{"id":265459,"date":"2020-08-16T06:35:29","date_gmt":"2020-08-16T10:35:29","guid":{"rendered":"https:\/\/canadianinquirer.net\/v1\/?p=265459"},"modified":"2020-08-16T06:35:29","modified_gmt":"2020-08-16T10:35:29","slug":"heres-what-we-know-about-russias-unverified-coronavirus-vaccine","status":"publish","type":"post","link":"https:\/\/canadianinquirer.net\/v1\/2020\/08\/16\/heres-what-we-know-about-russias-unverified-coronavirus-vaccine\/","title":{"rendered":"Here\u2019s what we know about Russia\u2019s unverified coronavirus vaccine"},"content":{"rendered":"
\"\"<\/a>
Dubbed Sputnik-V, after the first artificial satellite, the vaccine has been tested in only a small number of people. (Pixabay photo)<\/figcaption><\/figure>\n

Despite incomplete testing, Sputnik-V may be the first COVID-19 vaccine for the general public
\n<\/em><\/p>\n

Russia has launched a new Sputnik \u2014 this time, a vaccine to combat the coronavirus.<\/p>\n

Russian President Vladimir Putin announced in a televised cabinet meeting August 11 that the country is ready to roll out the world\u2019s first COVID-19 vaccine to the general public. Teachers and doctors may be among the first inoculated.<\/p>\n

Dubbed Sputnik-V, after the first artificial satellite, the vaccine has been tested in only a small number of people. The \u00a0announcement came even though no published information is available about the vaccine\u2019s safety and efficacy, and scientists have yet to complete the final phase of clinical testing to determine whether it works. Nonetheless the vaccine has been submitted to the health ministry for registration, comparable to applying for approval from the U.S. Food and Drug Administration.<\/p>\n

It \u201cworks quite effectively. It forms a stable immunity,\u201d\u00a0Putin declared<\/a>.<\/p>\n

Researchers around the world have been\u00a0racing to create a vaccine<\/a>\u00a0(SN: 7\/10\/20<\/em>), but none have been thoroughly vetted yet. Russia has tried various tactics to get in front of the competition, with hackers in the country reportedly trying to\u00a0steal vaccine data<\/a>\u00a0from the United States, Great Britain and Canada. Being the first to approve a vaccine may be a matter of national pride, but the declaration of victory may be premature, some vaccine researchers say.<\/p>\n

Usually, vaccines go through three phases of clinical tests. The first two phases test the vaccine in small numbers of people for safety and may collect data on whether people make antibodies or have other responses to the vaccine. The third phase tests the vaccine in thousands of people to determine whether it lowers the infection rate. That third phase of testing has not even started for the Russian vaccine.<\/p>\n

In an\u00a0open letter<\/a>\u00a0to the minister of health, the Moscow-based Association of Clinical Trial Organizations urged the government to delay approval of the vaccine until after Phase III data is in.<\/p>\n

\u201cWithout that data, it seems reckless to proceed to approving the vaccine,\u201d says virologist Onyema Ogbuagu of the Yale School of Medicine. He is leading Phase III testing at Yale of a vaccine candidate from the drug company Pfizer.<\/p>\n

While information is limited about Russia\u2019s COVID-19 vaccine, here\u2019s what we know so far.<\/p>\n

How does the vaccine work?<\/h4>\n

Researchers at the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, part of the Russian Health Ministry, developed the two-part vaccine. Both parts start with viruses that cause the common cold. Those viruses, adenovirus 5 and adenovirus 26, were each engineered to make the coronavirus\u2019 spike protein. That protein helps the coronavirus latch on to cells and infect them. Since it is on the surface of the virus, it\u2019s also a target for antibodies against the virus.<\/p>\n

This approach is similar to other coronavirus vaccines in the works. The University of Oxford working with AstraZeneca uses a chimpanzee adenovirus. And a vaccine devised by China-based CanSino Biologics Inc. is based on adenovirus 5. Johnson & Johnson uses adenovirus 26 for its vaccine. Those vaccines have gone through\u00a0initial safety tests<\/a>\u00a0where participants made antibodies against the virus and didn\u2019t have any serious side effects (SN: 7\/21\/20<\/em>).<\/p>\n

