U.S. drug regulators have rejected a request to revoke emergency authorization for Pfizer’s COVID-19 vaccine for 12- to 15-year-olds. “Petitioner has provided no basis to demonstrate that the EUA should be revoked,” Dr. Peter Marks, a top Food and Drug Administration (FDA) official, wrote in a June 17 letter, which was made public on July…
FDA Rejects Request to Revoke Emergency Authorization of Pfizer’s Vaccine for Some Children
Pfizer Leaves COVID-19 Product Forecast Unchanged, Shares Fall
Pfizer Inc. did not raise its 2022 forecast for sales of its COVID-19 vaccine and antiviral treatment on Thursday, and its shares fell nearly 5 percent before recovering. The U.S. drugmaker maintained its full-year forecast of around $54 billion for its COVID-19 products, even as second-quarter sales of its Paxlovid antiviral pills were much higher-than-expected,…
BioNTech, Pfizer Sue CureVac in US Over COVID-19 Vaccine Patent Claims
FRANKFURT—COVID-19 vaccine maker BioNTech said on Tuesday that it and partner Pfizer have filed a complaint with the U.S. District Court in Massachusetts, seeking a judgment that they did not infringe U.S. patents held by rival CureVac. The lawsuit, filed Monday, said CureVac is trying to profit from the success of BioNTech and Pfizer’s COVID-19…
80K New Pfizer Docs: Why Did So Many Participants With ‘Minor’ Adverse Events Withdraw From Trial? | Facts Matter
The latest trove of Pfizer documents was released by the FDA. These documents reveal information about the clinical trials that Pfizer was running prior to getting emergency use authorization. This was actually the fifth batch of Pfizer documents released by the FDA thus far. The backstory is that the FDA has in their possession approximately…
Canada Approves First COVID-19 Vaccine for Youngest Kids
Health Canada says it has approved the use of Moderna’s COVID-19 vaccine for children as young as six months old. In a July 14 statement, the federal health regulator announced it has authorized the use of Moderna’s Spikevax COVID-19 vaccine for children 6 months to 5 years of age, making Moderna the first pharmaceutical company permitted…
Highly Prescribed ‘Benign’ Medication Detected in 10 Percent of Overdose Deaths
A commonly prescribed painkiller and anticonvulsant (seizure medication) widely believed to be “benign” has become increasingly associated with overdose deaths in the United States. The medication is gabapentin, commonly marketed as Neurontin, Horizant, and Gralise. Over the years, gabapentin prescribing has steadily increased, with 64 million prescriptions dispensed in 2016, making the drug the 10th…
LIVE 10:30 AM ET: The ‘Universal Vaccine’ Agenda for Annual Vaccinations and an Endless Pandemic
Pfizer is developing a “universal vaccine,” which can modify the new mRNA vaccines to fight against new viruses as they emerge. The new type of vaccine isn’t just being developed by Pfizer either, and officials including Dr. Anthony Fauci have touted the vision of the vaccines as being an end-goal of dealing with COVID-19. The…
LIVE: The ‘Universal Vaccine’ Agenda for Annual Vaccinations and an Endless Pandemic
Pfizer is developing a “universal vaccine,” which can modify the new mRNA vaccines to fight against new viruses as they emerge. The new type of vaccine isn’t just being developed by Pfizer either, and officials including Dr. Anthony Fauci have touted the vision of the vaccines as being an end-goal of dealing with COVID-19. The…
LIVE 7/13 at 10:30AM ET: The ‘Universal Vaccine’ Agenda for Annual Vaccinations and an Endless Pandemic
Pfizer is developing a “universal vaccine,” which can modify the new mRNA vaccines to fight against new viruses as they emerge. The new type of vaccine isn’t just being developed by Pfizer either, and officials including Dr. Anthony Fauci have touted the vision of the vaccines as being an end-goal of dealing with COVID-19. The…
FDA Grants Full Approval to Pfizer’s COVID-19 Vaccine for 12- to 15-Year-Olds
Pfizer and BioNTech’s COVID-19 vaccine for adolescents aged between 12 and 15 years has been granted full approval by the U.S. Food and Drug Administration (FDA), the companies announced on Sunday. The vaccine will be sold under the brand name Comirnaty and is the first and only COVID-19 vaccine to be granted FDA approval for children aged 12 and older,…
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