Posted on 06/07/2022 12:37:50 PM PDT by American Number 181269513
Novavax’s two-dose dose Covid-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration authorization on Tuesday.
The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention to recommend authorization of the shot for use in the U.S. after an all-day public meeting in which they weighed safety and effectiveness data. The FDA usually follows the committee’s recommendations, though it is not obligated to do so. The agency could clear Novavax’s vaccine for distribution in the U.S. as soon as this week.
The Centers for Disease Control Prevention would still need to sign off on the shots before pharmacies and other health-care providers can start administering them to people.
Novavax’s shot would be the fourth Covid vaccine authorized for use in the U.S. The Maryland biotech company’s shots are based on protein technology that’s been in use for decades in vaccines against hepatitis B and HPV. The technology differs from Pfizer and Moderna’s shots, which were the first ones using messenger RNA technology to receive FDA approval.
Dr. Peter Marks, who leads the FDA office responsible for reviewing vaccine safety and effectiveness, said Novavax’s vaccine would potentially appeal to people who have not gotten immunized yet because they would rather receive a shot that is not based on the mRNA technology used by Pfizer and Moderna. Though Johnson & Johnson’s shot is also available, the CDC has restricted its use due to a risk of blood clots primarily in women.
About 76% of adults ages 18 and older have already received two doses in the U.S., primarily with Pfizer and Moderna’s vaccines, according to data from the CDC. However, about 27 million adults in the U.S. have not received their first dose yet, according to Heather Scobie, an official on the CDC’s Covid emergency response team. Novavax executives believe their vaccine will appeal to some people in this group who are not against vaccination, but want an option that uses technology with a longer track record than mRNA.
Novavax’s vaccine was 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to the company’s clinical trial results from the U.S. and Mexico. However, the trial was conducted from December 2020 through September of 2021, months before the highly contagious omicron variant and its various sublineages became dominant in the U.S.
In briefing documents published ahead of Tuesday’s meeting, FDA officials said there is no data available on the effectiveness of the Novavax vaccine against omicron though the shots would likely still protect against severe illness from the variant. Novavax, like every Covid vaccine, was designed to target the original strain of the virus that first emerged in Wuhan, China in 2019. However, the virus has mutated dramatically over the past two years. The effectiveness of all the vaccines against mild illness from Covid has declined substantially as the virus has evolved.
“The study was conducted quite a while ago and said the cases that accrued were not during the time that omicron was circulating,” Dr. Lucia Lee, an official with the FDA’s division of vaccine research, said during her presentation to the committee.
Novavax’s Chief Medical Officer Dr. Filip Dubovsky said data from the company’s adolescent study showed that two doses induced an immune response against omicron, though it was lower than against the Wuhan strain. A third dose boosted the immune response against omicron to levels comparable to the first two doses against the Wuhan strain, Dubovsky said. Novavax plans to ask the FDA to authorize a third dose if the agency clears the primary series for use in the U.S., he said.
“It’s factual that we don’t have efficacy data against omicron, what we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants,” Dubosvky said.
The most common side effects of Novavax’s shots were injection site pain, fatigue, headache and muscle pain, according to FDA briefing documents. However, FDA officials also raised a red flag that Novavax’s vaccine might be associated with a risk of heart inflammation as is the case with Pfizer and Moderna’s shots.
In a safety database of 40,000 Novavax vaccine recipients, four young men who ranged in age from 16 to 28 reported myocarditis or pericarditis within 20 days of receiving a shot, though one of them had a viral illness that could have caused the symptoms. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the hear.
Lee said these cases were concerning because the patients reported their symptoms within days of receiving a Novavax shot, and there is already an established link between mRNA vaccination and heart inflammation among younger men. In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination.
Novavax’s chief safety officer Dr. Denny Kim said the rates myocarditis were essentially the same between people who did and did not receive the vaccine in the clinical study, though it was slightly higher among people who received the shots.
“We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine,” Kim told the committee. He said Novavax is monitoring for cases of heart inflammation in the accumulating data from its clinical trials and real-word use of the shots where they are already authorized.
