Covid-19: Mexico close to approving Russian vaccine, with little data

The approval process described by Hugo López-Gatell, Mexico's assistant health secretary, sounded like a Cold War spy thriller, and may not foment confidence in the shot

Mexico said Tuesday it is close to granting approval for Russia's Sputnik V coronavirus vaccine, despite the fact that little public data is available.

The approval process described by Hugo Lopez-Gatell, Mexico's assistant health secretary, sounded like a Cold War spy thriller, and may not foment confidence in the shot.

Lopez-Gatell said a Mexican technical committee on new medications has recommended approving the vaccine, adding only some details were lacking for COFEPRIS, the government medical safety commission, to give the final go-ahead.

The technical part, the main part of COFEPRIS, particularly the committee on new medications, has given a favorable recommendation to authorize, that is to say, the crucial part has been solved, Lopez-Gatell said.

 

But he also said that despite weeks of conversations with Russian officials, he could not get his hands on the results of Phase 3 trials, which are normally published in international medical journals and indicate how effective the vaccine is.

Russian officials have given conflicting accounts, upping the supposed effectiveness of the Sputnik vaccine to higher levels every time a US vaccine reports its results.

Desperate, but with no published data, Mexican President Andres Manuel Lopez Obrador ordered Lopez-Gatell to fly to Argentina, which has already approved and is using Sputnik V, to see what information he could get.

The Argentines gave Lopez-Gatell a closely-guarded copy of Phase 3 trial results and other data on the Sputnik vaccine which he spirited back to Mexico and then submitted the papers to Mexican regulatory officials.

Mexico has been unable to get more than about 750,000 doses of the Pfizer vaccine, about half the amount it needs just to inoculate just front-line health workers. Mexico and had pinned its hopes on China's CanSino vaccine.

But delays in approving that shot drove Lopez Obrador to speak directly to Russian President Vladimir Putin on Monday to try to get the Russian vaccine, the first doses of which are expected to arrive next week.

It is unclear whether the lack of public data might affect Mexicans' willingness to get vaccinated, without knowing how effective or safe the Russian shot is.

I do want vaccines, but ones that have been approved by the World Health Organisation and the international scientific community, wrote Sen. Lilly Tellez of the conservative opposition National Action Party.

The Russian vaccine does not have that yet. It is the cheap vaccine, that is why the government chose it, Tellez wrote in her Twitter account.