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7 Jan 2022, 8:22 am
‘Paramount importance’: Judge orders FDA to hasten release of Pfizer vaccine docsBy Jenna Greene, Reuters, Jan. 7, 2022A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.That’s roughly 75 years and four months faster than the FDA said… [read post]
6 Jan 2022, 9:03 pm
Food and Drug Administration (FDA) and the CDC approved Pfizer’s COVID-19 vaccine booster for 12 to 15 year olds, making all individuals over the age of 12 eligible for a booster after completing an initial two-shot series. [read post]
6 Jan 2022, 8:41 am
AstraZeneca, GE Healthcare USA Holding, Johnson & Johnson, Pfizer, Hoffmann-La Roche, and other companies are accused by plaintiffs, family members of victims of the attack in Iraq by the Mahdi group, of providing illegal support to terrorist acts in two ways. [read post]
5 Jan 2022, 1:34 pm
California Immunization Requirements for Covered Workers COVID-19 VaccinePrimary vaccination seriesWhen to get the vaccine booster doseModerna or Pfizer-BioNTech1st and 2nd dosesBooster dose 6 months after 2nd doseJohnson and Johnson [J&J]/Janssen1st doseBooster dose 2 months after 1st doseThe orders also require twice-weekly testing of workers who are eligible for boosters but not yet boosted; it also maintains regular testing for workers who may be exempt from the vaccination… [read post]
4 Jan 2022, 6:12 pm
“U.S. court revives lawsuit against Pfizer, others on Iraq terrorism funding claims”: Mike Scarcella of Reuters has this report on a ruling that the U.S. [read post]
3 Jan 2022, 3:34 pm
Moderna or Pfizer-BioNTech1st and 2nd dosesSix months after second doseJohnson and Johnson [J&J]/Janssen1st doseTwo months after first doseIndividuals exposed to someone with COVID-19 who are either (1) unvaccinated or (2) vaccinated and booster-eligible but haven’t yet received their booster dose — including individuals in both categories who were infected with SARS-CoV-2 within the last 90 days — must quarantine. [read post]
3 Jan 2022, 2:14 pm
Unvaccinated individuals and individuals whose vaccines were not administered recently (six months for the Pfizer and Moderna vaccines, and two months for the Johnson & Johnson vaccine) and who have not received a booster shot should quarantine for five days, followed by an additional five days of wearing a mask. [read post]
3 Jan 2022, 10:59 am
After analyzing data from Israel on 6,300 children ages 12 through 15 who received a Pfizer booster dose, the FDA concluded that no new safety concerns had arisen. [read post]
30 Dec 2021, 9:03 pm
In lieu of our regular Friday feature—the Week in Review—The Regulatory Review is recapping some of the top regulatory news from the past year, including the coronavirus pandemic, the Biden Administration’s first regulatory initiatives, and more. [read post]
30 Dec 2021, 5:30 pm
Israel was among the first countries to roll out Pfizer’s coronavirus vaccine a year ago and began rolling out boosters last summer. [read post]
30 Dec 2021, 11:39 am
Those who are unvaccinated; Those who have completed their Pfizer or Moderna COVID-19 vaccine series more than 6 months ago and are not boosted; and Those who have completed their J&J vaccine more than 2 months ago and are not boosted. [read post]
27 Dec 2021, 9:41 am
The CDPH recommends workers who initially received the Moderna or Pfizer vaccine to receive the booster six months after their second dose. [read post]
27 Dec 2021, 4:52 am
For the Pfizer-BioNTech COVID-19 vaccine, the primary vaccination series takes 21 days to complete. [read post]
27 Dec 2021, 4:00 am
On October 8th, a federal judge presiding over the Zantac multidistrict litigation ruled that the brand manufacturers of Zantac — GlaxoSmithKline, Sanofi, Pfizer, and Boehringer Ingelheim — should face lawsuits by people formerly prescribed the drug. [read post]
26 Dec 2021, 4:52 pm
Background On 2 November 2021 the BMJ published an investigative article based on a whistle-blower report, which called into question data integrity and regulatory oversight issues surrounding Pfizer’s pivotal phase III Covid-19 vaccine trial. [read post]
23 Dec 2021, 6:15 pm
The clearance for the drug, called molnupiravir, came a day after the agency signed off on Pfizer’s COVID-19 antiviral, called Paxlovid. [read post]
Moderna booster update: How effective is it against the omicron variant? Here’s what scientists know
23 Dec 2021, 3:23 pm
(That’s comparable to the rate found shortly after receiving one shot of the Pfizer vaccine, which quickly wanes.) [read post]
23 Dec 2021, 9:34 am
Giant pharmacies are offering the Moderna and Pfizer booster vaccinations at all ... [read post]
22 Dec 2021, 1:44 pm
The Food and Drug Administration on Wednesday authorized the first pill against the coronavirus, a five-day regimen developed by Pfizer, according to the Washington Post. [read post]
22 Dec 2021, 11:17 am
Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or… [read post]
