International travelers who want to visit the United States will not be allowed entry if they were fully vaccinated with Russia’s domestically developed Wuhan coronavirus (COVID-19) vaccine, Sputnik V.

Earlier in September, the federal government announced that it would change restrictions on foreign visitors first put in place in early 2020 at the beginning of the coronavirus pandemic.

According to the new rules, non-citizens who wish to enter the country must be fully vaccinated with COVID-19 vaccines that have been approved for emergency use by either the Food and Drug Administration or the World Health Organization (WHO).

The three widely used vaccines in the U.S., namely, Pfizer-BioNTech, Moderna and Johnson & Johnson, have been approved. Other vaccines approved include the AstraZeneca vaccine and the Chinese-made Sinovac and Sinopharm vaccines.

The Sputnik V COVID-19 vaccine, developed by the Russian state-sponsored Gamaleya Research Institute, has not been listed as an approved vaccine because it has not been approved for emergency use by the WHO.

The Sputnik V vaccine was the first to be authorized anywhere in the world for use outside of clinical trials. Russian scientists claimed that its efficacy rate is higher than 90 percent against the coronavirus, a claim that has supposedly stood up to peer review. 

Before the changes to the U.S.’s travel rules, Russian visitors did not have specific restrictions placed against them. All potential visitors had to do was to present a recent negative COVID-19 test ahead of their flight.

Refusing to allow travelers vaccinated with the Sputnik V vaccine will prevent millions of travelers from more than 70 different countries from entering the U.S.

The Sputnik V COVID-19 vaccine is not the only vaccine excluded by the U.S. People fully vaccinated with Covaxin, developed in India by Bharat Biotech and the Indian Council of Medical Research, are also barred from entering the country. It has been administered to more than 500 million people in India.

WHO suspends approval process of Sputnik V vaccine

Russian health authorities first applied for approval from the WHO for the Sputnik V vaccine back in February.

One WHO official said the Sputnik V vaccine’s manufacturing process did not meet the WHO’s standards.

“While inspecting one of the plants where the vaccine is manufactured, they found that this plant was not in agreement with the new best practices of manufacturing,” said Pan American Health Organization Assistant Director Jarbas Barbosa. “The producer [of the vaccine] needs to take this into account and make the necessary changes and be ready for a new inspection.”

“The WHO is waiting for the manufacturer to send news that the plant is up to standard,” Barbosa added.

“Any vaccine manufacturer who wants to be approved by WHO has to submit all information about the quality and manufacturing process,” said Barbosa. “They need to prove that sites, where the vaccines are manufactured, are in agreement with best practices.”

The WHO’s previous report regarding one of the Sputnik V manufacturing plants in Russia identified several concerns, including possible cross-contamination, inadequate sterilization of facilities and factory workers not wearing appropriate attire and going through proper sterilization processes.

Other than production concerns, supply issues and political concerns have also slowed Sputnik V’s rollout and hindered its acceptance by the WHO.

While addressing the United Nations General Assembly, Russian Foreign Minister Sergei Lavrov called for the mutual recognition of COVID-19 vaccines.

“COVID-19 is our common enemy,” said Lavrov. “We support mutual recognition of vaccines approved by national oversight bodies, in the interests of lifting restrictions on international travel of citizens as soon as possible.”

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