With FDA's action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors' offices, pharmacies and other vaccination sites. Kids will get two shots, three weeks apart.
The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days.
The vaccination requirement for foreign nationals comes as the White House has moved to impose sweeping vaccination-or-testing requirements.
The company said Tuesday it provided health regulators with data from a recent study of its vaccine in children 5 to 11 years old.
The FDA authorized booster doses for Americans who are 65 and older, younger adults with underlying health conditions and those in jobs that put them at high risk for COVID.
Pfizer COVID-19 vaccine is safe for children aged 5-11, confirms clinical trial results, reports AFP
An influential federal advisory panel overwhelmingly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.
Currently, Pfizer's mRNA Covid vaccine is available in two packages: one with 450 doses and another with 1,170. But the vaccine's cold storage requirement limits where and for how long they can be kept, making it challenging for smaller facilities to store high quantities of the vaccine without wasting doses.
Even as the approvals are pending, the Joe Biden administration has announced plans to offer third doses to people who received the Pfizer and Moderna shots.
The case has been referred to the coroner and the cause of death has not yet been determined, the health ministry said.
Pfizer’s vaccine — along with those from Moderna and Johnson & Johnson — still underwent testing in tens of thousands of people to establish safety and effectiveness against COVID-19.
The U.S. gave full approval to Pfizer’s COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet.
Researchers from the Mayo Clinic in Minnesota, US, found that the Pfizer-BioNTech vaccine was only 42 percent effective against infection in July, while the Moderna vaccine was only 76 percent effective.
Antibody levels against the Delta variant in people aged 18 to 55 who receive a third dose of the Pfizer/BioNTech vaccine are greater than five-fold than following a second dose, according to data posted at the company's teleconference, Xinhua reported.
The study, led by researchers of University College London, showed that waning effect of the vaccine doses were consistent across all groups of people regardless of age, chronic illnesses or sex.
The study, led by the University of Oxford, in collaboration with the Universities of Birmingham, Newcastle, Liverpool, Sheffield, and supported by the UK Coronavirus Immunology Consortium, is one of the most comprehensive studies into the immune response generated by the Pfizer COVID-19 vaccine to date.
There was a heavy police presence in Sydney, including mounted police and riot officers in response to what authorities said was unauthorized protest activity. Police confirmed a number of arrests had been made after objects were thrown at officers.
US regulators on Monday added a new warning to Johnson & Johnson's COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it's not entirely clear the shot caused the problem.
Pfizer says it plans to meet with top US health officials Monday to discuss the drugmaker's request for federal authorization of a third dose of its COVID-19 vaccine.
Research from multiple countries shows the Pfizer shot and other widely used COVID-19 vaccines offer strong protection against the highly contagious delta variant, which is spreading rapidly around the world and now accounts for most new U.S. infections.
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