- EMA authorizes Pfizer/Biontech vaccine as new SARS-CoV-2 variant emerges (bioworld.com)Comirnaty (BNT162b2) Vaccine (precisionvaccinations.com)
The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use...The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27...“This is the first marketing authorization of a COVID-19 vaccine in the EU. It is valid in all 27 member states at the same time,” said EMA Executive Director Emer Cooke. “There is a firm scientific foundation for roll out,” she said...READ MORE
- Moderna’s Covid-19 Vaccine Gets Backing From FDA Advisory Panel (wsj.com)Covid-19 Vaccine Trial Volunteers Note Occasional Harsh Side Effects (wsj.com)
A Food and Drug Administration advisory panel recommended Thursday that Moderna Inc.’s MRNA 5.09% Covid-19 vaccine be cleared for broad use, setting the stage for the FDA to grant an expected emergency-use authorization by late Friday...The advisory panel’s vote was 20-0, with one abstention, to recommend use of the Moderna vaccine for people 18 years of age and older. That puts it in line to become the second Covid-19 vaccine to be granted an emergency use authorization, following the FDA’s green light of a vaccine from Pfizer Inc. and BioNTech SE last week...READ MORE
- Britain to spend $5 billion on vaccines and bear liability, watchdog says (reuters.com)
Britain has agreed to spend 3.7 billion pounds ($4.93 billion) on COVID-19 vaccines and in most cases will bear the liability if claims are made against the pharmaceutical firms involved...The government has agreed supply deals for 357 million doses of seven different candidate shots, but has not gone into detail about how much it has spent or indemnity agreements, citing commercial confidentiality around the contracts...READ MORE
- U.K. Regulator Warns People With ‘Significant’ Allergies To Avoid Pfizer-BioNTech Vaccine (forbes.com)Explainer: What do the UK allergic reaction cases mean for Pfizer's COVID-19 vaccine (reuters.com)FDA staffers sing Pfizer/BioNTech COVID-19 shot's praises ahead of key committee meeting (fiercepharma.com)
One day after the U.K was hailed for administering the first coronavirus vaccine shots in the west, Britain’s medicines regulator has warned people with a history of “significant” allergies to avoid the Pfizer-BioNTech Covid-19 vaccine...Two National Health Service staff members experienced anaphylactoid reactions after receiving the...vaccine on the first day of the U.K.’s vaccination campaign...READ MORE
- FDA investigating allergic reactions to Pfizer vaccine reported in multiple states (thehill.com)Vaccinations at Chicago-area hospital to resume after 4 workers experience adverse reactions (fox32chicago.com)
The Food and Drug Administration is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in multiple states after it began to be administered this week...Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters late Friday that the reactions had been reported in more than one state besides Alaska and that the FDA is probing five reactions...“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said...READ MORE
- Las Vegas hospital administers Nevada’s first batch of COVID vaccines (thenevadaindependent.com)
University Medical Center became the first hospital in Nevada to administer the COVID-19 vaccine on Monday, marking a major turning point...UMC began administering the vaccine at 11:45 a.m., and by 4 p.m., the hospital had vaccinated more than 200 frontline health care workers in line with guidance from the Centers for Disease Control and Prevention and the state, said UMC CEO Mason Van Houweling...ICU nurse Roshele Ward was the first UMC employee — and the first Nevadan — to be vaccinated...READ MORE
- Historic U.S. vaccine campaign begins with first shipments ‘delivering hope’ to millions (reuters.com)U.S. expects to have immunized 100 million against COVID-19 by end of March -Slaoui (reuters.com)U.S. CDC director 'proud' to sign advisory panel recommendation of COVID vaccine (reuters.com)White House, other top officials to get early vaccine access (apnews.com)
The first shipments of COVID-19 vaccine left on trucks and planes early on Sunday, kicking off a historic effort to stop a surging pandemic that is claiming more than 2,400 lives a day in the United States...Mask-wearing workers at a Pfizer Inc factory in Michigan began packing the first shipments of the vaccine developed with German partner BioNTech SE in dry ice shortly after 6:30 a.m. ET (1130 GMT) on Sunday...Trucks carrying pallets of boxed, refrigerated vaccine began rolling away from the Kalamazoo facility, escorted by body armor-clad security officers. The shots then were loaded onto FedEx and United Parcel Service planes that will whisk the precious cargo across the country...“Today, we’re not hauling freight, we’re delivering hope,”...READ MORE
- FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine (fda.gov)FDA grants authorization to Moderna’s Covid-19 vaccine, the second in the U.S. (statnews.com)
Today, the U.S. Food and Drug Administration issued an emergency use authorization for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older...READ MORE
- Canada getting 168K Moderna vaccine doses before year end (apnews.com)
Prime Minister Justin Trudeau said Tuesday that Canada has contracted to receive up to 168,000 doses of the Moderna COVID-19 vaccine before the end of December, pending approval by the country’s health regulator...Canadians began receiving vaccine shots developed by Pfizer and BioNTech on Monday and Trudeau said Canada expects to receive about 200,000 doses from Pfizer next week. Canada received an initial batch of 30,000 this week...READ MORE
- U.S. FDA authorizes Pfizer COVID-19 vaccine for emergency use (reuters.com)
The U.S. Food and Drug Administration said it authorized the use of Pfizer Inc’s COVID-19 vaccine on Friday, with the first inoculations expected within days...The FDA granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in preventing the disease in a late-stage trial. It said the vaccine can be given to people aged 16 and older...READ MORE