Pfizer to seek FDA authorization for booster of COVID-19 vaccine

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Pfizer and BioNTech announced Thursday that they plan to seek authorization from the Food and Drug Administration (FDA) for a third dose of their COVID-19 vaccine, saying it would provide even stronger protection.

In a statement released Thursday afternoon, the companies said they have seen “encouraging data” from an ongoing trial of the booster shot, adding that it provides levels of neutralizing antibodies five to 10 times higher, when administered six months after the second dose. The companies plan to submit data “in the coming weeks.”

It will be up to U.S. regulators — the FDA and the Centers for Disease Control and Prevention — whether to recommend a third dose. Continue reading.

‘They didn’t like me’: Trump attacks Pfizer in conspiratorial rant after FDA pauses Johnson & Johnson vaccine

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This Tuesday, the Biden administration recommended a “pause” in using the single-dose Johnson & Johnson COVID-19 vaccine after reports of extremely rare blood clots in six people out of approximately 6.8 million doses that have been administered.

Former President Donald Trump took the opportunity to jump on the news, releasing a statement saying the Biden administration “did a terrible disservice to people throughout the world” in calling for the pause, adding that doing so would cause the “reputation” of the vaccine to be “permanently damaged.” 

“The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer,” Trump said.  Continue reading.

Pfizer says COVID vaccine was 100% effective in trial of children ages 12 to 15

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Pfizer and BioNTech announced Wednesday that their coronavirus vaccine was found to be 100% effective at protecting against COVID-19 in a trial of more than 2,200 children between the ages of 12 and 15.

The big picture: Pfizer CEO Albert Bourla said the companies plan to submit clinical trial data to the FDA for emergency use authorization in the coming weeks, with the hope of vaccinations for adolescents beginning before the start of the next school year.

  • The trial’s data will also be submitted to the European Medicines Agency (EMA) for emergency use authorization. Continue reading.

Pfizer, Moderna vaccines are 90% effective after two doses in study of real-life conditions, CDC confirms

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Report on essential workers is one of the first to estimate protection against any infection, regardless of symptoms

The Pfizer-BioNTech and Moderna vaccines being deployed to fight the coronavirus pandemic are robustly effective in preventing infections in real-life conditions, according to a federal study released Monday that provides reassurance of protection for front-line workers in the United States.

In a study of about 4,000 health-care personnel, police, firefighters and other essential workers, the Centers for Disease Control and Prevention found that the vaccines reduced the risk of infection by 80 percent after one shot. Protection increased to 90 percent following the second dose. The findings are consistent with clinical trial results and studies showing strong effectiveness in Israel and the United Kingdom, and in initial studies of health-care workers at the UT Southwestern Medical Center and in Southern California.

The CDC report is significant, experts said, because it analyzed how well the vaccines worked among a diverse group of front-line working-age adults whose jobs make them more likely to be exposed to the virus and to spread it. Continue reading.

Pfizer: COVID-19 vaccine testing shows 95 percent efficacy, emergency use application planned ‘within days’

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Pfizer on Wednesday announced that final data on its coronavirus vaccine candidate showed it to be 95 percent effective, adding that the company would be applying for Federal Drug Administration (FDA) emergency authorization “within days.” 

Pfizer said that the vaccine candidate, developed with German company BioNTech, is 95 percent effective “against COVID-19 beginning 28 days after the first dose.” 

The company last week said that interim data revealed its vaccine to be 90 percent effective.  Continue reading.

Real Stories Of Americans Who Won’t Be Helped By Trump’s Faux Pfizer Victory Tweet

Trump did not successfully negotiate lower drug prices for Americans this week, as he falsely claimed. All that happened was a single pharmaceutical corporation, Pfizer,  agreed to postpone its latest round of drug price increases. Prescription drug prices – already sky high and unaffordable for many Americans – did not decrease by a cent, and many have even increased.

Trump is a puppet of the pharmaceutical industry. He’s already given pharmaceutical companies billions in tax breaks, and now his White House has come under fire for working behind closed doors to help Novartis, a giant pharmaceutical company, make hundreds of millions more.

Meanwhile, Americans across the country continue to struggle with rising costs of prescription drugs. Read their stories below: Continue reading “Real Stories Of Americans Who Won’t Be Helped By Trump’s Faux Pfizer Victory Tweet”