Anvisa has suspended use of millions of doses of China’s Sinovac coronavirus vaccine in Brazil

The sanitary regulator of Brazil has suspended use of just over 12.1 million doses of the coronavirus vaccine manufactured by the Chinese company Sinovac after knowing that the vials containing the vaccines were filled on an unauthorized production basis.

The suspension is 90 days while an investigation is ongoing, he said Anvisa, the regulator, which announced the decision in a statement on Saturday. The Butantane Institute, a Sao Paulo biomedical center that has partnered with Sinovac to refill the vaccine for topical use, informed Anvisa of the irregularity the day before, the agency said.

“The manufacturing unit responsible for the filling has not been inspected and has not been approved by Anvisa“, Said the regulator in the press release. “Therefore, it is necessary to adopt a temporary measure to avoid exposing the population to possible imminent risk.”.

Plans to distribute 9 million additional doses of the same vaccine will also be halted., since they were also filled in a place that has not been inspected by health authorities, Anvisa said in the statement.

The regulator said the suspensions were preventive, not punitive. Its objective is “avoid using irregular or suspicious products“, noted Anvisa. The lack of information about the environment of the production bases, combined with the need to manufacture the vaccines in strictly aseptic environments, convinced the authorities to take the measure, Anvisa said.

Anvisa and Instituto Butantan did not immediately respond to requests for comment. Sinovac also did not respond immediately, but the Beijing-based company blamed the delivery delays on production bottlenecks and bureaucratic reasons such as export licensing.

Suspensions add to general confusion surrounding vaccine rollout in Brazil, who relied on Sinovac for several of his vaccinations.

Elderly people in Brazil have expressed concern over Sinovac’s effectiveness against the delta variant, which led the health authorities to start administering third dose to the elderly in urban centers last week, despite delays in administering second doses to the general population, according to Associated Press.

And as the number of vaccines administered to the public has increased in recent weeks, the country has only fully immunized 65.6 million people, or about 31% of its population, according to official figures. In the United States, about 53% of the population is fully vaccinated.

Meanwhile, Brazil has canceled deals with vaccine suppliers in recent weeks, including 10 million doses of Russia’s Sputnik V and 20 million doses of India’s Bharat Biotech, raising public concerns over rapid delivery of second vaccines to the general public.

Repeated statements by President Jair Bolsonaro questioning the effectiveness of vaccines have contributed to lower than expected vaccination rates, according to local health authorities. But even among his staunchest supporters, public demand for vaccination in Brazil appears to be on the rise, he reported last month. The Washington Post.

This development has coincided with the decline in new infections and deaths caused by the coronavirus since the start of this year, and with the increase in vaccination doses administered to the public.

From March to June, some 500,000 Brazilians per week were infected with the deadly virus, while some 21,000 died in the worst week of this period. In contrast, in the week of August 29, some 171,000 people were infected with the coronavirus, while the deaths were around 4,800, according to official figures.

In the same period, weekly doses of vaccines administered increased from less than 5 million per week in March to over 10 million in August.

Brazil was the second most affected country during the pandemic, behind the United States, with more than 20 million infections and 580,000 deaths. The United States has recorded nearly 40 million infections and nearly 650,000 deaths.

(C) The Washington Post.-

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