- CDC OKs Vaccine Mixing & Matching as Effectiveness Evidence Mounts (biospace.com)
The Centers for Disease Control and Prevention has given its go-ahead for the use of Moderna's and Janssen's COVID-19 vaccines as booster shots...after their initial series as well as the approval of mixing and matching vaccines...READ MORE
- Project Veritas: Pfizer downplays COVID-19 vaccine’s ties to fetal tissue from abortions (washingtontimes.com)
No pharmaceutical company is eager to broadcast the role that abortion-derived fetal cell lines played in the development of the COVID-19 vaccine, and that reportedly includes Pfizer...Project Veritas released a video Wednesday in which Melissa Strickler, Pfizer manufacturing quality auditor, produced what she identified as internal emails that showed top officials discussing how to downplay in corporate communications the role of embryonic cell lines in the COVID-19 vaccine program...“If they’re being this deceptive about it, I don’t feel comfortable being silent,” said Ms. Strickler in the video interview with Project Veritas President James O’Keefe...READ MORE
- New York hospitals fire, suspend staff who refuse COVID vaccine (reuters.com)
New York hospitals on Monday began firing or suspending healthcare workers for defying a state order to get the COVID-19 vaccine, and resulting staff shortages prompted some hospitals to postpone elective surgeries or curtail services...New York City Mayor Bill de Blasio told a news conference the city's hospitals were not yet seeing a major impact from the mandate, adding he worried about other areas of the state where vaccination rates are lower...A spokeswoman for Catholic Health, one of the largest healthcare providers in Western New York, said it had reached full compliance, counting staff members who had been vaccinated, those with exemptions and some who had been suspended without pay...READ MORE
- FDA advisors reject Pfizer COVID-19 boosters for all, but agree to shots for elderly and high risk (fiercepharma.com)
An FDA advisory panel knocked down Pfizer and BioNTech's pitch for COVID-19 booster shots for everyone, but rebounded on the committee's follow-up allowance for third shots in the elderly and high-risk people...he committee voted 16-2 to reject Pfizer’s bid for a full approval for boosters for people 16 and older...“It may eventually be indicated for the general population,” committee member Ofer Levy, M.D, said. “I just don’t think we’re there yet in terms of the data.”...READ MORE
- Is mRNA the Future of Drug Development? (biospace.com)
Before the Pfizer-BioNTech COVID-19 vaccine authorization, there were no mRNA therapies approved anywhere in the world. The idea of using messenger RNA as a way to get your body to be the drug manufacturer has been around for some time, but only in recent years has it become practical. And it was the COVID-19 pandemic that provided the opportunity for the technology to push ahead...In terms of cancer...BioNTech has two types of mRNA vaccines for cancer. “First, we have our off-the-shelf vaccines, where we’ve identified molecular features of tumors that are shared by many patients...By targeting these molecules, you can fight the cancer without getting collateral damage to healthy cells.”...“Second, we have highly personalized vaccines. We identify cancer mutations that are unique to every patient...We biopsy the tumor, sequence it, and design a unique, individualized vaccine for each patient.”...READ MORE
- How many employees have hospitals lost to vaccine mandates? Here are the numbers so far (fiercehealthcare.com)New York's largest healthcare provider fires 1,400 unvaccinated workers (reuters.com)Moody's: Hospitals, staffing agencies shouldering the labor shortage while insurers are largely immune (fiercehealthcare.com)
The past several months have seen thousands of hospitals announce COVID-19 vaccination requirements for staff and clinicians as a condition of employment...Although controversial, the policies picked up steam when Pfizer and BioNTech’s Comirnaty received a full regulatory approval and then really kicked into gear when the Biden administration made workforce vaccination a requirement for Medicare and Medicaid participation...Most health system leaders and professional organizations have been supportive of the requirement, with some describing vaccination as “the logical fulfillment of the ethical commitment of all healthcare workers to put patients as well as residents of long-term care facilities first.”...READ MORE
- Vaccine mandates: Tracking the policies put in place by private, public entities (thenevadaindependent.com)Higher education employee COVID vaccination rate jumps to 75 percent ahead of planned mandate (thenevadaindependent.com)
Businesses with 100 or more employees will be required to mandate vaccination or weekly testing for their workers under a new rule announced by President Joe Biden...But many Nevada businesses and public institutions have already put their own employee vaccine mandates in place, with more in the works as the federal government finalizes the new rule and fleshes out its finer points. Some have gone further by requiring vaccinations not just for employees but as a condition of entry for members of the public, including at conventions, athletic events and concerts...At the same time, some rural governments have passed resolutions banning vaccine mandates to varying degrees...READ MORE
- Under pressure to share technology, Moderna to build vaccine factory in Africa (biopharmadive.com)Moderna's search for African site set to intensify - chairman (reuters.com)
Moderna on Thursday said it will build a plant in Africa to produce shots for COVID-19 as well as other vaccines for other diseases, although it has yet to pick a site or a country for the planned factory...The Massachusetts biotech intends to spend as much as $500 million on the plant, which it claims will be able to produce as many as 500 million vaccine doses a year. Along with manufacturing the actual vaccine product, the plant will also fill vial vials and package doses, Moderna said...African nations are well behind the rest of the world in COVID-19 vaccinations. Only 7% of the continent's population has had at least one dose, compared with 66% for the U.S. and Canada, 58% for Latin America and 57% for Europe...READ MORE
- Moderna report says ‘human error’ to blame for contamination found in 3 vaccine lots from Rovi plant (fiercepharma.com)
Five weeks after Japan suspended the use of three lots of the Moderna COVID-19 vaccine, the company and its Japanese distributor Takeda have concluded that “human error” caused the presence of metallic particles in vials...The errors occurred at a Rovi manufacturing plant in Spain, which released three vaccine lots after a fourth lot from the same production series failed an inspection. The fourth and fifth lots from the series were held back...READ MORE
- Pfizer and BioNTech receive first U.S. FDA Emergency Use Authorization of a COVID-19 vaccine booster (worldpharmanews.com)Amid heated debate, FDA hands limited nod to Pfizer for COVID-19 vaccine boosters (fiercepharma.com)CDC, ACIP at Odds Over COVID-19 Boosters; CDC Aligns With FDA EUA (pharmacypracticenews.com)
Pfizer...announced that the U.S. Food and Drug Administration has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series...READ MORE