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Sputnik V: why hasn't the WHO authorized its emergency use yet?

2021-10-22T23:46:57.555Z


Why has the WHO not authorized the emergency use of the Sputnik V vaccine? Experts from the World Health Organization explain it.


The WHO still does not authorize the Sputnik V vaccine, why?

2:41

(CNN Spanish) - The

United States is about to open its doors to fully vaccinated foreign visitors, although not everyone will be able to enjoy this benefit.

According to US travel policy, a person is only considered fully vaccinated when they have received full doses of vaccines approved or authorized for emergency use by the US and those that are on the list of emergency authorizations from the World Health Organization (WHO).

This leaves out millions of people around the world who have received the Russian vaccine Sputnik V, the Chinese CanSino, or the Cuban vaccines Abdala, Soberana 02, Soberana Plus, conceived as a booster dose for Soberana 02.

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In Mexico alone, the doses of Sputnik V and CanSino vaccines are the fourth and fifth most widely available in the country.

The country has received just over 9 million doses of Sputnik V and CanSino since December 23, 2020, according to data from the Ministry of Health.

But why is the Sputnik V vaccine not included in the WHO emergency use list?

Dr. Mariângela Simão, WHO Deputy Director General for Access to Medicines, Vaccines and Pharmaceutical Products, indicated at a press conference that the process of listing the emergency use of Sputnik V had been stopped until October 20 "due to a legal procedure ", since it was necessary for the applicant to sign that he accepted the rules and procedures of the WHO in order to continue with the evaluation.

  • Russian Sputnik V vaccine expands reach in Latin America

The Sputnik V vaccine evaluation process was resumed on October 21, so inspections of the plants where the drug is produced could be resumed in the coming weeks.

"We will also continue to receive additional data from the Sputnik requester. So this is the process that works for everyone," he added.

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Dr. Simão briefly explained that WHO uses internationally accepted and recognized standards for the process of including vaccines in the emergency use list, the process begins when the manufacturer submits its application and once accepted, it has to send data.

The waiting time for a vaccine to be included in the WHO list "depends on how quickly the manufacturers send the data," said Dr. Simão.

"And in some cases, we need to do factory inspections," he added.

  • What vaccines are valid to enter the US?

Speaking specifically about the Sputnik V vaccine, Dr. Simão indicated that the process called “staggered submission” had already begun, where the applicant uploads technical, clinical data, trials, good manufacturing practices, among others to the WHO site. other necessary data.

However, the manufacturer of Sputnik V had not provided all the necessary documentation.

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WHO responds to the government of Mexico

During the morning conference on October 19, the president of Mexico, Andrés Manuel López Obrador, indicated that he would send a letter to the WHO "respectfully requesting them to accelerate the certification process."

López Obrador said that the WHO had taken "a long time without approving some vaccines."

Two days later, the director general of the WHO, Tedros Adhanom Ghebreyesus was asked about the president's claims, to which he replied: "We have not heard directly from Mexico. If you have any concerns, you can ask us or send a message. This is the first time I receive information that [Mexico] has concerns. "

  • Why can't I enter the US if I got vaccinated with Sputnik V?

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Tedros indicated that if requested, Mexico could send its experts "to see how we do it here. So instead of the president raising these issues, without any contact with experts, it is better to let the experts discuss it. ".

"One thing that I can assure his Excellency the president is that we use data, evidence and principles. Nothing more. And the final recommendation comes from experts with the right skills and experience. That is why we always use evidence and signals," concluded Tedros .

Where to travel if you have Sputnik V?

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Source: cnnespanol

All news articles on 2021-10-22

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