The EU drug watchdog said Thursday that it would decide in early October whether to approve the Pfizer / BioNTech COVID-19 vaccine booster for more than 16 seconds.
According to the European Medicines Agency (EMA), decisions on further jabs for both the Pfizer and Modana vaccines for at-risk people and the elderly will be made at the same time.
Protection against the coronavirus has been shown to diminish in the months following the first jab, head of the Amsterdam-based regulatory agency. vaccination Strategy Marco Cavaleri told a press conference.
“Available data show that immunity to COVID-19 from the first vaccination has declined over time, and protection from infection and symptomatic disease has diminished in different parts of the world,” Cavaleri said. Said.
As a result, EMA is currently evaluating Pfizer’s application to use a third booster immunotherapy for people 16 years and older at least 6 months after the second dose.
“Unless supplementary information is needed, the results of this assessment are expected in early October,” Cavaleri said.
EMA experts also said that “evidence is emerging” about the need for boosters shortly after the first jab for people with a weakened immune system who are “unresponsive” to the first vaccination. I did.
Elderly hospitalization rates were beginning to rise as the first jabs were worn down, Kavaleri said.
According to Cavaleri, Watchdog will “consider whether certain recommendations can be included in product information by early October” for Modana and Pfizer vaccines for such people. is.
Some EU member states have begun to provide boosters to people at risk prior to approval, before COVID cases could surge in the winter, Cavaleri said.
He added that the EMA “acknowledged and understood” this decision.
Watchdog, meanwhile, expects to make a decision on the approval of the COVID vaccine. Young children In the next few months.
Pfizer plans to submit data on trials for children aged 5 to 11 in early October and Moderna in November, both of which are likely to be decided after four weeks, Cavaleri said. ..
Regulators are currently approving four vaccines for use in the EU in 27 countries. Pfizer and Moderna using messenger RNA technology, and AstraZeneca and Johnson & Johnson using viral vector technology.
So far, only Pfizer and Moderna have been approved for use in children over the age of 12.
© 2021 AFP
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