Novava’x vaccine technology differs in a number of ways from Pfizer and Moderna’s shots. The latter rely on messenger RNA to turn human cells into factories that produce copies of Covid’s spike protein to induce an immune response that fights the virus. The spike is the part of the virus that latches onto and invades human cells.
Novavax produces copies of virus spike outside the human body. The genetic code for the spike is put into a baculovirus that infects moth cells, which then produce copies of the spike that are then purified and extracted. The spike copy, which can’t replicate or cause Covid, is injected into people inducing an immune response against the virus.
The vaccine also uses another ingredient called on adjuvant, which is an extract purified from the bark of a tree in South America, to induce a broader immune response against the virus. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.
Novavax’s vaccine can also be stored at refrigerator temperatures, while Pfizer and Moderna’s shots require deep subzero cold.
Our recombinant, protein-based nanoparticle vaccine technology
It is the one for my family as well, however I still question the need to get vaxed at all if folks have already had covid omni or otherwise.
From COVID or the vaxx?
Oh well.
Doesn’t matter to me.
Me and the First lady already had the Rona.
5.56mm
Doesn’t matter to me.
Me and the First lady already had the Rona.
Same here. My wife and I tested positive Monday, May 2 and we immediately started the 5 day ivermectin protocol. Had a fever and slight headache on Tuesday and all clear on Wednesday. Still tested positive on May 9th and then negative on May 16th.
None of them.................
SNORT.
NovaVax should have been available back in 2020 but was stopped in the US for political reasons.
The shot would have been no more dangerous than the Moderna shot, and probably less dangerous than the Pfizer shot.
That’s nice-I generously give my dose of this vaxx to someone else, and stick with my vitamins, supplements and organic/natural lifestyle. I had a mild case of the Wuhan well over a year ago-and I’ve been fine since-never wear a mask unless a customer insists, either. My bad reactions to vaccines-anaphylactic shock-and equally scary reactions to most drugs is enough for to know that any of this would be a very bad idea for me-so my body will remain vaxx-free...
Novavax took longer, because the protein has to be separated from the liquids in the bioreactors that manufacture it. The vaccine protein is just a genetically engineered COVID-19 spike protein. And just how did Novavax manufacture its vaccine? They created an mRNA segment that coded for the spike protein and got moth cells to take it up and start producing spike protein. It’s the same mechanism used by the Pfizer and Moderna vaccines, except that there is no need for extracting spike protein that is already in the body. I seriously doubt you would want moth proteins that could cause allergic reactions to be in the Novavax vaccine. It’s the purification processes that traditionally have slowed down the development of protein vaccines. If you’re over 45 or so or in a high comorbidity group, you were much better off getting an mRNA vaccine in 2021 than waiting for the Novavax vaccine in mid-2022. It will be interesting to see the safety profile of this vaccine in younger age groups. The Hepatitis B vaccine that has been in use since the mid-1980’s is a protein vaccine and is used in newborns to prevent the transmission of Hepatitis B from mother to child due to exposure to the mother’s blood during childbirth. It is standard procedure in the US to vaccinate newborns just after birth regardless of the Hepatitis B status of the mother.
Unlike Pfizer and Moderna, there is no injection of recombinant material into humans.
I'm more worried about the tree proteins. I really don't see myself as someone standing around trying to generate chlorophyll.
But it might be easier to get wood.
WON’T TAKE IT, even if they fire me. They threatened us before, and still MILLIONS OF US REFUSED. Doesn’t matter what new witches’ brew they try to force on us, it won’t work.
If you’re under 35 years old, WHY THE HELL WOULD NEED A ‘vaccine’ (gene therapy) for COVID-19? You people are so gullible.
This is the one vaccination I would consider, but still, not without more research being done and seeing how it affects those who have already taken it.
I had the Wuhan back in Feb, but I also developed pneumonia and had to be hospitalized for 6 days. It was not fun, but the hospital staff took good care of me.
No. It’s a protein subunit vaccine. Only China has tried making a deactivated whole virus.
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