RIO DE JANEIRO – Brazil's health regulator cited safety concerns while rejecting several states' requests to import almost 30 million doses of Russia's Sputnik V vaccine, prompting criticism from the Russian government.
The five-person board of the Brazilian Health Regulatory Agency unanimously decided late Monday that consistent and trustworthy data required was lacking for approval of the requests from 10 states, according to a statement. Another four states and two cities have also sought authorization to import the vaccine.
The agency, known as Anvisa, said there were faults in all clinical studies of the vaccine’s development, as well as absent or insufficient data.
The agency statement said that analysis indicated that the adenovirus on which the vaccine is based has the capacity to replicate, which could cause sickness or death, particularly among those with low immunity or respiratory problems. The Russian fund overseeing the vaccine's marketing globally denied the claim.
“We will never permit, without the existence of due proof required, millions of Brazilians to be exposed to products without the due proof of their quality, safety and efficacy or, at minimum, in the face of the grave situation that we’re living through, a favorable cost-benefit relationship,” Anvisa’s president Antônio Barra Torres said in the statement.
Anvisa’s decision doesn’t affect a separate request from Brazilian company Uniao Quimica for emergency use authorization of Sputnik V produced locally, according to an emailed statement from Anvisa’s press office.
Still, it came as a blow to Russia’s efforts to promote worldwide adoption of the vaccine, whose exports have helped it regain diplomatic footholds in countries where relationships had languished.
“We need additional information on what this lack (of data) means, because there’s already more than enough data," Kremlin’s spokesperson Dmitry Peskov told reporters in a daily briefing.