The expanded authorisation allows the use of a second booster dose of Pfizer and BioNTech’s Covid-19 vaccine in people aged 50 years and above, previously vaccinated with first booster dose of any authorised Covid-19 vaccine
US authorises two second Covid-19 booster doses. (Credit: Mufid Majnun from Pixabay)
The US Food and Drug Administration (FDA) has expanded the authorisation for Pfizer-BioNTech and the Moderna’s Covid-19 vaccines, to include a second booster dose.
The expanded authorisation allows the use of a second booster dose of Pfizer and BioNTech’s Covid-19 vaccine in people aged 50 years and above, previously vaccinated with first booster dose of any authorised Covid-19 vaccine.
It was also indicated for people aged 12 years and above, with certain type of immunocompromise, who received a first booster dose of any authorised Covid-19 vaccine.
The additional booster dose is recommended at least four months after the first booster.
A single booster dose of Pfizer and BioNTech’s Covid-19 vaccine was previously granted EUA in adults and adolescents, aged 12 and above, who received the primary vaccination.
The current expanded authorisation is expected to extend elevated levels of protection against Covid-19 for the most vulnerable populations.
The US agency has also authorised a second booster dose of Moderna’s Covid-19 vaccine for use in adults, aged 50 years and above, previously vaccinated with initial booster dose.
The second booster dose of the vaccine, also known as mRNA-1273, was also indicated for adults aged 18 years and above, with certain kinds of immunocompromise.
Moderna’s application to expand the EUA, was based on data from Israel, which showed safety and effectiveness of a fourth dose of mRNA vaccine, amid the surge Omicron variant.
Moderna chief executive officer Stéphane Bancel said: “The FDA’s endorsement of a second booster dose will allow millions of Americans to build and maintain protection against SARS-CoV-2.
“The virus continues to evolve, and we are currently on the verge of another potential wave driven by the BA.2 variant. Data continue to show that mRNA boosters remain the best defense against severe infection and death, and vaccines are a foundational part of our public health protection.
“Now, healthcare providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks.”