Posted on 08/06/2021 6:48:19 PM PDT by SeekAndFind
Novavax announced that it will delay the submission of its Covid-19 vaccine to the Food and Drug Administration for emergency use authorization until its fourth quarter.
Shares of the biotechnology company slipped 10% after the bell.
The company has filed for regulatory approval in India, Indonesia and the Philippines. Plans to submit the vaccine for emergency use listing at the World Health Organization are set for August, Novavax announced.
Approval by the WHO will allow the vaccine to be distributed globally via vaccine sharing initiatives at the global agency.
Novavax data from clinical trials indicate that a booster dose of the vaccine candidate provides a 4-fold increase in neutralizing antibody levels after a two-dose regimen of an approved vaccine.
The data also indicates that a booster dose of a Novavax vaccine six months after a two-dose regimen of an approved vaccine could provide increased protection against the delta variant and other variants.
Despite the delay in U.S. authorization, the company says it is still on track to produce 100 million doses per month by the end of the third quarter and 150 million per month by the end of the fourth quarter.
(Excerpt) Read more at msn.com ...
The US market is saturated. Their efforts are better spent elsewhere for now.
And, millions of life-saving ivermectin tablets languish on pharmacy shelves, while the vaccine merry-go-round accelerates.
It’s insane !
too soon, have to wait for midterms to get into gear~/s
My guess is that big Pharma is unwilling to share the booty until the plan of removing the emergency status of the other vaccines. Once that certainty occurs by Labor Day, then they will be happy to let Novavax process under the haze of an emergency use only authorization.
The fix has long been in. Little Tony Fauci and his club mates have this all sorted out. Why else have they allowed Ivermectin and even Regeneran from being used?
RE: Why else have they allowed Ivermectin and even Regeneran from being used?
I thought Monoclonals ( like Regeneron ) was allowed already?
I know that Trump and Rudy Giuliani BOTH were administered Monoclonal Antibodies.
This is the one and only vaccine that I was considering using, and now it’s being delayed.
me too
Regeneron’s Monoclonal Antibody therapy has an Emergency Use Authorization for Covid. Should be the first line of defense for anybody at risk diagnosed with a mild-to-moderate case of the virus.
Regenerons product now approved for eua for people exposed to someone with covid 19. It is a two monoclonal antibody cocktail... MAB’s arent without risk either...but have at least close to a decade of use. Some are worse than others.
Be careful out there. Lots of immortalists or poor immunological response to vaccine folk out there.
RE: Regenerons product now approved for eua for people exposed to someone with covid 19.
So, at what point of the disease can a Covid infected person ask for this MAB to be injected?
Suppose I was diagnosed to be positive and start experiencing symptoms.... Can I ask for it on an outpatient basis?
The other question is — is it available in every clinic and hospital?
Available in some hospitals and specialty infusion clinics.
RE: Available in some hospitals and specialty infusion clinics.
At what stage of the disease? Can I ask for it outpatient at the onset of symptoms?
There are people that will not take an mRNA vax.
Novavax is based on the more conventional technology of the Rubella vax and does not interact with DNA or the DNA process.
There’s a subset of folks out there that will take this one, and not the others.
monoclonal antibodies are not only in use but the authorization has been expanded to include post exposure prophylaxis in some cases
It is only a. outpatient medication at this time. Anyone i’ll enough to be hospitalized does not qualify
Hopefully it’s out soon.
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