Key FDA panel debates Pfizer vaccine

Key FDA panel debates Pfizer vaccine

Illustrative: Vials with COVID-19 vaccine stickers attached and syringes with the logo of U.S. pharmaceutical company Pfizer and German partner BioNTech, on November 17, 2020.

The committee was charged with voting on the following question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risk for use in individuals 16 years of age and older?" Federal officials, who are coordinating distribution with the states, have ordered 800 million vaccine doses from six drugmakers - including 100 million each from Pfizer and Moderna - that are manufacturing the vaccines even as they work their way through the FDA approval process.

"At this time, we await further information about EMA's investigation and will respond appropriately and in accordance with European Union law", the companies said.

Along with Moderna, vaccines from AstraZeneca and Johnson & Johnson are also still being reviewed and considered for approval.

The decision came as COVID-19 cases surge to ever-higher levels across the U.S., with deaths hitting an all-time, one-day high of more than 3,100 on Wednesday. Pfizer and BioNTech were the first to apply for emergency use authorization from the FDA.

The no-fault program was announced Thursday, as Canada gets ready to roll out the first of seven new vaccines.

Once a safe way to transport the vaccines to long-term care homes has been worked out, tricky because of the temperatures involved, the vaccines will also be administered to long-term care home residents.

That means it could be several months before things start get back to normal and Americans can put away their masks.

A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline.

"The occurrence of any allergic reaction was one of the factors monitored in the phase three clinical trial of this Pfizer/BioNTech Covid-19 vaccine, the detailed data from which was released yesterday". In the wake of Health Canada's announcement, Grindrod spoke with Bourke on her perspective on the Pfizer vaccine, the impressive transparency behind the vaccine's trials and efficacy, and the concerns some Canadians may have about the drug's safety.

"Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine", the agency's chief executive June Raine said.

FDA Commissioner Steven Hahn, ahead of the meeting on Thursday, said the agency was carefully reviewing all the data on Pfizer's vaccine, including potential allergic reactions in the wake of the UK's warning.

They added that no BioNTech or Pfizer systems had been breached in connection with the incident and that they weren't aware that any study participants had been identified as a result of the data being accessed.

The country has seen a recent surge of COVID-19 cases as colder weather pushes people indoors, where the virus can more easily spread.

During the public comment session, a former FDA official spoke of a need for careful consideration of study volunteers' needs in designing trials of COVID vaccines. Doing that could make it impossible to get answers to long-term questions, including how long the protection lasts.

Those who aren't part of the higher-risk categories would be given vaccine shots later. Others argued that the 16- and 17-year-olds wouldn't be among the first to receive the vaccine, allowing for time to research the effects it may have on this age group.

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