The backers of Russia’s Sputnik V vaccine say they are suing Brazilian regulators over their criticism of the jab’s quality, which includes references to flaws in product development.
In a worrying sign for the Russian vaccine’s future, Brazil’s national health surveillance agency, Anvisa, banned imports of Sputnik V on Wednesday, denying requests from more than a dozen state governors.
The watchdog gave many reasons for doing so. Some were more startling than others. The headline-grabbing reason relates to the adenovirus-vector technology used in Sputnik V, though it does not mean there is a problem with that technology per se. AstraZeneca and Johnson & Johnson use the same technology in their vaccines.
Sputnik V uses what is supposed to be a weakened version of a common cold virus, which like SARS-CoV-2 is a coronavirus. This prompts the immune system to get ready to fend off other coronavirus infections.
According to Anvisa, doses of Sputnik V contain a virus that is capable of replicating, meaning it could actually cause a cold—bad news for people with respiratory problems or weak immune systems. This may indicate a problem with Sputnik V’s manufacturing, rather than with the fundamentals of adenovirus-vector vaccines.
The Brazilian agency said product development flaws had been identified in all three stages of Sputnik V’s clinical trials. It also said there wasn’t enough data on quality control or safety and effectiveness.
Anvisa sent inspectors to Russia to examine the two plants where the Brazil-bound doses were to have been manufactured, and they weren’t impressed. They also weren’t impressed with what they didn’t see, namely the facilities of the Gamaleya Institute that developed Sputnik V; Anvisa said they hadn’t been let in.
Angry Twitter account
This is not the first time Anvisa has rejected an importation request for a COVID vaccine—it did the same earlier this month for Bharat Biotech’s Covaxin jab, pointing to sterilization issues at the Indian factory producing the vaccine, as well as to data and documentation deficiencies.
But this time around the Russian Direct Investment Fund (RDIF), which bankrolls Sputnik V, went ballistic.
Seizing on the fact that Anvisa didn’t analyze any Sputnik V samples itself—it typically analyzes the vaccine developer’s own testing data—RDIF tweeted from its often belligerent Sputnik V Twitter account that “Sputnik V is undertaking a legal defamation proceeding in Brazil against Anvisa for knowingly spreading false and inaccurate information.”
In a statement, the fund said the decision to deny the import requests was “of a political nature and has nothing to do with the regulator’s access to information or science.” It said the Gamaleya Institute’s quality-control processes ensure no replication-competent adenoviruses “can exist in Sputnik V vaccine,” and no such viruses “were ever found in any of the Sputnik V vaccine batches that have been produced.”
It also said Anvisa’s team had been given “all the relevant scientific documents and data as well as direct access to the Gamaleya Center scientists in charge of the vaccine development”—which is, of course, not quite the same thing as direct access to Gamaleya itself.
The statement also said Anvisa’s claims “have no scientific grounds and cannot be treated seriously in the scientific community and among international regulators.” It might be too late for that, with the likes of Georgetown virologist Angela Rasmussen saying Anvisa’s decision “raises questions about the integrity of the manufacturing processes.”
The criticism is embarrassing for the Sputnik V team, especially as it has in the past used claims of superior filtration technology to trash AstraZeneca and J&J, when their vaccines were potentially linked to a rare clotting disorder.
This is also not the first time a national regulator has pushed back against Sputnik V.
Earlier this month, the Slovakian drug regulator, ŠÚKL, said the RDIF had sent the country doses that weren’t the same as the Sputnik V doses that had been shown to be highly effective in a peer-reviewed study, or the doses that are being evaluated by the European Medicines Agency.
Again, the RDIF reacted angrily, telling Slovakia to return hundreds of thousands of already delivered doses because of contract violations. It accused the Slovakian regulator of “an act of sabotage,” on the basis that it had not tested the doses in a particular laboratory.
More health care and Big Pharma coverage from Fortune:
- Moderna is working toward a single shot for both COVID and flu protection
- Pfizer’s COVID-19 treatment pill could be available by year’s end
- West Virginia sets new bar for COVID vaccine incentives with $100 reward
- Americans can travel to Europe this summer. But will they want to?
- The 2021 Fortune/IBM Watson Health 100 Top Hospitals
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