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Even while pediatric COVID-19 cases remain high in the United States, there remains significant resistance by parents to vaccinate their children. Amid this reluctance, Pfizer and BioNTech have asked the FDA to authorize their vaccine for children aged 5 to 11, the companies revealed...An FDA advisory committee has scheduled a meeting on Oct. 26 to discuss authorization. The submission potentially sets up the vaccine for emergency use approval...but the companies may face a tough sell trying to convince parents that the shot is safe...Last month, only 34% of parents in the U.S. with children ages 5 to 11 said they would vaccinate them “right away,”...READ MORE

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...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

In the weeks since the Biden administration rolled out its plan to start giving COVID-19 boosters in September, medical experts have questioned the science behind the campaign and the morality of giving third doses when many in the world haven't gotten a first dose. Now, top federal health officials are pushing back...In a meeting with White House pandemic coordinator Jeffrey Zients, Centers for Disease Control and Prevention head Rochelle Walensky, M.D., and acting FDA chief Janet Woodcock, M.D., suggested that the administration scale back its booster campaign for now...READ MORE

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 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

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

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

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

Ahead of a highly anticipated meeting that could influence how soon coronavirus booster shots become widely available in the U.S., staff at the Food and Drug Administration appeared to take a neutral view of whether the agency should authorize a third dose of Pfizer's vaccine..."Some observational studies have suggested declining efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not," the reviewers said in the document, using the brand name for Pfizer's vaccine. "[B]ut FDA has not independently reviewed or verified the underlying data or their conclusions."...READ MORE