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CHMP positive option for Pfizer-BioNTech COVID-19 vaccine in the EU

Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the administration of the Pfizer-BioNTech COVID-19 vaccine as a booster shot six months after the second dose.

CHMP, part of the EMA, has approved the use of the booster jab for individuals over the age of 18. Following the CHMP positive opinion, the European Commission (EC) will make a final decision on its update to the vaccine’s current Conditional Marketing Authorisation in the EU.

In the clinical trial data provided by Pfizer and BioNTech, the COVID-19 vaccine, Comirnaty, was found to elicit significantly higher neutralising antibody titers against SARS-CoV-2, and protection from both the Beta and Delta variants of the disease.

The companies are continuing to supply their vaccine doses around the world, and this includes sufficient batches for booster doses. The existing supply agreement with the EC and the US is not expected to cause any issues to the worldwide supply.

In August the UK ordered 35 million more Pfizer-BioNTech COVID-19 vaccines to be delivered in the second half of 2021. These vaccines were purchased both as part of preparations for booster shots to be given, as well as for any new variants that emerge in the UK.

The UK has given close to 45 million second doses, with the overall total exceeding 93 million. This latter number is set to grow as more of the most vulnerable individuals in the UK are given booster jabs six months after their second dose. This is available on the NHS for those most at risk from COVID-19.