unable to consistently check the quality of its vaccine batches. Soon after, the company released a statement stating that it adhered to “strict standards of production” and manufacturing. Novavax applied for authorization in January.
Dr. Goutam S, chair of the FDA’s Vaccines and Related Product Applications review committee, stated Tuesday that Novavax has made changes to its manufacturing process over the years and that it has kept FDA informed about these changes. However, this also means that the vaccine product used during the trials may not be the same one that would be distributed to patients if it was approved.
According to an FDA briefing document, five cases of myocarditis and pericarditis were identified in the Novavax trial within two weeks of vaccination.
The CDC compared this to 1,226 myocarditis reports from 296 million Pfizer or Moderna vaccines between December 2020 and June 2021. Some committee experts said that it may not be fair to compare myocarditis risks across vaccine platforms, as Novavax is not yet distributed as widely.
“It would not be possible to say that it occurs more often with one vaccine platform over another at this stage,” stated Dr. Cody Meissner of Tufts University School of Medicine.