Approval by the European Medicines Agency would add another
vaccine to the EU’s armory against COVID-19 as the bloc ramps up administering
booster shots and some countries are preparing to deliver shots of Pfizer’s
vaccine to children ages 5 to 11.
Last month, the EU’s executive commission approved a
contract with Valneva for member nations to buy almost 27 million doses in
2022. The contract also included the possibility to adapt the vaccine to new
variants of the coronavirus and to purchase up to 33 million more doses in
2023.
A rolling review is an accelerated way of assessing new
drugs that allows European Medicine Agency experts to look at data from ongoing
studies as they become available. Once sufficient data is available, the
company can submit a formal application for EMA marketing authorization.
The Amsterdam-based agency did not give a time frame for
possible approval of the Valneva vaccine.
In September, the U.K. government canceled an agreement with
Valneva, partly because it was clear the company’s COVID-19 vaccine wouldn’t be
approved by British regulators, the U.K. health secretary said.
The EMA is now carrying out rolling reviews of four COVID-19
vaccines, including Russia’s Sputnik shot and China’s Sinovac. -AP
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