Russia, with scant study data, approves coronavirus vaccine.

The Russian health ministry has approved a coronavirus vaccine developed by researchers at a state-backed institute in Moscow, clearing the shot just two months after initial testing in humans began and before large-scale trials prove whether it protects against COVID-19. 

The approval, announced by President Vladimir Putin Tuesday, was granted extraordinarily quickly, even by the standards of an urgent global race to make a coronavirus vaccine available as fast as possible. No other vaccine is authorized nationally, although China has cleared one candidate for military use. 

Results from the two small studies conducted by Moscow's Gamaleya Research Institute are not readily available, although Putin and the Russian health minister said vaccination resulted in high levels of antibodies to the virus. Larger trials involving thousands of people are now being planned, according to the minister. 

Vaccine development has become political, a matter of national pride and scientific prowess as well as a critical component of public health responses to the COVID-19 pandemic. 

Russia's decision to approval Gamaleya's shot on scant data appears the latest, and most significant, sign of what some are terming "vaccine nationalism." A safe and effective vaccine would be a boon for any country, and governments have jockeyed to secure supplies of the most promising candidates ahead of time, leading to dust-ups in France and in Germany. 

As in other countries, Russian leaders have pushed for faster development, raising concerns crucial steps in testing will be bypassed. Similar concerns exist in the U.S., too, where the Trump administration has set a goal of making millions of vaccine doses available by January 2021. 

Typically, the process of proving vaccines safe and effective is a laborious, step-by-step effort that spans many years, if not more than a decade. Facing the deadliest pandemic in a century, scientists across the globe have drastically compressed vaccine design and animal studies, producing a slate of more than 160 experimental candidates.

Twenty-eight of those have progressed into clinical trials, with the most advanced now being studied in large Phase 3 trials that will eventually involve tens of thousands of people.

Gamaleya's vaccine wasn't previously considered in that group of vaccine front-runners, having been tested in only 76 volunteers across two small trials carried out at a state medical university and a military hospital in Moscow.

Such studies are designed to assess safety and test whether vaccination spurs the body to produce an immune response. Proving protection against either coronavirus infection or disease requires evidence from much larger trials that compare a vaccine to a placebo, and track participants long enough for cases to occur.

Tuesday's approval makes Gamaleya's shot the first to be nationally authorized, although that distinction doesn't appear equivalent to approvals in the U.S. or Europe. 

In the U.S., for instance, the Food and Drug Administration has said it would only authorize a vaccine after testing in several thousand people proves protection from coronavirus infection or disease in at least 50% of people. 

Gamaleya's vaccine will be "gradually introduced," Russia's health minister Mikhail Murashko said Tuesday, indicating healthcare workers and teachers could be among the first groups to receive it. Previous reports have suggested a widespread vaccination campaign could begin by October.

Larger trials will be conducted soon, Murashko added.

Russia is already preparing to begin mass production of the shot, which uses two types of a cold-causing adenovirus to deliver genetic material for the coronavirus' "spike" protein. Exposing the body to the protein, scientists believe, will train the immune system to recognize a real infection later. 

CanSino Biologics in China and Johnson & Johnson in the U.S. are taking a similar approach, but each are using a single adenovirus as their delivery vehicle. It's not clear what advantage using two different viral vectors in sequence, as Gamaleya has done, might have, although in theory it could allow for a two-shot regimen without inadvertently triggering the body's defenses.

CanSino and J&J are among the leading companies developing a vaccine. In the U.S., J&J is one of a group of companies working to complete late-stage trials by the fall, with an emergency authorization or approval from the Food and Drug Administration possible late this year or early next. 

Moderna and Pfizer have already begun Phase 3 tests, with AstraZeneca, J&J, Novavax expected to follow in the coming months. 

Several companies in China have also advanced experimental vaccines into late-stage testing, although the pandemic's waning presence in the country have forced developers to seek out partners abroad. The Chinese military approved CanSino's shot for use in members of the military in late June. 

Author:Ned Pagliarulo

Published: https://www.biopharmadive.com/news/russia-coronavirus-vaccine-approval-gamaleya-institute/583308/