EU regulator warns of 'disappointing' vaccine booster uptake
Last week, Britain’s agency that determines if medicines should be used in the National Health Service (NHS) said it recommended stopping the use of five COVID-19 treatments, including Merck & Co's's antiviral pill for high-risk patients, citing cost-effectiveness concerns. In January, the U.S. Food and Drug Administration (FDA) also limited the use of some of these treatments due to data showing reduced effectiveness against the Omicron variant.
Recent uptake of COVID-19 vaccine booster doses in the European Union has been "rather disappointing," an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter. The European average rate of re-vaccination, or receiving booster doses, was only 29% in the groups of people considered to be at highest risk, such as the elderly and immunocompromised.
"It is of concern that those most at risk of hospitalisation or severe COVID are not adequately protected," the European Medicines Agency's head of health threats and vaccines strategy, Marco Cavaleri, told a news briefing. Though there have not been major increases in COVID-19 case rates in recent weeks, Cavaleri said that could change during the colder winter months.
WHO data released late on Wednesday showed that 724,000 new COVID-19 cases were reported in the EU over the past week, down 11% from the previous week. In early October, when experts were warning of a new COVID-19 wave, the number of weekly cases reached 1.5 million. "This virus is maintaining a fast pace in its evolution, and new subvariants of Omicron and its offspring are on the rise," Cavaleri said, adding that these are more resistant to vaccines.
NEW ANTIBODY TREATMENTS NEEDED Cavaleri said it was worrisome that available antibody treatments to fight the virus in infected patients are no longer working against new subvariants.
The EMA intends to issue new guidelines for health care providers on the issue of such treatments, he said. Last week, Britain’s agency that determines if medicines should be used in the National Health Service (NHS) said it recommended stopping the use of five COVID-19 treatments, including Merck & Co's's antiviral pill for high-risk patients, citing cost-effectiveness concerns.
In January, the U.S. Food and Drug Administration (FDA) also limited the use of some of these treatments due to data showing reduced effectiveness against the Omicron variant. Cavaleri said that the EMA is in contact with companies working on next-generation monoclonal antibodies against COVID-19 to help speed up development.
The EU regulator would discuss this issue, including clinical trial design of next-generation treatments, at a meeting with the U.S. Food and Drug Administration and other international experts in December, he added. An antiviral drug that is proving effective against all COVID-19 variants and subvariants is Pfizer Inc's Paxlovid, he said. The drug has also been shown to prevent post-acute, longer-term effects of the disease, he added.
But prompt access to Paxlovid remains an issue in the EU, and the EMA is working with governments to change this, he said. The agency's chief medical officer, Steffen Thirstrup, warned that a decline in case numbers over the past few weeks should not create a false sense of security as a rebound in cases could easily put vulnerable groups at risk again.
"Although many societies have opened up and are more or less considered to be back to normal, there is still a lot of circulating virus out there," Thirstrup said. The Biden administration said earlier this month that the United States will keep in place the public health emergency status of the pandemic, instead of letting it expire in January.
Officials cited the possibility of a winter surge in COVID cases and the need for more time to transition out of the public health emergency to a private market as two factors that contributed to the decision.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)