After the Omicron variant became available, the head EMA stated that a contingency strategy had been created to expedite the approval of the improved vaccine.
The head of the EU Drug Regulatory Agency issued a reassuring tone after reports claimed that Omicron, a latest coronavirus variant, has infected many countries.
Emerkuk, the executive Director of the European Medicines Agency said Tuesday in a testimony before the European Parliament’s Health Committee that “we know that the virus is going to mutate.”
Cook stated that regulations have been in effect since February to allow vaccine manufacturers to speed up the approval process for improved coronavirus vaccines.
Cook noted that any new variant requires a careful evaluation to determine whether it really needs an improved vaccine. The large number of mutations found in the Omicron variants—especially in the key spike protein—has raised concerns that it may be able to bypass the immunity conferred by existing vaccines.
Cook stated that they have created an emergency plan and are working with other regulatory agencies, the World Health Organization and European Center for Disease Control and Prevention in preparation for any worst-case scenario.
The head of EMA added that compared with last winter, the EU has a much better situation and has “more tools”.
She explained the vaccine in detail, pointing to Ireland, her home country where 93% of the adult population is vaccinated. Ireland’s COVID-19 death toll is 15 per million, and there are 250 per million registered in two unnamed EU countries with vaccination rates below 50%.
Cook stated that approval for Novavax could occur in “a few weeks”. He also said that regulators are working on a strategy to mix and match boosters. This strategy may be available soon. The vaccine will be released on weekends.
Cook stated that EMA was working with member countries to provide advice on urgent use of antiviral medications developed by Merck or Pfizer prior to EU-level marketing authorization.