After Anvisa suspend lots of CoronaVac, Butantan rejects ‘alarmism’ and emphasizes its own quality control | São Paulo

After the National Health Surveillance Agency (Anvisa) announced this Saturday (4) the banning at least 25 batches of CoronaVac vaccine, prohibiting the distribution and use of bottled doses in a factory not approved by the agency, the Butantan Institute said that “Anvisa’s measure should not cause alarmism“. About 12 million doses were affected by the suspension.

In a statement, Butantan declared that it was the institute itself that warned Anvisa for “extreme precaution” and that it “invites Anvisa’s top management to get to know Sinovac’s factory facilities” in China again (read the full note below).

Butantan also defended that the provisionally suspended doses “are attested by the rigorous quality control of Butantan”.

“All batches released by the institute are in the possession of the Ministry of Health, as signed in the contract. We reaffirm, however, that all doses that left the factory are certified by the rigorous quality control of Butantan”, said the institute in a statement .

The Institute also said that it forwarded to Anvisa, 15 days ago, the necessary documentation for the certification of the production process in which the doses now banned were made.

On Friday (3), Anvisa was informed by Butantan that pharmaceutical company Sinovac, manufacturer of vaccine inputs, sent 12,113,934 doses to Brazil, in the vial presentation (single dose and two doses).

However, according to the agency, the factory responsible for filling these doses was not inspected and approved in the Emergency Use Authorization granted to CoronaVac.

The Butantan Institute also informed, according to the Agency, that another 17 batches, also bottled at the place not inspected by Anvisa, and that add up to 9 million doses are in the process of sending and release to Brazil.

O G1 had access to the letter sent this Friday (3) to Anvisa. In the document, the director of Butantan, Dimas Covas, says that technicians from the Institute analyzed the information available in the lots and pointed out the safety and quality of the vaccines produced at the factory, which has not yet been inspected.

In the text, Dimas Covas requests authorization for vaccines to be applied on an emergency basis, so as not to compromise the national immunization program.

Anvisa provisionally suspends batches of CoronaVac vaccine

Anvisa provisionally suspends batches of CoronaVac vaccine

“We would also like to ask this I. Cabinet to authorize the use, on an exceptional basis, of the vaccine doses that are already distributed, as well as the authorization to use the doses that are still in the process of being released and sent to Brazil (lots listed in the annex), so that there is no compromise in the continuity of the population’s vaccination”, says the director of Butantan in the letter.

The agency informed that, this Saturday, it will publish two Resolutions (RE) in the Extra Edition of the Federal Official Gazette determining: the “precautionary interdiction prohibiting the distribution and use of batches in the unapproved plant”; “the prohibition of distribution of batches not yet distributed”.

See the full note from the Butantan Institute:

Butantan clarifies that Anvisa’s measure should not cause alarmism. It was the Institute itself that, out of a commitment to transparency and extreme precaution, communicated the fact to the agency, after attesting to the quality of the doses received. This ensures that immunizers are safe for the population.

The Butantan Institute forwarded to Anvisa 15 days ago all the necessary documentation for the certification of the production process in which these doses were made. Therefore, he is convinced that it will be granted soon. If necessary, you can complement the request with more data, including Sinovac, if the agency deems it necessary.

The Butantan vaccine is the safest immunizing agent available to the National Immunization Program (PNI), because of its inactivated virus platform.

All lots released by the institute are in the possession of the Ministry of Health, as signed in the contract. We reaffirm, however, that all doses that left the manufacturing unit are attested to by Butantan’s strict quality control.

He also informs that 6 million doses of the Butantan vaccine, which are part of a batch of 12 million immunizing agents formulated at the industrial site in the west of São Paulo, were awaiting release from Anvisa. Last Thursday (2), the regulatory body released them and they were issued on Friday (3).

This request for release to the regulatory body was due to a change in one of the stages of the vaccine formulation process, which may occur during manufacturing. The factory where the formulation and filling of CoronaVac is made are all certified by Anvisa, since the end of 2020.

Butantan invites Anvisa’s top management to get to know Sinovac’s factory facilities in China again, and reinforces its commitment to public health, which has been proven throughout its 120 years of history.