Anvisa says there is no documentation to release Janssen doses donated by the US

Anvisa says there is no documentation to release Janssen doses donated by the US

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Anvisa says there is no documentation to release Janssen doses donated by the US

Anvisa (Agency for Sanitary Surveillance) said this Wednesday (June 30, 2021) that the Ministry of Health did not send all the necessary documentation to release 2 million doses of Janssen donated by the United States. The vaccines arrived in the country on Friday (June 25, 2021).

“The Ministry of Health presented documentation regarding the load of 947,650 vaccine doses for Covid-19 from the Janssen manufacturer sent to Brazil and Anvisa released the batch for distribution purposes. However, the Agency has not yet received documentation regarding the other load, of 2,052,350 doses.” the regulatory agency said in a statement.

In all, the US government donated 3 million doses of the vaccine to Brazil. The immunizing agent is applied in a single dose.

According to the statement, the immunizers were landed with priority by Anvisa on the same date they arrived in the country, “under the commitment of the importer and faithful custodian of the cargo, which is the Ministry of Health itself, to provide the necessary complementary information prior to the distribution of vaccines”.

This Wednesday afternoon, São Paulo Governor João Doria (PSDB) stated that Janssen vaccines donated by the United States have not yet been distributed to the States. São Paulo would receive 678,000 doses of the immunizing agent, but the government says it has not yet received the doses.

“The government of the State of São Paulo requests the Ministry of Health to immediately release 678,000 Janssen vaccines that have been stored in the Ministry’s warehouse since June 25”, he said.

O power360 contacted the Ministry of Health, but received no response until the publication of this report.

Here is the full note published by Anvisa:

“This Wednesday, 06/30, the Ministry of Health presented documentation regarding the load of 947,650 doses of vaccine for Covid-19 from the manufacturer Janssen sent to Brazil and Anvisa released the batch for distribution purposes. However, the Agency has not yet received documentation regarding the other load, of 2,052,350 doses.

Vaccines donated by the United States to Brazil, which arrived at the Viracopos International Airport, in Campinas (SP) between June 25 and June 26, were cleared with priority by Anvisa on the same date they arrived in the country, under commitment the importer and trustee of the cargo, which is the Ministry of Health, to provide the necessary complementary information prior to the distribution of vaccines.

Anvisa had authorized the import licensing of the two cargoes, under term of custody and responsibility – a procedure in which the inputs are stored in the Ministry of Health’s logistics center, awaiting additional documents necessary for definitive release and use. This modality is conventional and always depends on the importer’s petition.

Anvisa clarifies that it has acted with agility and contributed to the rapid availability of vaccines to Brazilian society. As part of the fight against the Covid-19 pandemic, all applications for licenses to import medicines and vaccines are analyzed with utmost urgency and absolute priority by the Agency.”

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