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Pfizer Submits Phase 1 Data From ‘Booster Jab’ Trial To FDA

Courtesy of ZeroHedge View original post here.

Eager to cash in on the promise of a lucrative market for booster doses of its popular COVID vaccine, Pfizer and BioNTech on Monday submitted their Phase 1 study data to the CDC and FDA.

The data show that people who received a third dose of their mRNA vaccine exhibited "a favorable safety profile and robust immune responses."

Of course, as we learned the first time around, the vaccines can have rare but harmful side effects. They've already been conclusively tied to both mRNA and adenovirus vector vaccines.

And let's not forget what Dr. Robert Malone, who performed pioneering scientific research into the development of mRNA technology, told us about antibody dependent enhancement, and the real reason why herd immunity is no longer possible.

As we have explained previously, ADE is the possibility that 'imperfect' vaccines might actually help foster more virulent COVID variants due to a phenomenon called 'ADE' – antibody-dependent enhancement. Essentially, what doesn't kill the virus makes it stronger. In retaliation for sharing these views, Dr. Malone was ridiculed by colleagues as a conspiracist and an "anti-vaxxer".

Pfizer has already released data showing its vaccine can produce 5x the amount of antibodies that target the delta variant. But in practice, Israel is already seeing patients who have received a third dose become infected.

And the data Pfizer's about to share with the FDA also show that a third dose boosts the body's ability to fight off the delta variant (though this round of data is supposed to focus on safety, not efficacy).

The data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks.

Pfizer CEO Albert Bourla said in a quote that vaccination is society's best chance at fighting COVID.

"Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic."

All of the participants in the third dose Phase 1 trial received the third jab months after receiving their second.

Pfizer said in its press release that it expects to share its Phase 3 data with the federal government shortly.

And as far as their shareholders are concerned, the sooner, the better.


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