3 posts
20 mins ago
There are no serious allergic reactions among coronavirus vaccine volunteers, Pfizer told the FDA committee.
By Amanda Watts
Pfizer officials told U.S. Food and Drug Administration (FDA) vaccine advisers on Thursday that they did not observe serious allergic reactions among volunteers who tested the coronavirus vaccine made by the company.
"Among the 44,000 subjects, we did not see serious allergic reactions to the vaccine," Dr. William Gruber, senior vice president of clinical vaccine research and development at Pfizer, told the FDA's Advisory Committee on Vaccines and Related Biologicals.
"Within the clinical trial, we have not actually seen evidence to suggest a signal related to an allergic reaction to the vaccine," he added.
"Obviously, we are aware of the report that has occurred with the use in the UK," Gruber said, but declined to comment.
Two health workers who received the vaccine on the first day of deployment Tuesday in Britain suffered allergic reactions, England's National Health Service said.
Pfizer excluded from its clinical trial anyone with a history of allergies, such as a serious adverse reaction associated with a vaccine and / or a severe allergic reaction "to any component of the study intervention (s)."
1 hour ago
Pfizer says it searched for the safest vaccine possible while researching candidates
By Amanda Watts
Pfizer's Kathrin Jansen speaks to the FDA's Advisory Committee on Vaccines and Related Biologics on December 10.
(FDA)
Pfizer was seeking the safest possible vaccine by selecting multiple candidates for a coronavirus vaccine, Pfizer's senior vice president and head of vaccine research and development said Thursday.
"Given the enormity of our mission, clinical data was important to us in deciding the right candidate for a COVID-19 vaccine," Pfizer's Kathrin Jansen told the FDA's Advisory Committee on Vaccines and Related Biologics.
"We screened not just one, but four different candidates in Phase 1 so that we could make real-time scientific decisions to select the best candidate," added Jansen.
"With regard to safety, we were looking for the most favorable safety and tolerability profile in both young and old adults.
With regard to immunogenicity, we were looking for the broadest antiviral immune responses, probably associated with efficacy.
And with regard to a rapid response to a pandemic, we were looking for the candidate that could be developed and produced in the most efficient way, ”he said.
Jansen said that when it comes to mRNA vaccines, "we have a deep scientific understanding of how these vaccines work."
He said mRNA vaccines "can be developed and expanded rapidly," offering "a distinct advantage" over other types of vaccines.
2 hours ago
A key meeting
Americans could have the first real ray of hope that the pandemic that has changed their lives will be ended on Thursday, when a key advisory panel takes a vote that could pave the way for the US Food and Drug Administration. The U.S. (FDA) green-lit a covid-19 vaccine in a few days.
The FDA advisory panel will meet Thursday to discuss whether the agency should authorize the emergency use of the Pfizer and BioNTech vaccine at a dark time in the pandemic, when the U.S. recorded the highest count in a single day of more than 3,000 deaths, and some communities continue to resist precautionary measures such as mask-wearing mandates, while a few falsely claim that the pandemic does not exist.
PandemicPfizerVaccine