(Adds expert comment from meeting, New Zealand case, background) Aug 30 (Reuters) – An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) on Monday unanimously recommended the Pfizer Inc and BioNTech Se COVID-19 vaccine for people age 16 and older, an important step after it gained full U.S. approval. The Food and Drug Administration last week granted full approval to the vaccine that was previously available under the agency’s emergency use authorization (EUA), which… Source link
Read More »Pfizer/BioNTech vaccine effective after 6 months; Moderna starts variant trial
Pfizer (PFE) and BioNTech’s (BNTX) COVID-19 vaccine is proving effective six months after the second dose, according to an ongoing analysis of the Phase 3 trial participants. The vaccine showed 91.3% efficacy against COVID-19, slightly lower than the original 95% seen in Phase 3 trials. The data, from 12,000 of the more than 44,000 adults in the trial, is a result of observations from seven days through six months after the second dose was received. The two companies announced the results in a… Source link
Read More »FDA advisory committee recommends Pfizer/BioNTech vaccine authorization
Pfizer (PFE) and BioNTech’s (BNTX) vaccine is one step closer to being distributed to health workers and nursing home residents, with the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee recommending its emergency use authorization (EUA) on Thursday. The 17-4 vote, with one abstention, could result in the FDA authorizing the vaccine as early as Friday, which would then trigger the distribution of the vaccine throughout the 64 jurisdictions in the U.S., including 50… Source link
Read More »Pfizer/BioNTech press for emergency vaccine use as WHO hits Gilead’s remdesivir
The U.S. has moved one step closer to getting its first COVID-19 vaccine, with BioNTech (BNTX) — Pfizer’s (PFE) development partner — filing for emergency use authorization Friday morning. “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Pfizer CEO Albert Bourla. With the coronavirus… Source link
Read More »