Councilors at the Centers for Disease Control and Prevention voted Tuesday to approve emergency authorization for a new COVID-19 vaccine developed by Maryland biotech company Novavax, making it the fourth immunization to clear that hurdle. in the United States – and the first to rely on the United States. the same familiar technology as some seasonal flu shots.
An advisory panel at the Food and Drug Administration has previously recommended making two doses of Novavax available to Americans 18 and older for their initial inoculation, and CDC Director Rochelle Walensky is expected to to sign the new vaccine later this week – after the Biden administration. recently announced order of 3.2 million Novavax shots will soon become available for the estimated 27 million American adults who remain unvaccinated.
With clinical trials underway, Novavax also said it hopes to have an updated shot targeting the highly contagious Omicron variant of the virus available in the fourth quarter of 2022, raising the possibility that a much larger group of Americans “will be fully vaccinated ” – the vast majority. of whom have already received at least two doses of an mRNA vaccine from Pfizer or Moderna – may someday have the option of boosting with Novavax.
How effective is the new vaccine?
After reviewing safety and efficacy data on the two-dose Novavax vaccine, the FDA’s panel of experts approved it last month for emergency use in adults 18 and older, recommending that the doses are spaced three weeks apart.
In clinical trials conducted before Omicron arrived in the United States, the Novavax vaccine was found to be 90% effective in preventing mild, moderate and severe COVID-19. According to FDA briefing documentsThe most common side effects include pain at the injection site, fatigue, headache, and muscle pain.
Some FDA experts, however, have raised concerns that the vaccine may lead to myocarditis, an inflammation of the heart muscle that has been observed in some patients, especially young people, who have received COVID- 19. During the Novavax vaccination trials, among almost 30,000 vaccine recipients, right four cases of myocarditis were observed.
“We believe that the totality of the clinical evidence here is not sufficient to establish a general causal relationship with the vaccine,” Novavax chief safety officer Denny Kim told the FDA committee, adding that the company closely monitors such cases of myocarditis and gathering more. data from their clinical trials as well as the actual use of their vaccine. According to the Washington Postthe vaccine is already authorized in more than 40 countries.
Does the Novavax vaccine protect against new variants of the coronavirus?
Another concern that has been raised by some FDA committee members is that the Novavax vaccine was designed to target the original strain of coronavirus, and there is currently little data available on how it fares against Omicron and its subvariants, which are spreading now. quickly across the United States
“One challenge is that the trial occurred before the more transmissible variants Delta and Omicron, so it is probably safe to assume that the effectiveness is somewhat lower given the high contagiousness of these current variants,” Dr. Lucy McBride , a Yahoo News medical contributor. , he said after the FDA decision.
Filip Dubovsky, medical director of Novavax, admitted that the company does not yet have efficacy data against Omicron or other recent mutations, but said that its vaccine is likely to protect against the new variants as well. “It is true that we do not have efficacy data against Omicron. What we have is a technology that we think generates a broad immune response, demonstrated against a wide range of variants,” said Dubovsky.
A study published in preprint form just before Tuesday’s CDC meeting found that three doses of Novavax induced neutralizing antibodies against the original Omicron strain (BA.1) and its even more transmissible subvariants (BA.4 and BA.5) as well as three mRNA hits.
McBride said the new vaccine will be an important tool in continuing to fight the virus. “It’s important to remember that any vaccine is better than no vaccine, especially when it comes to high-risk individuals,” he told Yahoo News.
Although Novavax only sought emergency approval for the primary series of its vaccine, the company said plans to seek extended authorization in the future for the use of the shot in adolescents and as a booster.
How is the Novavax vaccine different from other COVID vaccines?
The Novavax vaccine uses an older, more conventional technology called a recombinant protein, which has been used in other vaccines targeting influenza, herpes zoster, human papillomavirus (HPV) and hepatitis B.
mRNA vaccines, such as those manufactured by Pfizer and Moderna, rely on messenger RNA to instruct human cells to produce copies of the spike protein of COVID-19, which is the part of the virus that l ‘helps to attack the cells.
U The Novavax vaccination technology, instead, produces copies of the spike protein of the virus outside the human body. These laboratory-made spiked copies, which cannot replicate or cause COVID, are then inserted into the body in a nanoparticle made of a lipid. Then the body produces an immune response that helps protect against the virus. In addition, the Novavax vaccine uses an ingredient called an adjuvant, which helps generate a broader immune response against the virus.
After the FDA committee’s vote in June, some members said the new vaccine offers a valuable means of determining how different COVID-19 inoculations compare over the long term.
“I see this as an opportunity to widely vaccinate people with a protein vaccine and compare it with mRNA vaccines, which are relatively new technology,” said Dr. Jay Portnoy, a member of the committee. “The vaccine deserves the opportunity to be given and studied and used by people who want to use this vaccine.”
Will Novavax get some unvaccinated Americans to roll up their sleeves?
Possibly – but the change is likely to be negligible.
In May, unvaccinated Americans were also 3.5 times more likely to be hospitalized with COVID than their vaccinated peers, according to CDC data presented Tuesday — and nine times more likely to die from the disease. They too tend to be poorer and more rural than vaccinated Americans.
Unvaccinated Americans regularly tell polls that one reason they are not vaccinated is that they are suspicious of mRNA vaccines (even though Moderna and Pfizer have shown them to be some of the safest inoculations ever, with billions of doses administered worldwide).
On Tuesday, Novavax representatives said their more traditional technology would help expand the U.S. vaccination effort by eliminating those concerns.
But according to Morning Consulting surveyonly 28% of unvaccinated American adults said they saw protein-based shots like Novavax as safe — more than the 17% who said the same about mRNA vaccines, but just a groundswell.
A full 77% of unvaccinated Americans said they would not receive a protein-based COVID vaccine if it were authorized in the U.S. Only 10% said they would “probably” or “definitely.”