Mexico said Tuesday it is close to granting approval for Russia’s Sputnik V coronavirus vaccine, with lots of spy drama but little public data available.
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.
López-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,” López-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 U.S. vaccine reports its results.
Desperate, but with no published data, Mexican President Andrés Manuel López Obrador ordered López-Gatell to fly to Argentina, which has already approved and is using Sputnik V, to see what information he could get.
The Argentines had to call the Russians to get permission to share the closely-guarded files with the Mexicans.
Within a day or two, the Argentines gave López-Gatell a copy of Phase 3 trial results and other data on the Sputnik vaccine which he spirited back to Mexico, and then submitted to Mexican regulatory officials.
But the plot got thicker, because even though the technical committee has given a favorable recommendation, it turns out the application hasn’t even been formally filed yet. Mexican authorities apparently can’t grant authorization based on what may be a sheaf of photocopies from who-knows-where obtained through back channels.
López-Gatell said Mexico is currently trying to get the Russians — who don’t appear to have much experience dealing with regulatory agencies — to designate a person to formally submit what appears to be an already-approved application.
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 López 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 Organization and the international scientific community,” wrote Sen. Lilly Téllez 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,” Téllez wrote in her Twitter account.
Source: Associated Press – MARK STEVENSON