When an FDA advisory committee meets next month to discuss a Covid-19 vaccine for young children, they will also be able to discuss the advantages of a booster shot for that age group. This week, Pfizer and BioNTech Publish preliminary data From a pivotal study evaluating the third dose in children 6 months to under 5 years of age. The results showed a strong immune response and a safety profile similar to placebo.
A phase 2/3 clinical trial testing a third dose of the vaccine enrolled 1,678 children who received a 3-microgram dose of one-tenth the adult dose of the Covid-19 vaccine at least two months after the second, two-dose schedule. In this group, the company said the third injection met the primary study goal, showing that it was roughly comparable to the results of the other two groups, the 6-month to 2-year-old cohort and the 2-to-under-5-year-old cohort. All three doses were well tolerated by study participants, and the company reported no new safety signals. In this group of young children, the vaccine was 80.3 percent effective.These latest results come about a month after the company Positive boost data reported for children aged 5 to 11. U.S. Food and Drug Administration . Authorize Last October, the main series of the group’s two shots.
Pfizer and BioNTech filed a rolling application in February seeking emergency use authorization for their Covid-19 vaccine in children aged six months to under five. The companies said they were preparing to file with the FDA seeking to add the booster to the authorization. FDA’s Vaccines and Related Biologics Committee Program Meet June 14-15 Discuss childhood vaccines. The June 14 agenda included amending the authorization of Moderna’s vaccine to include doses for the main series of injections in people aged 6 to 17. On June 15, the committee plans to discuss the Moderna vaccine for 6 months to 5 years of age, as well as the Pfizer/BioNTech vaccine for 6 months to 4 years of age.
Here are some other developments on Covid-19 over the past week:
– treat Covid-19 antiviral drug Paxlovid licensed by Pfizer Reportedly causing some patients to develop symptoms and test positive again After they apparently recovered.The resurgence of the infection, dubbed a “Covid-19 rebound,” led to the Centers for Disease Control and Prevention Post health advice Warn doctors, health officials and the public about the potential for a recurrence of the disease.
Paxlovid is designed to be taken as soon as possible after testing positive and within five days of the first symptoms. The course of treatment is five days. The Covid-19 rebound has reportedly occurred between two and eight days after the initial recovery, according to the CDC. The agency said the brief recovery of symptoms may be part of the natural history of infection with SARS-CoV-2 in some people, independent of Paxlovid treatment or vaccination status. Despite the limited information available, the CDC said case reports suggest this rebound has been milder in patients treated with Paxlovid.
“There is currently no evidence that additional treatment with Paxlovid or other anti-SARS-CoV-2 therapies is warranted in cases of suspected COVID-19 resurgence,” the CDC said.
—— Junshi Bio has data Its Covid-19 antiviral drug VV116 outperforms Pfizer’s Paxlovid, a head-to-head study shows. Phase 3 clinical trials evaluated the efficacy of both drugs in patients with mild to moderate Covid-19 who are at high risk of developing severe disease and death. According to the Shanghai-based company, patients treated with its drug had a shorter median time to sustained clinical recovery. VV116 is an oral drug designed to inhibit the replication of SARS-CoV-2. Junshi said detailed data from the study will be published in medical journals in the future.
– FDA lift Ocugen’s Phase 2/3 clinical trial testing Covid-19 vaccine Covaxin. This stop research Last month, the company decided to voluntarily suspend dosing after the World Health Organization said it found a manufacturing defect at Indian company Bharat Biotech, which developed Covaxin. Pennsylvania-based Ocugen has U.S. rights to the vaccine.
— It’s the end of the road for NRx Pharmaceuticals’ drug for Covid-19. The drug aviptadil is part of an adaptive clinical trial evaluating the treatment of patients with respiratory failure caused by Covid-19.NRx, based in Radnor, Pa., said this week that the independent data safety and monitoring committee of the NIH-sponsored study recommends Stop aviptadil research Because the results so far suggest it is unlikely to succeed. No safety concerns have been reported with NRx drugs.
– City of Hope researchers used their cancer immunotherapy expertise to develop a Off-the-shelf cell therapy for Covid-19. The Cancer Treatment and Research Center conducted immunotherapy by taking a type of immune cell called a natural killer cell and engineering it with a chimeric antigen receptor that targets the new coronavirus’ spike protein. These cells can be frozen and stored for local use or shipped anywhere in the world.The City of Hope study is post in Nature Communications.
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