The Food and Drug Administration (FDA) wants 75 years before it fully makes public its data on the Pfizer and BioNTech vaccines. And in other news, China’s Evergrande has defaulted, and the world is now bracing for the potential economic impact. In this live Q&A with Crossroads host Joshua Philipp, we’ll discuss these stories and…
Live Q&A: FDA Wants 75 Years to Release Pfizer Data; China’s Economy Braces as Evergrande Defaults
US Regulators Authorize COVID-19 Vaccine Booster Doses for 16- and 17-Year-Olds
U.S. drug regulators on Thursday authorized booster doses of Pfizer’s COVID-19 vaccine for 16- and 17-year-olds. The Food and Drug Administration (FDA) cited in its announcement data showing the vaccine becomes significantly less effective over time. “Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second…
FDA Says It Now Needs 75 Years to Fully Release Pfizer COVID-19 Vaccine Data
The Food and Drug Administration is asking a judge to give it 75 years to produce data concerning the Pfizer and BioNTech vaccine, up 20 years from a previous request. The agency, known as the FDA, told the court it can work faster than its previously proposed 500-pages-per-month-rate. But it also said there are over…
The Week Ahead in Biotech (Dec. 6–Dec. 11)
The Omicron variant concerns were front and center in the markets in the week ended Dec. 3, and biotech stocks did not escape the brunt of selling in the wake of the negative development. The sector recorded weekly losses, reversing course from the previous week’s advance. Regulatory decisions scheduled for the week turned in mixed…
Former FDA Official: Courts Right to Find COVID-19 Vaccine Mandate Unconstitutional
December 3, 2021
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AMERICACCP Virusconstitutional rightsEditor's PicksFDAFeatured TopicsHealth NewsJudiciaryMind & BodyRik MehtaUSVaccines & Safety
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A former Food and Drug Administration (FDA) official says COVID-19 vaccine mandates make little sense and that courts ruled correctly in recently blocking several mandates. Rik Mehta spent time as a deputy division director and a consumer safety officer in the FDA during the Obama administration. He’s also worked for Pfizer, one of the three…
Pfizer Seeks FDA Authorization for COVID-19 Booster Shots in 16-, 17-Year-Olds
Pfizer CEO and Chairman Albert Bourla on Tuesday announced that the company and its partner BioNTech have submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand authorization for its COVID-19 booster shot for use in 16- and 17-year-olds. It comes after U.S. regulators last week expanded the eligibility for a…
Pfizer Seeks FDA Authorization for COVID-19 Booster Shots in 16- and 17-Year-Olds
Pfizer CEO and Chairman Albert Bourla on Tuesday announced that the company and its partner BioNTech have submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand authorization for its COVID-19 booster shot for use in 16- and 17-year-olds. It comes after U.S. regulators last week expanded the eligibility for a…
FDA Advisers Vote to Recommend Merck COVID-19 Pill for Emergency Use Authorization
Outside advisers to the U.S. Food and Drug Administration (FDA) on Tuesday narrowly voted to recommend the agency grant emergency use authorization (EUA) for a drug from Merck and Ridgeback Biotherapeutics to treat COVID-19, called molnupiravir. Members of the FDA’s Antimicrobial Drugs Advisory Committee voted 13 for and 10 against the EUA for molnupiravir, agreeing with…
US Regulators Working to Probe Potential Impact of Omicron Virus Variant
U.S. drug regulators are working to explore how the Omicron variant of the CCP (Chinese Communist Party) virus affects vaccines and other products, the acting head of the Food and Drug Administration (FDA) said Tuesday. “The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available…
FDA Authorizes Moderna, Pfizer COVID-19 Vaccine Boosters for All Adults
The Food and Drug Administration (FDA) on Friday authorized boosters of the Moderna and Pfizer COVID-19 vaccines for all Americans 18 or older. “The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and…
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