What must happen for the United States to allow entry of people vaccinated with Sputnik



[ad_1]

However, being vaccinated is not enough, as it is mandatory to have applied one of the doses currently approved by the World Health Organization. This excludes the Sputnik V vaccine, produced by the Gamalea Institute from Russia.

The United States currently considers approved vaccines that have been analyzed by the FDA (local regulator) or WHO, as in the case of AstraZeneca.

For travelers vaccinated with Spuntik V to enter the United States, he must have the approval of one of the two organizations mentioned. At first glance, the most plausible option for the drug developed by Gamaleya in the last few hours seemed to come from the WHO, but that ultimately various obstacles slowed down the process.

What should change for Argentines vaccinated with Spuntik V

The WHO was willing to pre-approve the drug, but reported a few days ago that it had discovered multiple violations at a Pharmstandard factory in the Russian city of Ufa. At a press conference by the Pan American Health Organization (PAHO), a regional arm of the WHO, Deputy Director Jarbas Barbosa confirmed the suspension.

“Russia’s emergency clearance offer has been suspended after several manufacturing violations were discovered during a WHO inspection in Russia in May.”He said, adding that Sputnik V’s Emergency Use List (EUL) process had been put on hold because the plant in question did not comply with best manufacturing practices.

At the same time, he explained that he had already addressed his concerns and that inspectors had not questioned the safety or effectiveness of the vaccine. However, independent scientists and industry figures told The Moscow Times that manufacturing defects could compromise the quality of the vaccine.

The way out of this mess could come from the hand of further inspections. This was suggested by the WHO itself on Wednesday, noting that it was still awaiting an update from Pharmaceutical standard.

If the changes required by the healthcare organization are made, the path to emergency approval could be paved again in the short term. However, for the moment neither the WHO nor Moscow have announced new inspections to certify the quality of the vaccine.

Once WHO is approved, the fate of the vaccine should follow the same path that is currently unfolding with the one developed by Oxford-AstraZeneca. The drug developed by the British university and the Anglo-Swedish laboratory It does not have US FDA approval, but it is WHO approved, allowing travelers who have received these doses to enter the United States.

So far, the inoculants approved by the WHO are those developed by Pfizer-Bionetch, AstraZeneca, Johnson & Johnson-Janssen, Moderna, Sinopharm and Sinovac.

[ad_2]
Source link