GlaxoSmithKline(GSK.US)RSV vaccine receives FDA expanded approval, adding 21 million adults to the market to compete with Pfizer

GlaxoSmithKline(GSK.US)-developed RSV( (respiratory syncytial virus) vaccine Arexvy), which is used to prevent respiratory syncytial virus (RSV)(, received expanded approval from U.S. regulators on Friday, March 13, thereby extending its coverage to all high-risk adult populations. Given that the Trump administration is stepping up scrutiny over vaccination-related matters, this news is undoubtedly like a “comforting reassurance” for pharmaceutical companies.

The vaccine had previously been approved by the U.S. Food and Drug Administration)FDA( for all adults aged 60 and above, as well as for people aged 50 to 59 who have at least one disease condition that increases the risk of severe infection. This newly granted approval will add about 21 million adults in the U.S. to those eligible for vaccination, placing Arexvy’s RSV)vaccine on a level playing field with Pfizer(PFE.US)’s similar vaccine in the market.

As it is understood, RSV( (respiratory syncytial virus)) is an especially dangerous virus that can be fatal, posing a particularly serious threat to infants and the elderly. In the U.S. alone, tens of thousands of people are hospitalized each year due to infection with this virus. Among them, about 17,000 adults aged 18 to 49 are hospitalized annually in the U.S. due to RSV infection. The vaccine developed by GlaxoSmithKline(GSK) uses an adjuvant component provided by Agenus; its role is to enhance the human immune system’s response.

For supporters of the vaccine, the decision to approve this vaccine is undoubtedly a major positive development. Previously, senior health officials in the Trump administration had long been blaming vaccination efforts, repeatedly, and had also kept raising the standards and thresholds for future vaccine approvals. Worth noting is that the former head of the FDA( vaccine division, Vinay. Prasad, announced that he will step down next month, ending his turbulent second term; and the decision to approve this vaccine was announced exactly one week after he made that announcement.

The approval of this vaccine was based on a study involving fewer than 1,000 participants. The study found that the immune response generated by the vaccine in the 50 to 59 age group was roughly comparable to that in the 60-and-over group that had already been approved for vaccination. In addition, 600 participants received follow-up observation to ensure the vaccine’s safety.

Next, the U.S. Vaccine Advisory Group)ACIP( will begin considering whether to include the 50 to 59 age group in the vaccination recommendation scope for the Arexvy vaccine. This group plays an important role in helping determine whether a vaccine is included in insurance coverage. Previously, it voted to expand the RSV vaccine vaccination recommendation scope to adults aged 50 to 59. However, the group has not yet made a decision on whether to recommend repeat vaccination, which has caused the vaccine market to shrink amid uncertainty about the prospects for repeat vaccination.

The committee will hold a meeting next week, but so far it has not clearly indicated when it might consider expanding the RSV vaccine vaccination recommendation scope. It needs to be explained that here, “expanding” refers to expanding the scope of repeat vaccination recommendations, not expanding the age range for vaccination.