Covid-19 vaccine co-developed by Pfizer and BioNTech now available FDA Approved Suitable for children 12 to 15 years old.
The FDA decision, announced Friday, builds on an emergency use authorization granted in May 2021. The approval is based on a clinical trial testing two injections of the messenger RNA vaccine in 2,260 adolescents. The vaccine generated an immune response that was comparable to an earlier study recruiting 16- to 25-year-olds. The results of the adolescent study showed the vaccine was 100% effective in preventing Covid-19 infection, with measurements between one week and more than four months after the second injection.
All Covid-19 cases reported in the adolescent study were in the placebo group, Pfizer and BioNTech said. Of the 30 confirmed cases, the only variant of interest was the alpha variant. Efficacy analyses were conducted between November 2020 and May 2021, before the rise of delta and omicron variants.
current data Data from the Centers for Disease Control and Prevention showed that the highest circulating version of the virus was the BA.5 subvariant of omicron, accounting for 53.6% of the total. The BA.2.12.1 and BA.4 subvariables accounted for 27.2% and 16.5% of the total, respectively. The Centers for Disease Control and Prevention reports that 78.4% of the U.S. population has received at least one dose of the vaccine; 67% are fully vaccinated.
The Pfizer and BioNTech Covid vaccines, marketed under the name Comirnaty, carry the rare risk of side effects of myocarditis, or inflammation of the heart. Adverse events in the adolescent study were broadly consistent with other clinical data on the vaccine, the companies said. This safety profile remained unchanged at the six-month follow-up after the second dose.
Here are other recent Covid-19 news updates:
– Messenger RNA vaccine developer CureVac is suing German company BioNTechclaiming its Covid-19 vaccine infringes key patents. According to CureVac, the patents cover the engineering of mRNA molecules and formulations used in vaccines. BioNTech maintains that its work is original and will defend itself against allegations of infringement.
– Pharmacists now have the right to Prescribe Pfizer’s antiviral drug Paxlovid. Previously, pharmacists were required to refer patients to physicians, nurses or physician assistants who were licensed or authorized to prescribe medication. In explaining the reasons for the change, FDA says Because Paxlovid treatment must begin within five days of the onset of symptoms, allowing pharmacists to prescribe the drug should make it easier for patients to get the drug in a timely manner. Lagevrio from Merck doesn’t get the same flexibility.This FDA tells Fierce Pharma The side effect profile of Merck’s drugs is one of several factors that require consultation with traditional prescribers.
— From 2020 to 2021, the acceptance rate of the Covid-19 vaccine increased from 71.5% to 75.2%. result From a June 2021 survey of more than 23,000 people in 23 countries. One of the goals of the study was to identify the drivers of vaccine hesitancy. One of the factors of indecision is safety concerns and mistrust of vaccine science. The research, conducted by the CUNY Graduate School of Public Health and Policy, the Barcelona Institute for Global Health, Dalhousie University and the University of Calgary, is published in the journal Nature Communications.
— In other news about a Covid-19 vaccine for adolescents, Novavax’s European conditional marketing authorization for its protein vaccine Nuvaxovid is Expand to 12 to 17 year olds. The European Commission’s action is based on the results of a Phase 3 study that recruited 2,247 adolescents in the United States. The Novavax vaccine has not been authorized by the FDA in any age group.
Brii Biological Sciences roll out Its Covid-19 antibody combination drug in China. Late last year, Chinese regulators approved the drug, a pairing of ambavizumab and romlucilumab, to treat adults at risk of progression to serious disease or death. In children 12 to 17 years old, the drug is conditionally approved.
– FDA reject Emergency Use Authorization granted to NRx Pharmaceuticals for Covid-19 drug aviptadil. In May, the independent data and safety monitoring committee Advised to stop clinical trials of drugs Because the results so far suggest the study won’t be successful. Radnor, Pa.-based NRx had sought authorization to treat a group of patients who showed progress when the drug was used with the FDA-approved Gilead Sciences antiviral drug Remdesivir.
Public Domain Image Courtesy of FDA
