Pfizer says he needs a booster shot, but not for Delta

“There is building evidence that the administration of a booster dose of the COVID-19 mRNA vaccine is a potentially urgent new health problem,” the company said.

According to a Kaiser Permanente Southern California study cited by the company, poor performance of two-shot vaccines is generally “not because Delta escaped vaccine protection” but generally “probably due to reduced efficacy.” … apparently … The study showed that two doses were initially more than 90 percent for highly contagious mutants.

Overall, data from Pfizer’s late-stage trials of approximately 44,000 volunteers conducted before the advent of Delta show that two shots up to 96.2% for up to 2 months, up to 90.1% for up to 4 months, and 83.7 after 4 months. Indicates that you have provided% protection.

Data from Israel’s recent deployment of the third shot of Pfizer’s vaccine showed that it boosted protection to 95 percent, the company said. Boosters also had fever as a more common side effect after the third dose than after the first two doses, but did not raise significant new safety concerns.

Pfizer’s double-dose vaccine contrasts with the overwhelming support received by a 15-member committee (formally known as the Vaccine and Related Biopharmaceutical Advisory Committee) approved for emergency use on December 11. In general, the public booster shot demand population is expected to receive a more skeptical welcome on Friday.

Dr. Paul Offit, director of the Philadelphia Children’s Hospital’s Vaccine Education Center, recently said he believed that the mRNA vaccine produced by Pfizer and Cambridge-based Modana would probably be a triple-dose regimen. But he said a third dose of either vaccine is no longer needed for most people, and the federal government should focus on vaccination of millions of Americans who haven’t been vaccinated yet. Stated.

Another committee member, Dr. H. Cody Meissner, director of pediatric infectious diseases at Tufts Medical Center, has not decided how he will vote this week and needs to review the briefing document. Said there is.

Nonetheless, he said that any of the three approved coronavirus vaccines, including Johnson & Johnson’s third vaccine, which uses a different technique, could lead to hospitalization or death. He said he had not yet seen compelling data to lose the strong protection it provides to.

“The point that seems to be consistently lost in all of this is that booster shots aren’t going to end the pandemic,” Meissner said. “The end of the pandemic is to get everyone who refuses to be vaccinated to be vaccinated.”

Pfizer itself acknowledges in the FDA’s filings that “unvaccinated individuals continue to be the cause of most SARS-CoV-2 infections and severe cases.”

A group of international experts, including two FDA vaccine regulators, argued in a treatise published at Lancet on Monday that booster shot approval was premature.

This treatise was co-authored by Marion Gruber and Phil Krause, veteran FDA personnel who have led the authorities’ review of the application of the COVID-19 vaccine. The authors said that “widespread boosts should only be done if there is clear evidence that it is appropriate.” They added that if unnecessary deployment leads to serious side effects, it can impair the acceptance of many vaccines, not just COVID-19.

Gruber and Klaus’ participation in the treatise expressed clear condemnation of President Biden’s administration, which announced plans to launch booster shots on August 18th in the week of September 20th. The announcement seemed to offend some federal health regulators who felt the president. He was ahead of the scientific community by saying that he needed a booster.

This situation prepared for a nasty meeting that could take place on Friday. This is because Gruber is listed as one of the first speakers to start the discussion. Other speakers scheduled for the all-day virtual conference include Dr. Sharon Elroy Price, Head of Public Health, Ministry of Health of Israel.

Jonathan Salzmann can be reached at [email protected]..