EU regulator determining covid-booster stance
AMSTERDAM — The European Medicines Agency reports it has started an expedited evaluation of whether to recommend a booster dose of the coronavirus vaccine made by Pfizer-BioNTech.
In a statement Monday, the EU drug regulator says it is considering whether a third dose should be given six months after people 16 and older have received two doses, “to restore protection after it has waned.”
The agency’s experts are carrying out an “accelerated assessment” of data submitted by Pfizer and BioNTech, including results from an ongoing trial in which about 300 healthy adults received a booster shot about six months after their second dose.
Pfizer has already submitted an application to the U.S. Food and Drug Administration for authorization of a third dose. The government announced last month that boosters would probably be available in late September.
Israel has already started administering booster doses and the plan is under consideration in other countries for vulnerable populations, including France and Germany.
The World Health Organization has pleaded with rich countries not to use booster doses until at least the end of September, reporting there is no scientific data that proves the shots are necessary. It claims vaccines would be put to better use in developing countries, which have received less than 2% of the more than 5 billion doses administered.
Several studies have shown that protection from authorized covid-19 vaccines against the highly infectious delta variant drops months after people have been immunized, but the shots still offer strong protection against severe disease, hospitalization and death.
The European Medicines Agency disclosed it expects to make a decision in the next few weeks.
It announced it was also reviewing the use of a third dose of the vaccines made by Pfizer-BioNTech and Moderna in people with weak immune systems. It stated those people might need an extra dose “as part of their primary vaccination” programs.
SINOVAC SUSPENDED
Brazil’s health regulator suspended the use of 12.1 million doses of the vaccine manufactured by China’s Sinovac after learning that vials containing the shots were filled at an unauthorized production base.
The suspension is for 90 days as an investigation is carried out, regulator Anvisa announced Saturday. The Butantan Institute, a Sao Paulo biomedical center that has partnered with Sinovac to fill the vaccine for local usage, notified Anvisa about the irregularity the previous day, the agency stated.
“The manufacturing unit responsible for the filling was not inspected and was not approved by Anvisa,” the regulator announced. “Thus it is necessary to adopt a temporary measure to avoid the exposure of the population to a possible imminent risk.”
Plans to distribute an additional 9 million doses of the vaccine will be halted, as they were also filled at a location that was not inspected by health officials, Brazil’s health agency stated.
The regulator said the suspensions were precautionary and not punitive. They aim to “avoid use of irregular or suspect products,” Anvisa disclosed. The lack of information about the environment at the production bases, combined with the need for vaccine shots to be made in strictly aseptic settings, persuaded officials to take the measure, according to the regulator.
Anvisa and the Butantan Institute didn’t immediately reply to requests for comment. Beijing-based Sinovac also did not immediately reply.
The suspensions add to the general confusion surrounding Brazil’s vaccine rollout, which has relied heavily on Sinovac.
Brazil’s elderly have expressed concern about the vaccine’s efficacy against the delta variant, pushing health officials to start administering third doses to older citizens in urban centers last week, despite delays in giving out second doses to the larger population, according to the Associated Press.
And though the number of shots administered to the public has increased in recent weeks, the country has fully vaccinated only 65.6 million people, or about 31% of its population, according to official figures. About 53% of the population in the United States has been fully vaccinated.
Meanwhile, Brazil has canceled deals from vaccine providers in recent weeks including 10 million doses of Russia’s Sputnik V and 20 million doses from India’s Bharat Biotech, adding to public worries about timely deliveries of second shots for the broader public.
Repeated remarks from President Jair Bolsonaro casting doubt on vaccines’ efficacy have contributed to the lower-than-hoped-for vaccination rates, local health officials have said. But even among his most ardent supporters, public demand for immunization in Brazil appears to be on the rise, The Washington Post reported last month.
Those developments have coincided with drops in new infections and deaths since earlier this year, and jumps in vaccination doses given to the public.
From March to June, about 500,000 Brazilians per week were infected with the virus, while about 21,000 died in the worst week of that period. By contrast, about 171,000 individuals were infected with the coronavirus the week of Aug. 29, while deaths numbered about 4,800, according to official figures.
In the same period, the number of shots administered has risen from less than 5 million per week in March to above 10 million in August.
Brazil has been the secondworst-hit country during the pandemic, only after the United States, with more than 20 million infections and 580,000 deaths. The U.S. has logged nearly 40 million infections and almost 650,000 deaths.