According to the\u00a0latest trial information<\/a>\u00a0on Sputnik-V, available at clinicaltrials.gov, a U.S. website that tracks clinical trials, 38 people first got a shot containing the engineered adenovirus 26 component. Three weeks later, they received booster injections of the engineered adenovirus 5 component. Results of the study have not yet been published.<\/p>\n

Using two adenoviruses instead of one is unusual, but may help solve a potential problem, says Daniel Kuritzkes, a virologist and infectious diseases doctor at Brigham and Women\u2019s Hospital in Boston. Because the body may develop antibodies to the adenovirus carrying the spike protein, a booster shot with that same virus might be rendered useless. The two-step inoculation with different adenoviruses may sidestep that issue.<\/p>\n

How many people have been tested?<\/h4>\n

It\u2019s unclear. The registered trial tested 38 people. That\u2019s \u201cin the ballpark . . . to make sure it doesn\u2019t kill people, essentially,\u201d Ogbuagu says. \u201cThat\u2019s a good number for a Phase I study, but that\u2019s just the beginning of vaccine development,\u201d he says.<\/p>\n

Russian business people and politicians<\/a>, including one of Putin\u2019s daughters, have also been given access to the vaccine,\u00a0Bloomberg<\/em>\u00a0reports. And the Russian military completed Phase II tests of the vaccine in July, First Deputy Defense Minister Ruslan Tsalikov\u00a0said in an interview<\/a>\u00a0published in the Argumenty i Fakty newspaper.<\/p>\n

Usually, Phase II studies test a vaccine in hundreds of people. But the letter from the clinical trials association says the vaccine has been tested in fewer than 100 people. By contrast, multiple vaccines around the world are now starting Phase III tests with 30,000 people each.<\/p>\n

Why are the larger studies needed?<\/h4>\n

The Phase III tests are what determine whether vaccines actually protect people from infection.<\/p>\n

Testing large numbers of people also allows researchers to uncover rare side effects that might not show up in smaller studies, says Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta. Some side effects may show up in 1 in every 1,000 people. \u201cYou\u2019re unlikely to detect that in a study of 200 people,\u201d he says.<\/p>\n

Even after vaccines are administered to the general public, researchers will be on the lookout for even rarer safety concerns, such as autoimmune diseases triggered by the vaccine, Kuritzkes says. Scientists will also be watching to make sure antibodies made against the vaccine don\u2019t make the disease worse, as has happened with dengue, he says.<\/p>\n

Did the Russians win the vaccine race?<\/h4>\n

\u201cIt\u2019s not a contest, or it shouldn\u2019t be,\u201d says Kawsar Talaat, an infectious diseases doctor at the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health. \u201cThese are not national products. These are international companies that make these vaccines for the world.\u201d The Sputnik-V vaccine probably would not be approved for use in other countries without Phase III trials.<\/p>\n

The best case scenario is that the Russians got lucky and produced a safe and effective vaccine, Talaat says. \u201cThe worst is to have a vaccine that doesn\u2019t work and decimates the public\u2019s trust in vaccines.\u201d And there\u2019s no prize for producing a vaccine that doesn\u2019t work or that isn\u2019t safe, scientists say.<\/p>\n

Most of the vaccines against COVID-19 now in development have demonstrated that they are at least reasonably safe and are triggering production of antibodies and immune cells that may help protect against the virus, Kuritzkes says. The Russian data have not been made public, so it is impossible to tell whether their similar claims are true. But if the data compare with those from other vaccines, Sputnik-V is likely to be safe and efficacious. \u201cOf course, there\u2019s a big difference between predicting it and proving it,\u201d he says.<\/p>\n

Even if one country or company develops a vaccine first, others will be needed, Kuritzkes says. \u201cWe need as many vaccine candidates in development as we can muster. No single company or country can produce enough vaccine to vaccinate the world, and the more success we have, the better off everyone is going to be.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

Despite incomplete testing, Sputnik-V may be the first COVID-19 vaccine for the general public Russia has launched a new Sputnik …<\/p>\n","protected":false},"author":44,"featured_media":265460,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[37],"tags":[],"class_list":["post-265459","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","mauthors-tina-hesman-saey","mauthors-science-news"],"_links":{"self":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/265459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/comments?post=265459"}],"version-history":[{"count":1,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/265459\/revisions"}],"predecessor-version":[{"id":265461,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/265459\/revisions\/265461"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media\/265460"}],"wp:attachment":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media?parent=265459"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/categories?post=265459"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/tags?post=265459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}