The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their shots for the upcoming fall and winter season to target the “JN.1” strain, ideally a subvariant known as LP.8.1. The decision followed a vote by FDA advisers endorsing the JN.1 lineage as the preferred target, similar to the year before. Drugmakers Moderna and Pfizer said they expect to be able to update their shots in time and, on Friday, Moderna submitted an application for an LP.8.1-targeting shot to the FDA. COVID vaccines will be handled differently under the new FDA leadership, however. Commissioner Martin Makary and top vaccine official Vinay Prasad recently set new approval standards, while on Tuesday Health Secretary Robert F. Kennedy Jr. said the Centers for Disease Control and Prevention had removed COVID shots from the recommended immunization schedule for healthy children and pregnant women.\n\nKennedy, Makary and Prasad are moving quickly to roll back COVID vaccine standards they have argued promoted overly broad use on too thin evidence. “Last year, the Biden administration urged healthy children to get yet another COVID shot despite the lack of any clinical data to support the repeat booster standard in children,” Kennedy said on the social media platform X. Removing COVID shots from the CDC immunization schedule could mean that some insurers no longer cover vaccination in healthy kids and pregnant women. Kennedy’s announcement comes ahead of a scheduled meeting of CDC advisers next month, when the expert panel is expected to vote on who should receive COVID boosters.\n\nThe FDA will be reviewing new booster shot applications under the new standards laid out by Makary and Prasad, which allow immune data to support clearances in older adults or in those with health risks, but require placebo-controlled evidence for broader OKs in healthy adults and children. At a recent meeting of an FDA advisory committee, panel members questioned whether strain updates would fall under the new framework, which would potentially lengthen the time until boosters were widely available. Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review, said he wasn’t sure during the committee’s meeting Thursday.\n\nWhile the panel unanimously voted in favor of updating shots to cover the JN.1 family, they debated whether to recommend a more specific tailoring to LP.8.1. The World Health Organization and the European Medicines Agency have both recently said monovalent shots targeting the JN.1 or KP.2 strains remain appropriate, but the EMA prefers vaccines target LP.8.1. The FDA is taking a similar approach. “Based on the totality of the evidence, FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines ... preferentially using the LP.8.1 strain,” the agency said.\n\nRegulators recently granted a full approval to Novavax’s COVID shot, but only in adults 65 years or over, and in individuals between 12 and 64 years who are high risk of severe disease. At the meeting Thursday, Novavax said updating its shot to match LP.8.1 might be more difficult, by the FDA’s guidance could give it some leeway. In an email to BioPharma Dive Tuesday, Novavax said the company and its partner Sanofi intend to provide their COVID shot for the upcoming season and are assessing input from the regulatory agencies, and will provide an update on the selected strain as soon as possible.\n\nThe FDA did not give any information on clinical trial requirements or post-licensure studies in its statement on strain selection.

FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots

The FDA recommended that COVID-19 vaccine manufacturers adjust their shots for the fall and winter season to target the JN.1 strain, specifically the LP.8.1 subvariant. This follows a vote by FDA advisers endorsing JN.1 as the preferred target. Moderna submitted an application for an LP.8.1-targeting shot, while RFK Jr. removed COVID shots from the CDC immunization schedule for healthy children and pregnant women, citing lack of clinical evidence.