Sputnik V

Russian President Vladimir Putin just approved a COVID-19 vaccine for use in tens of thousands of people, though it has not been thoroughly tested for effectiveness. One of Putin’s daughters had received the inoculation.  “She has taken part in the experiment,” Putin said, according to the Associated Press.

The vaccine was named Sputnik V, in reference to the world’s first artificial satellite, launched during the space race back in the 1960s. Putin said, “We must be grateful to those who made that first step very important for our country and the entire world,” Putin said in a cabinet meeting Tuesday morning, August 11, 2020 in reference to the vaccine developers. There is no published data from early human tests of the vaccine and no late-stage human trials currently underway. Early human tests of the Russian vaccine began in mid-June and included 76 participants, but no data from those trials has been released, according to The Associated Press. 

Scientists worry that there was no phase 3 clinical trial, which is the final stage of testing required for a vaccine to be approved. Phase 3 trials, which include thousands to 30 thousand volunteers, can compare rates of infection between those who are vaccinated and those who get a placebo. In other words, only phase 3 trials can demonstrate that a vaccine prevents COVID-19 infection.

Russia plans to begin such tests of its already approved vaccine on Aug. 12, 2020. Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, told reporters, according to The Associated Press. The phase 3 trial will include “several thousand” participants from the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil, Dmitriev said. But before any data from that trial becomes available, Russia will offer the vaccine to tens of thousands of people, he added. “People outside of clinical trials will have access to the vaccine in August, and some, already on a massive scale, in October,” Dmitriev said.

Without phase 3 data, however, there’s no way to know the vaccine will protect most people who receive it; in addition, rare side effects associated with the vaccine may only emerge as more and more individuals get the injection. Despite not sharing solid proof that its vaccine is both safe and effective, Russia has reportedly received requests from more than 20 countries for access to Sputnik V, Dmitriev said, according to Reuters.

It will be made available first Russia’s front line public-service workers, such as medics and teachers, before being released to the general public, said Russian Health Minister Mikhail Murashko. Medics could have access to it as early as late August or early September, according to the agency.

In testimony to a congressional committee on July 31, 2020, Dr. Anthony Fauci said, “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone. Because claims of having a vaccine ready to distribute before you do testing is, I think, problematic at best.” according to CNN. Fauci added that he remained optimistic that the US would be able to produce its own vaccine by the end of the year, while not cutting corners with safety standards.

Researchers around the world are developing more than 165 vaccines against the coronavirus, and 30 vaccines are in human trials. Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective vaccine by next year. Some trials will fail, and others may end without a clear result. But a few may succeed in stimulating the immune system to produce effective antibodies against the virus.

In he United States, Moderna is developing vaccines based on messenger RNA (mRNA) to produce viral proteins in the body. They have yet to bring one to the market. In partnership with National Institutes of Health, they found that the vaccine protects monkeys from the coronavirus. In March, the company put the first Covid-19 vaccine into human trials, which yielded promising results, After carrying out a Phase 2 study they launched a Phase 3 trial on July 27. The final trial will enroll 30,000 healthy people at about 89 sites around the United States. The government has bankrolled Moderna’s efforts with nearly $1 billion in support. There will be results from the Moderna study in the first quarter of 2021 at the earliest.