The Covid-19 vaccine co-developed by Pfizer and BioNTech now has FDA approval for children 12 to 15 years of age.

The FDA decision announced Friday builds on the emergency use authorization that was granted in May 2021. The approval is based on a clinical trial testing the two-shot messenger RNA vaccine in 2,260 adolescents. The immune response produced by the vaccine was comparable to the results of an earlier study in young adults between the ages of 16 and 25. Results in the adolescent study showed that the vaccine was 100% effective in preventing Covid-19 infection, measured between one week and more than four months after the second shot.

All cases of Covid-19 reported in the adolescent study were in the placebo group, Pfizer and BioNTech said. Of these 30 confirmed cases, the only variant of concern identified was the alpha variant. The efficacy analysis was conducted between November 2020 and May 2021, which was before the rise of the delta and omicron variants.

Current data from the Centers for Disease Control and Prevention show that the top circulating version of the virus is omicron’s BA.5 subvariant, which accounts for 53.6% of the total. The BA.2.12.1 and BA.4 subvariants account for 27.2% and 16.5% of the total respectively. The CDC reports that 78.4% of the U.S. population has received at least one vaccination dose; 67% has been fully vaccinated.

The Pfizer and BioNTech Covid vaccine, which is marketed under the name Comirnaty, comes with a rare side effect risk of myocarditis, or heart inflammation. The companies said that adverse events in the adolescent study were generally consistent with other clinical data for the vaccine. That safety profile was maintained through six months of follow-up after the second dose.

Here’s a look at other recent Covid-19 news developments:

—Messenger RNA vaccine developer CureVac is suing fellow German company BioNTech, claiming its Covid-19 vaccine infringes on key patents. According to CureVac, those patents cover the engineering of mRNA molecules and the formulations used in the vaccines. BioNTech maintains that its work is original and it will defend itself against the infringement allegations.

—Pharmacists now have the authority to prescribe Pfizer antiviral drug Paxlovid. Previously, pharmacists needed to refer patients to physicians, nurses, or physician assistants who are licensed or authorized to prescribe drugs. In explaining the reason for the change, the FDA said that because Paxlovid treatment must begin within five days of the start of symptoms, allowing pharmacists to prescribe the drug should make the drug more accessible to patients in a timely manner. Lagevrio, from Merck, was not afforded the same flexibility. The FDA told Fierce Pharma that the Merck drug’s side effect profile is one of several factors that require consultation with a traditional prescriber.

—Acceptance of Covid-19 vaccines grew from 71.5% to 75.2% from 2020 to 2021. The results are from a June 2021 survey of more than 23,000 people in 23 countries. One of the goals of the study was to identify drivers of vaccine hesitancy. Safety concerns and mistrust of vaccine science were among the factors behind hesitancy. The study, conducted by the CUNY Graduate School of Public Health and Policy, the Barcelona Institute for Global Health, the Dalhousie University and the University of Calgary, was published in the journal Nature Communications.

—In other news about Covid-19 vaccines for adolescents, Novavax’s European conditional marketing authorization for its protein-based vaccine, Nuvaxovid, was expanded to those ages of 12 through 17. This European Commission action was based on the results of a Phase 3 study that enrolled 2,247 adolescents in the U.S. The Novavax vaccine has not yet received FDA authorization in any age group.

—Brii Biosciences launched its Covid-19 antibody combination drug in China. Late last year, regulators in China approved the medicine, a pairing of amubarvimab and romlusevimab, as a treatment for adults who are at risk of progression to severe disease or death. In children age 12 to 17, the drug has conditional approval.

—The FDA declined to grant emergency use authorization to an NRx Pharmaceuticals Covid-19 drug, aviptadil. In May, an independent data and safety monitoring board recommended stopping clinical tests of the drug because the results to date suggested the study would not succeed. Radnor, Pennsylvania-based NRx had sought the authorization for treating a subgroup of patients who were showing progress when the drug was also used alongside the FDA-approved  Gilead Sciences antiviral Remdesivir.

Public domain image by the FDA