US FDA approves updated COVID vaccines for 2026-27 season
- On Thursday, the U.S. Food and Drug Administration approved Moderna's updated Spikevax and mNEXSPIKE vaccines for the 2026-27 season, targeting the JN.1-lineage XFG subvariant of SARS-CoV-2.
- Following an expert panel's May recommendation to prioritize the XFG variant, regulators also authorized updated COVID-19 vaccines from Pfizer-BioNTech and Novavax-Sanofi on the same day.
- Moderna Chief Executive Officer Stéphane Bancel noted that COVID-19 caused up to 2.3 million outpatient visits last year. Updated Spikevax is approved for ages 6 months through 64 years with underlying conditions and all adults 65 and older.
- Myocarditis and pericarditis have occurred most commonly in males 12 years through 24 years of age following mRNA vaccination. Recipients should seek immediate medical attention for chest pain or shortness of breath within 2 weeks of vaccination.
- Beyond the United States, the Spikevax formula has already received regulatory approval in Europe, the United Kingdom, Switzerland, Singapore, and South Korea, with additional applications under review globally.
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FDA approves new COVID-19 vaccine for seniors
The Food and Drug Administration on Thursday approved COVID-19 vaccines for the 2026-27 season for people at higher risk of severe illness, including everyone 65 and older and younger people with certain underlying health conditions. The FDA approved Moderna’s vaccine for people ages 6 months and older, Pfizer’s for those ages 5 and older, and Sanofi’s for people ages 12 and older. The agency also approved a lower-dose Moderna vaccine, mNEXSPIKE…
FDA Clears Updated Pfizer, Moderna and Sanofi COVID-19 Vaccines for Older and High-Risk Americans
The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna and Sanofi targeting the XFG strain, with eligibility centered on adults 65 and older and ... The post FDA Clears Updated Pfizer, Moderna and Sanofi COVID-19 Vaccines for Older and High-Risk Americans first appeared on [your]NEWS.
FDA Approves 3 New COVID-19 Vaccines
The Food and Drug Administration on Aug. 27 approved COVID-19 vaccines from Pfizer, Moderna, and Sanofi. The new shots from Pfizer and Moderna use the messenger ribonucleic acid (mRNA) platform and target the XFG strain, a subvariant of the JN.1 variant. Regulators also cleared a COVID-19 vaccine shot from Sanofi that targets the XFG strain and does not use mRNA technology. The approval is for people aged 65 and older, as well as people aged 12 …
The new vaccines are intended primarily for the elderly and people with health problems that put them at higher risk of a more severe course of the disease.
FDA Approves Updated COVID Vaccines (With A Catch)
The New York Times reports: The Food and Drug Administration approved updated Covid vaccines on Thursday, clearing the way for manufacturers to ship doses to pharmacies and doctors’ offices. Moderna and Pfizer, which make the most commonly used Covid vaccines, are expected to begin shipping soon; Pfizer said it would do so “immediately,” and Moderna has done so within days of approval in past years. Sanofi, which distributes a non-mRNA option ca…
Fall COVID Vaccines Receive FDA Approval
New COVID shots got the green light on Thursday, but actually getting one might not be straightforward. The FDA authorized updated vaccines from Moderna, Pfizer, and Sanofi/Novavax for this fall, aimed at the XFG variant now dominant in North America, the New York Times reports. Eligibility mirrors last year's: everyone...
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