Tag: Pfizer COVID-19 vaccine

CDC panel recommends Pfizer COVID vaccine for adolescents

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Adolescents as young as 12 years old across the country can soon start receiving the Pfizer-BioNTech coronavirus vaccine after a federal advisory panel endorsed the measure Wednesday.

The 14-0 vote, with one recusal from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices was part of the final process before the shot becomes widely available to the younger population.

Once CDC Director Rochelle Walensky signs off on the panel’s recommendation, vaccinations will begin in most states, although some clinics in states including Pennsylvania, Maine and Georgia did not wait.  Continue reading.

FDA authorizes Pfizer COVID-19 vaccine for adolescents

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The Food and Drug Administration (FDA) on Wednesday gave the green light for the Pfizer-BioNTech coronavirus vaccine to be used in adolescents 12 to 15 years old, a move that will make millions more people eligible for a vaccine.

The highly anticipated decision is a key step toward ensuring middle and high schools can operate for full in-person learning in the fall — and a major boon to parents concerned about the safety of summer activities.

The FDA has been reviewing the amended application from Pfizer and BioNTech for more than a month. The companies cited research from their clinical trial in late March that found the vaccine was effective in the younger population and produced strong antibody responses. The side effects were also about the same as the older population. Continue reading.

Pfizer-BioNTech vaccine offers strong protection against key variants of concern, real-world data from Qatar shows

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The Pfizer-BioNTech coronavirus vaccine provides strong protection against two concerning variants of the virus, including the one that has most worried scientists because it can evade parts of the immune response, according to new data from Qatar.

The study, published as a letter in the New England Journal of Medicine, found that the Pfizer-BioNTech vaccine was about 90 percent effective at blocking infections caused by the B.1.1.7 variant, a more transmissible version of the virus now fueling outbreaks around the world. That encouraging finding was not a surprise, but the study also found that efficacy eroded only slightly, to 75 percent, against the B.1.351 variant that was first detected in South Africa.

The B.1.351 variant carries mutations that help it elude some antibodies and as a result is considered by many experts the most challenging variant among those that have been identified. Because the Pfizer-BioNTech vaccine and one from the biotechnology company Moderna were tested in clinical trials before that variant emerged, it had remained unclear until now whether protection would be eroded by the variant. While the new study suggests the vaccine is somewhat less protective against the variant, it offered strong protection, particularly against severe, critical or fatal cases of covid-19, the illness caused by the virus. Continue reading.

States report confusion as government reduces vaccine shipments, while Pfizer says it has ‘millions’ of unclaimed doses

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Officials in multiple states said they were alerted late Wednesday that their second shipments of Pfizer-BioNTech’s vaccine had been drastically cut for next week, sparking widespread confusion and conflicting statements from Pfizer and federal officials about who was at fault.

The reduction prompted concern in health departments across the country about whether Operation Warp Speed, the Trump administration’s vaccine accelerator program, could distribute doses quickly enough to meet the target of delivering first shots to 20 million people by year’s end.

A senior administration official, speaking on the condition of anonymity to discuss internal plans, said the revised estimates were the result of states’ requesting an expedited timeline for locking in their allocations for the following week; notification of how many doses they could order each week was consequently advanced from Friday to Tuesday. Since Pfizer is producing doses daily, the official said, fewer doses were available Tuesday than will be available on Friday. Continue reading.

FDA clears nation’s first COVID-19 vaccine

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The country’s first coronavirus shots are one step closer to getting injected into the general public after the Food and Drug Administration (FDA) granted emergency authorization late Friday to the vaccine manufactured by Pfizer and BioNTech.

The announcement comes as the country is reeling from a new surge of COVID-19 infections, with deaths now exceeding 3,000 people each day.

Now that the FDA has given the vaccine the green light, the federal government is able to start distributing it to states. However, vaccinations won’t begin until after a Centers for Disease Control and Prevention (CDC) committee recommends the vaccine and the CDC accepts that recommendation. Continue reading.

FDA panel votes in favor of Pfizer COVID-19 vaccine

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A federal panel of outside experts on Thursday endorsed a coronavirus vaccine from Pfizer and BioNTech, and recommended the Food and Drug Administration (FDA) move forward with emergency authorization.

The panel voted 17-4, with one abstention, that the safety and efficacy of the vaccine outweigh the risks for use in individuals age 16 and older. 

The vote is an important step, as the country is poised to start an unprecedented vaccination campaign to stop the COVID-19 pandemic. Continue reading.

Trump Administration Passed on Chance to Secure More of Pfizer Vaccine

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The pharmaceutical company offered the government a chance to lock in additional supplies before its vaccine was proved effective in clinical trials.

WASHINGTON — Before Pfizer’s coronavirus vaccine was proved highly successful in clinical trials last month, the company offered the Trump administration the chance to lock in supplies beyond the 100 million doses the pharmaceutical maker agreed to sell the government as part of a $1.95 billion deal over the summer.

But the administration, according to people familiar with the talks, never made the deal, a choice that now raises questions about whether the United States allowed other countries to take its place in line.

While two vaccines, including Pfizer’s, have proved to be highly effective against Covid-19, and a third also appears at least moderately effective, supplies are shaping up to be scarce in the coming months as infections, hospitalizations and deaths surge to new highs. And while Pfizer is now negotiating with the administration to provide more of its vaccine, people familiar with the talks say the company cannot guarantee that it will be able to deliver more than the initial 100 million doses — enough to inoculate 50 million people since its vaccine requires two shots — before perhaps next June. Continue reading.

Data show COVID-19 vaccine candidate more than 90 percent effective, Pfizer says

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Pfizer announced Monday morning that late-stage clinical trial data show that its vaccine candidate is over 90 percent effective in preventing COVID-19.

The announcement was widely greeted as a sorely needed positive development in the fight against the virus, which is raging across the country.

The drugmaker said it conducted an analysis of 94 confirmed cases in trial participants after enrolling 43,538 participants in a larger study. The company added that it hopes to have the amount of safety data required for a Food and Drug Administration (FDA) emergency use authorization by the third week of November. Continue reading.