The United States Food and Drug Administration (FDA) is investigating around five serious allergic reactions that occurred after people were administered the Pfizer and BioNTech SE coronavirus vaccine in the country this week. In a press meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, …
Read More »US FDA Panel Recommends Emergency Approval of Moderna Vaccine
A panel of outside advisers to US drug regulators has overwhelmingly endorsed the emergency use of Moderna Inc.’s Covid-19 vaccine, virtually guaranteeing a second choice to protect against the deadly virus in a country devastated by the pandemic. The committee voted 20-0 with one abstention that the benefits of the …
Read More »German partner Pfizer seeks emergency approval, what’s next?
At a time when we are all desperately waiting for a vaccine to reduce the spread of the new coronavirus, the American pharmaceutical company confirmed that Pfizer Inc and its German partner BioNTech have formally applied to the US Food and Drug Administration (FDA ) an emergency use authorization. for …
Read More »Covid-19 Vaccine: 5 Things You Should Know About Pfizer’s Encouraging Trial Results
Pfizer Inc. and BioNTech SE announced Wednesday that the final efficacy analysis of their vaccine candidate, BNT162b2, undergoing the phase 3 trial met all of the study’s primary efficacy endpoints. Biotech companies said the study indicated a 95 percent vaccine efficacy rate, close to the efficacy rate found in early …
Read More »India May Approve COVID-19 Vaccines Showing 50% Efficacy In Clinical Trials
NEW DELHI: Taking as a reference the benchmarks set by the World Health Organization and the US Food and Drug Administration, India’s drug regulator has said that it plans to approve the covid-19 vaccines that can provide immunity to at least 50% of the participants in phase 3 clinical trials. …
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