The US FDA has also authorised the use of heterologous booster dose of Covid-19 vaccines, in addition to individual Covid-19 booster shots
Moderna, J&J Covid-19 booster shots now authorised in US. (Credit: Spencer Davis from Pixabay.)
The US Food and Drug Administration (FDA) has authorised booster shots of the Covid-19 vaccines from Moderna and Johnson & Johnson (J&J) for emergency use in the US.
The US health agency has previously authorised a booster dose of the Pfizer-BioNTech Covid-19 vaccine for use in people aged 65 and above, six months after the initial vaccination.
With the current emergency use authorisation, eligible people in the US can take booster shots of three Covid-19 vaccines.
In addition to individual Covid-19 booster shots, the FDA has authorised the use of heterologous booster dose of available Covid-19 vaccines.
The heterologous dose refers to a single mix and match shot of a currently available FDA-authorised Covid-19 vaccine, following primary vaccination with a different vaccine.
FDA acting commissioner Janet Woodcock said: “Today’s actions demonstrate our commitment to public health in proactively fighting against the Covid-19 pandemic.
“As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent Covid-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorised boosters is important for continued protection against Covid-19 disease.”
According to the FDA, a booster shot of the Moderna Covid-19 vaccine, at 50µg dose strength, has been authorised for administration, six months after the primary vaccination.
It is indicated for the elder population, aged 65 and above, at-risk population aged 18 to 64 years, and for people aged 18 to 64 with regular exposure to SARS-CoV-2.
Moderna said that the FDA emergency use authorisation (EUA) is based on the totality of scientific evidence, including data analysis from the Phase 2 clinical study of mRNA-1273.
A booster dose of the single-shot J&J Covid-19 vaccine is now authorised for administration in adults aged 18 years and above, at least two months after the initial regimen.
The FDA EUA follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
The VRBPAC recommendation is based on data provided by the company, including efficacy, safety and immunogenicity data from its clinical trials and real-world evidence data.