By Ciara Linnane, MarketWatch
News that Russia has registered the first vaccine to treat COVID-19 before starting and completing Phase 3 trials was greeted with alarm on Tuesday, with experts concerned it may come with safety issues that could stoke antivaccination and anti-science sentiment.
President Vladimir Putin announced the news of the vaccine at a government meeting, The Wall Street Journal reported , following accelerated trials conducted by the Gamaleya Institute for Epidemiology and Microbiology in Moscow in collaboration with the Defense Ministry.
Putin said one of his daughters has already received a dose of the vaccine, which has been named Sputnik-V, referring to the satellite Russia launched into space during the Cold War, beating the U.S. to the punch.
Russia has conducted just two trials of the vaccine, with a third planned after volunteers register. The normal approval process for a new medicine is to gather data from a Phase 1 and Phase 2 trial, and then expand the patient base to thousands in a Phase 3 trial to create enough evidence it is effective and safe.
“There are no Olympic medals for being first,” said Dr. Matthew Schmidt, University of New Haven Associate Professor of National Security and Political Science and a Russia expert, in emailed comments. “Cheating on the scientific process hurts the perception of vaccine safety everywhere. The goal isn’t to be first, it’s to be first in a way that gives people faith in a vaccine’s safety,” he said.
If the Russian vaccine proves to be unsafe, it “could even stoke the antivaccine movement and drive up the number of people who refuse to be inoculated because it will feed conspiracy theories, in the US and elsewhere,” he said.
‘There are no Olympic medals for being first. Cheating on the scientific process hurts the perception of vaccine safety everywhere. The goal isn’t to be first, it’s to be first in a way that gives people faith in a vaccine’s safety.’
Dr. Matthew Schmidt, Associate Professor of National Security and Political Science, University of New Haven
A range of biotechs and drug companies are working all over the world to come up with an effective COVID-19 vaccine, which is for now the only safeguard against the deadly illness that has infected more than 20 million people and killed more than 756,000, according to data aggregated by Johns Hopkins University. The list includes Pfizer Inc. /zigman2/quotes/202877789/composite PFE -0.10% and partner BioNTech SE /zigman2/quotes/214419716/composite BNTX -2.51% , Johnson & Johnson /zigman2/quotes/201724570/composite JNJ +0.21% , Merck & Co. /zigman2/quotes/209956077/composite MRK +1.02% , AstraZeneca PLC /zigman2/quotes/200304487/composite AZN +0.21% /zigman2/quotes/203048482/delayed UK:AZN +0.44% in combination with Oxford University, Moderna Inc. /zigman2/quotes/205619834/composite MRNA +1.27% , Sanofi /zigman2/quotes/206928357/delayed FR:SAN +0.69% and GlaxoSmithKline /zigman2/quotes/209463850/composite GSK +0.72% /zigman2/quotes/200381158/delayed UK:GSK +1.45% , among others.
A vaccine would change the trajectory of the pandemic, allowing economies to fully reopen and people to return to work and school. But vaccine development is normally a lengthy process. Even PhRMA, the pharmaceutical industry’s largest lobbying group, says vaccine development takes 10 years, and the chief executives of Novartis AG /zigman2/quotes/203243705/composite NVS +0.87% and Johnson & Johnson, have said developing a COVID-19 vaccine will take longer than 12 months.
At the same time, several companies developing COVID-19 vaccines have pledged millions and sometimes billions of doses of vaccines that have yet to prove their efficacy.
The World Health Organization has not received enough information on how Russia developed the vaccine to evaluate it, according to Jarbas Barbosa, assistant director of the Pan American Health Organization , a WHO branch, as the Guardian reported.
Barbosa said the vaccine should not be produced until Phase 3 trials have been completed.