Russia stunned the world in August 2020. When most vaccine candidates being developed in the United States, the United Kingdom, China, and Germany were still in the clinical trial phases, Moscow announced the emergency approval of Sputnik V, your first immunization against COVID-19.
Criticism rained down on Vladimir Putin’s government for the accelerated approval of the vaccine, weeks before the start of massive clinical trials to verify the safety and efficacy of the vaccine. However, since Phase 1/2 of the trials, Sputnik had shown encouraging results.
Doubts about the vaccine – developed by the Gamaleya Institute in Moscow – have not ceased despite the publication of Phase 3 results in the prestigious medical journal The Lancet, nor because it has already been approved by more than 60 countries. including Mexico.
The World Health Organization (WHO) and the European Medicines Agency (EMA) are still evaluating whether they will grant their emergency approval for this vaccine. Italian Prime Minister Mario Draghi has not hesitated to express his doubts about Sputnik V.
“The Sputnik vaccine (…) has not yet managed to obtain and may never obtain the approval of the EMA,” said the Italian premier on Friday, June 25, at the end of a summit of European Union leaders.
Even many Russian citizens distrust the vaccines produced in their country, which may explain the failure of its immunization campaign by the Russian government, which admitted that it will not reach the goal of vaccinating 60% of its population during the autumn.
This we know about the Sputnik V vaccine, which is named in honor of the launch of Sputnik-1, the first artificial satellite in history and which marked a milestone in the space race with the United States.
How many doses are of the Sputnik vaccine?
Sputnik V is a vaccine based on a proven adenoviral vector platform, according to the official vaccine site. Currently, Russia distributes in the world and in its own territory a two-dose scheme, priced at $ 10 per injection.
The vaccine is indicated in people over 18 years of age, including older adults. The vaccination scheme is two doses of 0.5 ml each, applied intramuscularly in the deltoid muscle of the arm of less use, with an interval between them of 21 days after the first dose is applied, according to the Secretary of Health of Mexico.
People who start the vaccination schedule with the Sputnik V vaccine must complete the schedule with the same product, as there is still information on interchangeability with other available vaccines against COVID-19, according to the Mexican authorities.
On May 6, the Russian Direct Investment Fund (RDIF) – which finances the development of this vaccine – announced the launch of Sputnik Light, a single-dose version of Sputnik V, which could be aimed primarily at export.
“Sputnik Light does not require special storage and transport conditions and has an affordable price of less than $ 10,” according to a statement from the FIDR.
What are the adverse effects and reactions of Sputnik V?
The most common adverse effects of the Russian vaccine with the following:
● Pain, hyperemia (localized increased blood supply) and swelling at the injection site
● Headache
● Chills
● Fever
● Muscle pain
● Joint pain
● General fatigue
In case of pain at the injection site, the application of moist compresses (neither cold, nor warm, nor hot) is recommended, and neither is the consumption of analgesics of the salicylate type (such as aspirin), since side effects can be erroneously related to vaccination, according to the Technical Guide for the application of the Sputnik V vaccine of the government of Mexico.
Other less common side effects of the Sputnik V vaccine include the following:
● Nausea
● Indigestion
● Decreased appetite
● Unusual and regional enlargement of the lymph nodes
Most of these side effects are mostly mild or moderate and can develop within the first day or two after vaccination, and resolve within three days, according to the Argentine government’s Vaccine Manual.
Some patients may develop allergic reactions. The Ministry of Health of Mexico recommends that, in case of presenting a serious allergy after 30 minutes of observation in the vaccination module, the vaccinated person should receive immediate medical attention at the nearest hospital.
What is the efficacy of the Sputnik vaccine against COVID-19 and its variants?
In February 2020, the prestigious medical journal The Lancet considered that the Sputnik V vaccine was 91.6% effective against the original strain of COVID-19, dispelling doubts about its reliability.
The increase in cases in Russia, mainly in Moscow, in recent weeks has been related to the Delta variant of COVID-19, originally detected in India and which is much more contagious. This has cast doubt on the efficacy of this immunizer against this strain of SARS CoV-2.
The effectiveness of the Russian anticovid Sputnik V vaccine is 2.6 times lower against the Indian variant of the coronavirus, Denis Logunov, the deputy director of Research at the Gamaleya Center, developer of the preparation, said on Tuesday.
Sputnik V has shown an efficacy of 97.6% in the vaccination campaign of the Russians, but the Indian variant, mainly the Delta “slightly lowers the activity of the serum,” Logunov said at a press conference.
However, he maintained that, according to foreign magazines, in the case of Pfizer and Moderna vaccines the effectiveness is 3 to 5 times lower against the Indian variant.
The Gamaleya Institute assures that, even so, the effectiveness of its vaccine against the Delta variant of COVID-19 is almost 90%.
On its power to prevent a serious infection or death from the disease, a study by the Ministry of Health was published in Argentina on Friday indicating that a single dose of the Sputnik V or AstraZeneca vaccines reduces mortality from COVID-19 by 70 and 80% in people 60 years and older.
About the efficacy of Sputnik Light, the single-dose version of this vaccine, it was announced in its presentation that it had an efficacy of 79.4%. This same vaccine showed an efficacy of 78.6% to 83.7% among the elderly in Argentina, according to data from the Ministry of Health of the province of Buenos Aires published on June 2.
How has the passage of the Sputnik vaccine been in Mexico?
When the arrival of the first doses of the Sputnik vaccine in Mexico was announced, the negative comments on social networks about this formula were so strong that
“We have collected the most common arguments from critics of Sputnik V,” wrote the Embassy on its social networks, where it answered the questions.
Regarding the results of the clinical trials, the Russian Embassy recalled that those of phases 1 and 2 were published in the prestigious international journal The Lancet , and announced that those of phase 3 are close to being published.
It also indicated that the statement “has not been proven to work in practice” is false, since in a phase 3, double-blind, randomized, placebo-controlled, post-marketing clinical study of the Sputnik V vaccine, 40,000 volunteers participated, proving their effectiveness.
Laboratorios de Biológicos y Reactivos de México (Birmex) announced on the 7th that from the end of June it would begin the process to package the Russian Sputnik V vaccine in Mexico.
The laboratory, which belongs to the federal government, added that it submitted to the Federal Commission for the Protection against Sanitary Risks (Cofepris) the file of Sputnik Light, the Russian single-dose vaccine, for review and authorization of emergency use in Mexico. .
The local production of Sputnik V took place during a visit by the Mexican Foreign Minister, Marcelo Ebrard, to Moscow in late April and in response to delays in the shipment of doses from different pharmaceutical companies, including Sputnik V itself, and the packaging of the AstraZeneca vaccine in Mexico.
Mexico reached an agreement with the Russian government – after a call between Presidents Andrés Manuel López Obrador and Vladimir Putin – to acquire 24 million of these biologicals.
With information from AFP, EFE and Reuters
