EU regulators recommend Pfizer/BioNTech’s Covid-19 vaccine for authorization
(CNN) The European Union drugs regulator has recommended authorizing the Pfizer/BioNTech Covid-19 vaccine for use, paving the way for the first phase of the bloc’s mass vaccination program to begin later this week.
In a closed-door meeting in Amsterdam on Monday, the European Medicines Agency (EMA) granted the Pfizer/BioNTech vaccine a conditional marketing authorization, green lighting the drug for distribution.
Before the 27-nation bloc can begin its rollout, the European Commission must give its final approval, which European Commission President Ursula von der Leyen would likely happen later on Monday.
“It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans,” von der Leyen tweeted. “Now we will act fast. I expect a decision by this evening,” she said.
Categories: Europe and Australia, Vaccine
Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).
PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.
https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions