Omicron-Specific COVID Vaccines Could Improve Protection As Boosters: European Medicines Agency

When administered as a booster, coronavirus vaccinations modified to incorporate the Omicron variant strain can improve protection, according to the European Medicines Agency and other worldwide health regulators on Friday.

The European Medicines Agency (EMA) announced that global regulators have agreed on essential principles for upgrading COVID-19 injections to respond to developing variations.

While existing coronavirus vaccinations continue to give adequate protection against hospitalisation and death, the organisation claims that vaccine efficacy has declined as the virus has changed.

As a result, an Omicron-specific or bivalent booster vaccination containing both the new strain and the original coronavirus strain could “improve and extend” protection, according to an EMA statement.

The declaration clearly mentions mRNA vaccinations. Pfizer Inc and Moderna Inc have both been testing retooled versions of their vaccines with the Omicron variant.

Vaccines containing additional versions, such as the Beta variant, may be explored for use as boosters if clinical trial data show an appropriate level of neutralisation against Omicron and other variants of concern, according to the statement.

It follows the World Health Organization’s recommendation that Omicron-specific boosters could restore protection against new coronavirus strains.

However, it falls short of the position of the Food and Drug Administration (FDA) in the United States, which stated that it would seek the inclusion of the newer BA.4 and BA.5 strains of Omicron, which are currently driving a surge in new infections internationally, in any new shots for domestic use.

On Tuesday, the leader of a WHO advisory committee that reviewed the modified shots stated that the group favoured BA.1-based boosters because the variant is more distinct and may elicit a broader response than the more recently circulated subvariants.

In an interview, top U.S. FDA official Peter Marks stated that other countries’ regulators were seriously considering using new boosters based on the BA.1 Omicron variant that caused the massive surge in cases last winter, because those shots could be available sooner than the BA.4/5 based booster that the US plans to use.

The EMA stated that more information would be provided in the coming days.

(Adapted from

Categories: Regulations & Legal, Strategy, Sustainability, Uncategorized

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