Pfizer-BioNTech Submit Request With FDA to Authorize Vaccine for Kids, Ages 5-11
Pfizer and BioNTech have officially submitted their request to the U.S. Food and Drug Administration (FDA) to authorize the use of their COVID-19 vaccine for children ages 5 to 11.
Pfizer tweeted Thursday that the companies had made the formal request with the FDA to extend their “Emergency Use Authorization.” Currently, the Pfizer-BioNTech vaccine has full FDA approval for those ages 16 and older. People between the ages of 12 and 15 can get vaccinated under the current emergency use authorization.
A lower-dose version of the Pfizer-BioNTech vaccine provided “robust” protection for children ages 5 to 11 in a clinical trial, the companies had previously announced. That data is part of their official submission to the FDA.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer Tweeted.
Pfizer-BioNTech’s application was expected. Various media reports have said that the FDA will act on approving the EAU for kids, 5-11, by early November, if not sooner. The FDA has scheduled a meeting for Oct. 26 with an independent advisory committee to discuss Pfizer-BioNTech’s request.
In the clinical trial, Pfizer-BioNTech’s two-dose regimen, containing about one-third the dose provided to people 12 and older, produced comparable antibodies to those recorded in people 16 to 25 years of age immunized with the full doses, the companies said.
U.S. Study: Pfizer Vaccine is 90% Effective Against Hospitalization for Six Months
The two-shot Pfizer-BioNTech vaccine is 90 percent effective at preventing hospitalization from COVID-19 for up to six months after the second shot, says a major new U.S. study by researchers at Pfizer and Kaiser Permanente healthcare system.
The vaccine also provides substantial protection against the highly transmissible delta variant, researchers said. However, the vaccine’s effectiveness against protecting those fully vaccinated from getting infected – or so-called breakthrough infections — declined substantially, from 88 percent during the first month after vaccination, to 47 percent after five months, according to the findings published in The Lancet  this week.
The U.S. Centers for Disease Control and Prevention (CDC) says several studies suggest vaccination is less effective at preventing infection or milder illness with symptoms over time, which is why Pfizer booster shots have been approved for older adults and those with underlying health issues
“Our results provide support for high effectiveness of (Pfizer-BioNTech vaccine) against hospital admissions up until around 6 months after being fully vaccinated, even in the face of widespread dissemination of the delta variant,” the new study concluded. “Reduction in vaccine effectiveness against (COVID-19) infections over time is probably primarily due to waning immunity with time, rather than the delta variant escaping vaccine protection.”
Researchers reviewed the electronic health records for about 3.4 million members of Kaiser Permanente Southern California, between Dec. 14, 2020, and Aug. 8, 2021.
The U.S. Food and Drug Administration (FDA) has amended the “emergency use authorization” for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a “single booster dose” to be administered at least six months after being fully vaccinated with the initial 2-shot regimen. Here’s who is eligible for the Pfizer booster shot , according to the U.S. Centers for Disease Control and Prevention.
The FDA is considering data to similarly approve booster shots of the Moderna and Johnson & Johnson vaccines. Last month the FDA authorized third doses of the Pfizer and Moderna vaccines are authorized for immunocompromised individuals .
Largest Study on Smokers and COVID-19: Smoking Significantly Increases Risk of Severe Illness, Death
Add a much higher risk of severe illness or death from COVID-19 to the many health hazards of smoking. That’s what United Kingdom researchers concluded in a first major study to combine observational and genetic data on the effects of COVID-19 on smokers.
Compared with people who never smoked, current smokers were up to 80 percent more likely to be admitted to hospital and even more likely to die from the virus, according to the study published in the British journal Thorax .
Previous studies since the pandemic on whether smoking is linked to a greater likelihood of more severe COVID-19 infection have been inconsistent, the researchers in this new study said. Most of the previous studies have been “observational.” This time, researchers said they combined observational methods with “Mendelian randomization,” which uses genetic variants to represent a risk factor — in this case variants linked to a person more likely to smoke heavily — to determine a causal relationship.
Researchers analyzed data from 421,469 participants (median age, 69 years; 55 percent women). Smoking status was obtained from primary care records and a UK patient database that included COVID-19 outcomes, hospital admissions and data on deaths up to August 2020.
“Our results complement and extend those from survey-based studies demonstrating increased odds of COVID-19 symptoms and symptomatic burden in current smokers, as well as MR (Mendelian randomization) analyses observing an association between lifetime smoking and the risk of hospitalization and respiratory failure due to COVID-19,” wrote the study’s authors.