• Russian President Vladimir Putin announced that Russia has developed a coronavirus vaccine, and officials in the country anticipate that tens of thousands of people will receive it in the next few months.
• Russia is planning a mass rollout of the vaccine in October, with teachers and healthcare workers having the ability to volunteer to get it even sooner.
• However, health officials are concerned that Russia rushed through the vaccine process, as the vaccine has not been through Phase 3 trials. That months-long process involves testing thousands of individuals and is considered essential in developing a vaccine.
• Others have also expressed skepticism over the vaccine as Russia has yet to release data from its initial clinical trials.

Russia Announces Vaccine

President Vladimir Putin announced Tuesday that Russia has developed a coronavirus vaccine, prompting concerns from health officials who believe the country’s process in doing so was rushed and lacked crucial tests. 

“A vaccine against coronavirus has been registered for the first time in the world this morning,” Putin said while delivering the Tuesday announcement. “I know that it works quite effectively, it forms a stable immunity.”

The vaccine, which has been dubbed “Sputnik V,” was developed by The Gamaleya Institute and was funded by the Russian Direct Investment Fund. Officials say there could be a mass rollout for it in October, but prioritized individuals like teachers and healthcare workers could volunteer to get it sooner. Tens of thousands are expected to receive the vaccine in the next few months. One of his daughters has already received it.

“Of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin added in his address. 

As the Associated Press explained, this vaccine uses a different virus, the common cold-causing adenovirus, and modifies it to carry genes for the “spike” protein that coats the coronavirus. Scientists in China and the U.K. are working on a similar vaccine.

However, Russia approved the vaccine before it ever went through Phase 3 trials, which is a crucial step that involves administering the vaccine to thousands of people. Phase 3 trials could last for months, and while Russia said they will be conducting them and doing trials in countries like the UAE, Saudi Arabia, the Philippines, and maybe Brazil, the vaccine will still be offered to volunteers who want it in the meantime. 

Health Officials Express Concern

Health experts fear that distributing the vaccine before Phase 3 results are in could be dangerous. They fear Russia was racing to be the first country to offer up a vaccine, as Putin has previously said he wanted one by September. 

According to the AP, human trials started back in June with 76 volunteers, half of which were injected with a liquid vaccine and the other half given on in the form as a soluble powder. Some of those volunteers were recruited from the military, prompting concerns that they may not have been volunteers at all, and were actually pressured into participating. 

“Normally you need a large number of people to be tested before you approve a vaccine. I think it’s reckless to do that if lots of people haven’t already been tested,” Peter Kremsner, an expert at Germany’s University Hospital in Tuebingen told Reuters.

Kremsner was not alone, other health officials told Reuters that releasing a vaccine at this stage is “unethical” and could lead to the pandemic only being worsened. On top of this lack of testing, Russia has also not released any data from its initial clinical trials. 

“It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis,” Keith Neal, a specialist in the epidemiology of infectious diseases at Britain’s Nottingham University said in a statement. 

Vaccine Response from U.S. Leaders

Even before Russia touted its new vaccine, there were concerns about how the country was developing it. While testifying to Congress in July, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said he was worried about a lack of testing. 

“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone,” he said. “Because claims of having a vaccine ready to distribute before you do testing is, I think, problematic at best.” 

Since Russia’s announcement, other U.S. officials have also expressed their fears. Secretary of Health and Human Services, Alex Azar criticized the pace at which it was produced while speaking with Good Morning America on Tuesday. 

“The point is not to be first with a vaccine, the point is to have a vaccine that is safe and effective for the American people and the people of the world,” he said. “We need transparent data, and it’s gotta be Phase 3 data.” 

Azar’s remarks line up with statements recently made by Food and Drug Administration Commissioner Stephen Hahn.

“Let me assure you that we will not cut corners,” Hahn said while speaking to the American Medical Association on Monday. “All of our decisions will continue to be based on good science and the same careful deliberative processes we have always used when reviewing medical products.”

Vaccine Hesitancy in the United States

Releasing a vaccine too early could lead to a number of consequences. Say the process was rushed and the vaccine is ineffective or dangerous, it could lead to people being too nervous to get one when it is actually safe to do so. Reservations about a coronavirus vaccine are widespread, and go further than just the usual anti-vaxx crowd. 

Polling on the subject shows scattered numbers, but most indicate that many are uninterested or paranoid when it comes to a COVID-19 vaccine. An August Gallup poll found that if a free FDA approved vaccine were ready today, one in three Americans would still refuse it. Polling from Yahoo and YouGov shows that back in May, 55% of U.S. adults planned on getting vaccinated, but by the end of July, that fell to 42%.

See what others are saying: (Washington Post) (Wall Street Journal) (Business Insider)