FDA authorizes Covid-19 booster shots retooled to tackle Omicron subvariants

https://www.theguardian.com/world/2022/aug/31/covid-booster-omicron-subvariant-authrorized-fda

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Vaccines produced by Moderna and Pfizer/BioNTech approved as US prepares for vaccination campaign in fall

The US Food and Drug Administration (FDA) on Wednesday authorized retooled Covid-19 booster shots made by both Moderna and Pfizer/BioNTech to target the currently dominant BA.4/BA.5 Omicron subvariants of the coronavirus.

Both vaccines also include the original version of the virus targeted by all previous Covid shots as the US prepares for another vaccination campaign in the fall.

As a single dose, Moderna’s vaccine is authorized for those aged 18 and above. Pfizer’s two-dose candidate is for those aged 12 and above.

The US government has purchased 175m doses of the booster shots in an effort to stave off the worst effects of a potential surge in new infections as schools reconvene and people spend more time indoors as the weather grows colder.

The FDA commissioner, Robert Califf, said: “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent Covid-19 vaccine to provide better protection against currently circulating variants.”

In June, the FDA asked vaccine makers to tailor shots to the two subvariants responsible for the most recent surge in infections worldwide. The BA.5 subvariant currently accounts for more than 88% of US infections.

In a statement, the FDA said: “The authorized bivalent Covid-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against Covid-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against Covid-19 caused by the Omicron variant.”

The agency said it made its decision based off the “totality of available evidence” including “safety and effectiveness data for each of the monovalent mRNA Covid-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent Covid-19 vaccine … and nonclinical data obtained using a bivalent Covid-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the omicron variant”.

Individuals who receive the bivalent booster shot may experience side effects commonly reported by those that received monolanent Covid-19 vaccines, the FDA said.

The Centers for Disease Control and Prevention (CDC) vaccine advisory panel is scheduled to meet on Thursday to make recommendations for use of the redesigned shots. The CDC director, Rochelle Walensky, will take the recommendations into consideration before making a final decision.

Currently, 79% of the US population has received at least one dose and 67% is considered fully vaccinated. Only 33% of Americans have received a booster dose.