Brazil drug regulator rejects import and use of Sputnik V

The five directors of Brazil’s national drug regulator Anvisa have unanimously rejected the country’s import and use of Russian vaccine Sputnik V. The decision was made Monday evening (Apr. 26). The inoculation is produced by Russia’s Gamaleya Institute. Anvisa’s directors held an extraordinary meeting to assess requests from nine states for the purchase of the vaccine.

Anvisa Director Alex Machado Campos, who drafted the request, considered that the vaccine may present health risks. Furthermore, the documentation submitted by the manufacturer has flaws and is incomplete. Campos based his arguments on Anvisa reports unveiled at the beginning of the meeting.

Replicating virus

In his presentation, Anvisa’s Manager-General for Drugs and Biological Products Gustavo Mendes argued that the batches analyzed show adenoviruses with breeding capacity in the vaccine compound, which could pose health risks. The technology used in the manufacture of Sputnik V is that of the vector adenovirus. By means of this technique, the genetic code of Sars-Cov-2, the virus of COVID-19, is inserted into the adenovirus, which, upon being administered on human beings through the inoculation, stimulates body cells to produce an immune response.

Adenoviruses are viruses with a natural replication capacity in the human body. When used for immunization, however, this capacity must be neutralized, which is reported as not having taken place in the Sputnik shipment assessed by Anvisa.

“Among the critical points was the presence of replicating adenoviruses. This means that the virus that should only be used for carrying the genetic material of coronavirus to the human cells and promote an immune response can itself replicate. This is a serious instance of non-compliance,” Mendes said. “This replicating adenovirus was detected in all batches of the Sputnik vaccine submitted.”

This procedure, the manager said, is not in line with the development of any viral vector–based vaccine, as per parameters from US and European watchdogs. Once it reaches the human body, he pointed out, the replicating adenovirus could cause diseases and collect on specific body tissues, like on the kidney.

Documentation

In another assessment, this time regarding the vaccine manufacturers, Anvisa’s General Inspection and Monitoring Management states that the technical report with the approval of the Russian inoculation, for verifying manufacture quality control, was not submitted.

As a result, Anvisa assessed its own documents and those of other international regulators and requested in loco inspections at the two companies manufacturing the vaccine in Russia—Generium and UfavITA. This inspection was carried out last week by three experts sent by the agency. During the visit, according the Inspection Manager Ana Carolina Merino, non-compliance was detected in the manufacture of the vaccine which make an impact the product’s sterility, among other things. The inspection at Gamaleya Institute, which develops the vaccine, was denied by the Russian government.

“At this point, the risk inherent to the manufacture cannot be overcome, both for the supplies from Generium and the finished products manufactured by Generium and UfaVITA, so our managers do not recommend the import of the vaccine,” Anvisa reported.

In another report, Anvisa’s Manager-General for Products Subject to Sanitary Inspection Suzie Marie Gomes mentioned the lack of conclusive data on adverse effects in the short, medium, and long terms stemming from the use of the vaccine, which hinders product analysis. “I should also draw attention to the fact that the absence of data is also information. The absence of confirmation is considered evidence, and strong evidence, especially when we have an estimated population exposed to risks adding up to some 15 million citizens,” she declared.

In addition to the nine states that had their requests turned down, five other states and two municipalities in Rio de Janeiro await an official response by Anvisa. Altogether, these requests are said to include a total of 66 million doses, according to Anvisa itself.