Advisors to the Centers for Disease Control and Prevention voted Tuesday to approve emergency approval of a new COVID-19 vaccine developed by Maryland-based biotechnology company Novavax, making it the fourth immunization to clear that hurdle in the US — and the first to rely on the same trusted technology as some seasonal flu shots.
A Food and Drug Administration advisory panel previously recommended making two doses of Novavax available to Americans ages 18 and older for their first shot, and CDC Director Rochelle Walensky is expected to approve the new vaccine later this week — after which the Biden administration’s recently announced order of 3.2 million Novavax injections will soon be available for the estimated 27 million American adults who are not yet vaccinated.
With clinical trials underway, Novavax also said it hopes to have an updated shot targeting the highly contagious Omicron variant of the virus that will be available in Q4 2022, raising the possibility that a much larger group ” “fully vaccinated” Americans — the vast majority of whom have already received at least two doses of a Pfizer or Moderna mRNA vaccine — may have the opportunity to boost with Novavax at some point.
How effective is the new vaccine?
After reviewing the safety and efficacy data of the two-dose Novavax vaccine, the FDA’s panel of experts last month approved it for emergency use in adults ages 18 and older, recommending that doses be spaced three weeks apart. to keep each other.
In clinical trials conducted before Omicron reached the US, the Novavax vaccine was found to be 90% effective in preventing mild, moderate and severe COVID-19. According to the FDA briefing papers, the most common side effects are injection site pain, fatigue, headache, and myalgia.
However, some FDA experts expressed concern that the vaccine could lead to myocarditis, an inflammation of the heart muscle that has been seen in some patients, especially young men, who have received COVID-19 vaccines. Only four cases of myocarditis were observed among nearly 30,000 vaccine recipients during the Novavax vaccine trials.
“We believe that the totality of the clinical evidence here is not sufficient to establish an overall causal relationship to the vaccine,” Denny Kim, Novavax’s chief safety officer, told the FDA committee, adding that the Company is closely monitoring such cases of myocarditis and is gathering more information. data from its clinical trials and real world use of its vaccine. According to the Washington Post, the vaccine has already been approved in more than 40 countries.
Does the Novavax vaccine protect against new variants of the coronavirus?
Another concern raised by some members of the FDA committee is that the Novavax vaccine was designed to target the original strain of the coronavirus, and little data is currently available on how it works against Omicron and its sub-variants, which are now proliferating. fast across the US
“One challenge is that the trial occurred before the more transmissible Delta and Omicron variants, so it’s probably safe to assume that the effectiveness is slightly lower given the high infectivity of these current variants,” says Dr. Lucy McBride, a Yahoo News medical officer. , said after the FDA’s decision.
Novavax chief medical officer Filip Dubovsky admitted the company does not yet have efficacy data against Omicron or other recent mutations, but he said the vaccine will likely protect against the new variants as well. “The fact is that we have no efficacy data against Omicron. What we do have is a technology that we think generates a broad immune response, demonstrated against a wide range of variants,” Dubovsky said.
A study published in preprint form shortly before Tuesday’s CDC meeting found that three doses of Novavax induced neutralizing antibodies against both Omicron’s parent strain (BA.1) and its even more transmissible subvariants (BA.4 and BA.5) and against three mRNA recordings.
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,” she told Yahoo News.
While Novavax is currently only seeking emergency approval for the primary series of its vaccine, the company has said it plans to seek more extensive approval for the injection’s use in adolescents and as a booster in the future.
How is the Novavax vaccine different from other COVID vaccines?
The Novavax vaccine uses an older and more conventional technology called a recombinant protein, which has been used in other vaccines for the flu, shingles, human papillomavirus (HPV), and hepatitis B.
The mRNA vaccines, such as those manufactured by Pfizer and Moderna, rely on messenger RNA to instruct human cells to make copies of the COVID-19 spike protein, the part of the virus that helps it attach to cells .
In contrast, Novavax vaccine technology produces copies of the virus’s spike protein outside of the human body. These lab-created spike copies, which cannot replicate or cause COVID, are then inserted into the body in a nanoparticle made of a lipid. The body then produces an immune response that helps protect against the virus. In addition, the Novavax vaccine uses an ingredient called an adjuvant that helps generate a broader immune response against the virus.
Following the FDA committee vote in June, some members said the new vaccine provided a valuable tool for determining how the various COVID-19 immunizations fare over the long term.
“I see this as an opportunity to vaccinate people with a protein vaccine on a large scale and to compare it to mRNA vaccines, which is a relatively new technology,” said Dr. Jay Portnoy, a committee member. “The vaccine deserves a chance to be given and studied and used by individuals who want to use this vaccine.”
Will Novavax convince some unvaccinated Americans to roll up their sleeves?
Possibly – but the change is probably insignificant.
In May, unvaccinated Americans were still 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. She also tend to be poorer And more rural than vaccinated Americans.
Unvaccinated Americans regularly tell pollsters that one of the reasons they haven’t gotten vaccinated is that they’re suspicious of mRNA vaccines (although both Moderna and Pfizer have proven to be some of the safest shots ever, with billions of doses administered worldwide).
On Tuesday, Novavax representatives said their more traditional technology would help expand U.S. vaccination efforts by addressing these concerns.
But according to a Morning Consult poll, only 28% of unvaccinated US adults said they considered protein-based injections like Novavax safe — more than the 17% who said the same about mRNA vaccines, but hardly a tidbit.
A whopping 77% of unvaccinated Americans still said they wouldn’t get a protein-based COVID shot if it were authorized in the US. Only 10% said they “probably” or “definitely” would.
