The new US plan requires that the majority of non-citizens who wish to enter the country be vaccinated with developments approved by the FDA or by the World Health Organization

The United States announced last week that it will soon open its doors to foreign travelers vaccinated against the coronavirus , easing restrictions on wide swaths of global visitors for the first time since the pandemic began. But the new rules – due to take effect in November – appear to also exclude many people who consider themselves fully immunized, including millions who have received two doses of the Russian Sputnik V vaccine .

Hundreds of thousands of Russians could be directly affected . Despite cold diplomatic relations and limited demand for international travel, roughly 300,000 Russians visited the United States in 2019 , the latest year for which figures are available, according to the American Travel Association .

More generally, the plan of the United States is another blow for manufacturers of Sputnik V , which Moscow has proudly proclaimed as the first vaccine registered for use coronavirus. Although the vaccine was intended to be a powerful tool of pandemic diplomacy, its limited acceptance abroad and slow delivery have left it behind not only Western vaccines, but also those from Chinese manufacturers.

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” This is a huge problem for Russian travelers and for people from other countries who have received Sputnik V, ” said Judyth Twigg , a professor at Virginia Commonwealth University who tracks public health in Russia, about the new US regulations in an email.

The Russian Fund for Direct Investment , the sovereign wealth fund that backed Sputnik V , said in a statement that the vaccine “ has not only been approved in 70 countries where more than 4 billion people live, that is, more than half of the world population, but its efficacy and safety have been confirmed both during clinical trials and throughout its use in the real world in several countries ”.

” We oppose attempts to politicize the global fight against COVID-19 and to discriminate against effective vaccines for short-term political or economic gain ,” the statement continued.

The new US plan requires that most non-citizens who wish to enter the United States be vaccinated with vaccines approved for emergency use by the US Food and Drug Administration or the World Health Organization . This includes vaccines made by Pfizer and Moderna , as well as vaccines developed by Chinese companies such as Sinopharm and Sinovac .

But Sputnik V , an adenovirus vaccine developed by the Moscow- based Gamaleya Research Institute of Epidemiology and Microbiology , has yet to be approved by the WHO . The global health agency stated this week that it has suspended its vaccine review process, citing concerns about manufacturing practices at production plants within Russia and the possibility that the vaccine could be produced consistently with the necessary level.

At a conference in Vladivostok this month, the director of the RDIF , Kirill Dmitriev said that ” mutual recognition of vaccines is the theme of this year” and said that “several companies of the ‘Big Pharma’ intentionally trying, by competitive rivalry, restrain Sputnik and absorb the markets, ”according to the Russian news agency Tass .

Unlike other countries, the United States had no blanket restrictions on travel from Russia prior to this announcement, meaning that all travelers from the country who tested negative for the coronavirus could enter the United States under the guidelines of the Centers for Disease Control and Prevention . This will change in November, when the doors open to millions of travelers from Europe and elsewhere.

The new American rules won’t just affect Russians. According to data from the Global Health Innovation Center at Duke University , some 448 million doses of Sputnik V have been purchased worldwide, many of them destined for low-income countries. Some governments have complained about slow deliveries from Russia . Limited travel options are likely to increase criticism of the Russian drug.

” Russia has squandered an opportunity to use this vaccine as a diplomatic tool ,” Twigg said , citing production problems surrounding Sputnik .

The Russian embassy in Washington declined to comment on the new US policy.

Sputnik V is not the only vaccine that risks being left behind. Neither the FDA nor the WHO have licensed Covaxin from India , of which 560 million doses have been purchased so far, the majority in India. Those vaccinated with Covaxin will not be able to visit the United States in November. There have also been disputes with individual governments that do not accept some vaccines, such as Britain’s refusal to fully recognize the vaccines administered in many parts of the world.

But for Sputnik V , a vaccine that has taken a blatant and sometimes conflicting approach with its rivals, the failure to achieve inclusion in the WHO emergency use list or a similar list by the European Medicines Agency. , an EU body, has been a major blow to its reputation.

Despite the recent suspension of the WHO approval process , the RDIF stated that “ the Russian Ministry of Health is in constant contact with WHO experts on the approval process and we remain confident that the approval of Sputnik V on the part of the world sanitary regulator is imminent due to the excellent record of the vaccine ”.

Some immunization experts have expanded their fears that the extent of US and similar can create two kinds of people vaccinated worldwide: one that can travel freely and one not. In Russia and other countries, travel companies have already started offering their wealthy clients trips abroad, including to places like Serbia , so they can get vaccinated with more accepted vaccines.

Alexander Gabuev , principal investigator at the Carnegie Moscow Center , said there was growing frustration among ” those with money and power ” that their vaccines were not more widely accepted. Some spread ” conspiracy theories , ” said Gabuev , including that ” everyone envies Russia for being the nation that developed the first vaccine ” and that Western powers conspired against Sputnik V .

WHO approval of Chinese vaccines, such as Sinopharm and Sinovac , undermines that message. Although Sputnik V appeared to provide greater protection than these Chinese- backed vaccines , Russia’s role as a vaccine exporter had been severely limited by production problems and China had emerged as a more reliable partner, Gabuev said .

” The approval of the World Health Organization increases the credibility of Chinese vaccines against the Russian ones, ” they added.

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