The rolling review is initially based on chemistry, manufacturing, and controls (CMC) data, which the vaccine manufacturers shared with EMA this month, with additional data to be added to the rolling submission
Pfizer and BioNTech are evaluating several variant-adapted vaccines. (Credit: Mat Napo on Unsplash)
Pfizer and BioNTech announced that the European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of their Covid-19 vaccine.
The rolling review is initially based on chemistry, manufacturing, and controls (CMC) data, which the vaccine manufacturers shared with EMA this month.
The emerging clinical data, including data on immunogenicity against Omicron and its subvariants, will be added to the rolling submission, said Pfizer.
In addition, the companies intend to submit data supporting a potential variant-adapted vaccine to the US Food and Drug Administration (FDA) in the coming weeks.
EMA stated: “The composition of adapted COVID-19 vaccines will ultimately depend on recommendations of public health authorities and the World Health Organization (WHO) as well as the considerations of regulatory bodies such as EMA and other members of the International Coalition of Medicines Regulatory Authorities (ICMRA).
“These bodies are working closely together to determine the appropriate strains for adapted Covid-19 vaccines.
“Starting this rolling review is one of the ways authorities in the EU are working to ensure that EU Member States have timely access to adapted COVID-19 vaccines they may need to combat current and emerging SARS-CoV-2 variants.”
Pfizer and BioNTech are currently assessing several variant-adapted vaccines.
The companies intend to discuss the composition of the variant-adapted vaccine with global regulatory bodies to determine a potential vaccine booster approach.
Pfizer-BioNTech Covid-19 vaccine has received the US FDA Emergency Use Authorization (EUA) for active immunization against Covid-19, in individuals aged five years and older.
The two-dose primary series of the vaccine has been approved for use in individuals aged five years and above.
A third primary series dose was also approved in the same age group, with certain kinds of immunocompromise.
Pfizer-BioNTech Covid-19 vaccine was also approved as a single booster dose in children aged as young as five to 11 years, who previously received a primary series.