MANILA—US Health and Human Services Secretary Alex Azar on Wednesday cautioned against a new Russian-made COVID-19 vaccine, citing the lack of transparency on clinical trials conducted prior to government approval.
The vaccine, which Philippine President Rodrigo Duterte had volunteered to be publicly injected with, has yet to go through crucial late-stage trials where it will be tested among thousands of people for safety and efficacy.
“This is not a race to be first,” Azar told journalists in a teleconference, noting that 2 of the 6 vaccines, which the US was eyeing for eventual distribution, began Phase 3 trials weeks ago and which “the Russian vaccine is now only beginning.”
“It's important that we provide safe, effective vaccine and that the data be transparent,” he said.
The Russian government green-lighted its Sputnik V vaccine, claiming to be the world's first against the new coronavirus, which has infected more than 2.2 million people and killed 739,898.
President Vladimir Putin said the vaccine "passed all the needed checks," and that his daughter was among those inoculated.
But the speed with which the vaccine got regulatory approval had experts worried that Russia skipped important steps in vaccine development for the sake of global acclaim.
The World Health Organization (WHO) said the process includes "a rigorous review and assessment of all the required safety and efficacy data."
"Data from the initial trials in Russia has not been disclosed. It's not transparent," said Azar, adding that any COVID-19 vaccine in the US would have to meet its Food and Drug Administration's "gold standard."
The Russian vaccine was issued a certificate of registration despite a trial reportedly involving only 76 people, according to an article in sciencemag.org and other news reports. It's among 165 candidate vaccines listed by the WHO as of July 31, and was still in an early phase of development.
Duterte earlier praised Moscow's offer of COVID-19 vaccines to the Philippines, and said he was willing to be the first to be inoculated in the Philippines.
The Philippines has overtaken Indonesia with the most number of cases in Southeast Asia with close to 140,000 as of Tuesday, despite imposing one of the world's longest pandemic lockdowns.