First Generation COVID-19 Vaccines Offer Reduced Protection Against Omicron
The European Medicines Agency (EMA) and the U.S. FDA’s Dr. Peter Marks co-chaired a meeting with international regulators who published a report on January 21, 2022, highlighting their discussions on the effectiveness of current vaccines against the SARS-CoV-2 betacoronavirus Omicron variant.
Upon reviewing data on the impact of Omicron, the meeting participants concluded that current vaccines offer less protection against infection and mild disease caused by this coronavirus variant.
However, vaccination continues to offer considerable protection from hospitalization and severe COVID-19 with Omicron, especially after a booster dose.
Furthermore, the report stated, ‘It is becoming increasingly clear that a booster dose is needed to extend COVID-19 vaccine protection.’
However, when looking at possible vaccination approaches against Omicron and other virus variants, the meeting participants agreed that administering multiple booster doses at short intervals is not a sustainable approach in the longer term.
As an example, a recent non-peer-reviewed study supported by Pfizer Inc. found three doses of the Comirnaty vaccine initially increased the magnitude and breadth of neutralization against Omicron. But at four months post-dose-3, the neutralization GMTs decreased to 820 and 171, suggesting neutralization decay kinetics against Omicron.
This finding indicates a need to develop a long-term strategy on the types of vaccines needed to manage COVID-19 in the future.
Moreover, global regulators encourage the international scientific community and vaccine developers to look at alternative vaccine approaches.
In these regulators’ view, companies should also explore the feasibility of developing bivalent or multivalent variant vaccines to determine if they offer advantages to monovalent vaccines.
As of January 24, 2022, the EMA had issued authorization for five COVID-19 vaccines, including Maryland’s Novavax Inc.’s Nuvaxovid vaccine for preventing COVID-19 in people aged 18 years and older.
The meeting participants also stressed that clinical studies should be undertaken to support new vaccines.
These studies should be designed to demonstrate that the immune response, measured as neutralizing antibodies generated by the updated vaccine, is superior to that achieved with current vaccines. And the ability of the updated vaccines to cross-neutralize other variants of concern would be an additional feature with respect to the breadth of protection provided by updated vaccines.
GAVI, the Vaccine Alliance, reported on January 12, 2022, there are 21 COVID-19 vaccines being rolled out in countries worldwide.
And there are now 137 COVID-19 vaccine candidates undergoing clinical trials and 194 candidates in pre-clinical development.
This international regulator meeting brought together delegates representing 24 members, 13 associate members, and the World Health Organization.
This global response to the COVID-19 Omicron variant workshop was organized under the International Coalition of Medicines Regulatory Authorities umbrella and took place on January 12, 2022.
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