Despite its high effectiveness, the WHO has not yet given its approval.
Foto:
KIRILL KUDRYAVTSEV / AFP / Getty Images
This Friday, the government of the The United States officially announced the opening of its borders, both terrestrial and areas, to any foreigner who wants to make a non-essential trip (for tourism or for family visits), as long as they are already fully vaccinated against the coronavirus.
The measure is not good news for millions of foreigners, particularly Mexicans and Latin Americans, since Only those vaccinated with vaccines approved by this country and by the World Health Organization (WHO) will be able to enter the United States.
In some countries such as Mexico, several of these vaccines have practically been applied, but also millions of inhabitants of this nation and other Latin Americans have received a complete picture of other vaccines that have not yet received approval from the WHO. and its emergency use has not been approved either.
One of them is the Russian Sputnik V vaccine, which despite having shown more than 90% effectiveness, for multiple reasons has not yet been endorsed by international health authorities.
Reasons why the Russian Sputnik vaccine has not yet been approved
One of the main reasons why WHO has not included this vaccine on its approved list is that problems have been detected in your manufacturing plant, located in the Russian city of Ufa, since according to the Pan American Health Organization (PAHO), does not meet the highest production standards.
“The process for the emergency use list (EUL) of Sputnik V was suspended because while they were inspecting one of the plants where the vaccine was manufactured, they found that the plant was not in accordance with the best manufacturing practices,” said Jarbas Barbosa , deputy director of PAHO.
Some WHO representatives visited the Pharmstandard factory some time ago, indicating that they observed “Problems with the implementation of adequate measures to mitigate the risks of cross contamination.”
After this, according to WHO standards; which must “demonstrate that the sites where the vaccines are manufactured are in accordance with best practices”, Sputnik V was still under review and the health agency would carry out a new inspection to finally certify the Russian serum.
In this context, the pharmaceutical company indicated in a statement published in June that the controversy had been resolved while emphasizing that the WHO never questioned the effectiveness or safety of the vaccine.
According to Pharmstandard, the WHO “did not identify any critical problem”, which is why the laboratory invited the agency to carry out a new inspection: “We continue to be completely transparent and we will continue with the WHO prequalification process”, they assured at the time .
However, the WHO suspended the approval process that Russia requested to begin in February 2021, the month that Vladimir Putin’s nation also extended the request to the European Medicines Agency (EMA), a body that it has also not approved the vaccine.
Now, according to the agency, is that they do not have complete information on the production process of Sputnik V.
According to Barbosa, “any vaccine manufacturer that wishes to be approved by the WHO must present all the information on the quality and the manufacturing process”, so the manufacturers of the Russian serum developed by the Gamaleya Institute must “demonstrate that the sites where vaccines are manufactured according to best practices ”.
“The producer must take this into account, make the necessary changes and be ready for new inspections. The WHO is waiting for the manufacturer to send the news that their plant complies with the code, “he added.
It may interest you:
* Merck pill against covid-19: how much will they cost and when will they be available? All you need to know
* The United States already required vaccination against eight diseases before COVID-19
* COVID: Pfizer Vaccine Effectiveness Decreases Over Months; still protects against death and hospitalization in 90%
eldiariony.com
Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.