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Iffy promises

COMMONSENSE - Marichu A. Villanueva (The Philippine Star) - February 10, 2021 - 12:00am

A dispatch from the Russian Embassy in Manila was emailed to me last week about the latest report on the vaccine developed in their country that is expected to help put an end to the continuing spread of the 2019 coronavirus disease (COVID-19) pandemic. It was aptly entitled: “A vaccine for all mankind: Sputnik V’s efficacy in fighting COVID-19 is validated by internationally peer reviewed data published in The Lancet.”

The Gameleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDI) – Russia’s sovereign wealth fund – made a joint announcement of the verdict rendered by “The Lancet.”

The Gameleya is one of the oldest research centers in Russia. The RDIF, on the other hand, is Russia’s sovereign wealth fund established to make equity co-investments, primarily in Russia. The two Russian institutions publicized the interim results of a Phase III clinical trial of Sputnik V as reviewed by “The Lancet” attesting to the vaccine’s high efficacy and safety.

“The Lancet Journal” is recognized like the bible of the global science, medicine and health community. It is among the world’s oldest and best-known general medical journals. It was founded in 1823 by Thomas Wakley, an English surgeon who named it after the surgical instrument called a “lancet.”

In bullets, “The Lancet” cited the following about the interim analysis of Phase III clinical trial of Sputnik V:

• Efficacy of Sputnik V against COVID-19 was reported at 91.6%;

• Analysis included data on 19,866 volunteers, who received both the first and second doses of the Sputnik V vaccine or placebo at the final control point of 78 confirmed COVID-19 cases.

• Efficacy in the elderly group of 2,144 volunteers over 60 years old was 91.8% and did not differ statistically from the 18-60 group.

• Excellent safety profile. Most adverse events (94%) were mild and included flu-like syndromes, injection site reactions, headache and asthenia.

• No serious adverse events associated with vaccination, as confirmed by Independent Data Monitoring Committee.

• No strong allergies, no anaphylactic shock.

The Sputnik V, “The Lancet” cited, stands out among three anti-COVID vaccines that have more than 90% efficacy because of the following “key advantages:”

- Based on a platform of human adenoviral vectors proven to be safe over decades of use.

- Easy distribution worldwide: storage temperature of between two and eight degrees Celsius.

- One of the most affordable vaccines in the world with a price of less than $10 per shot.

According to the same Russian Embassy dispatch, the Sputnik V is already registered in 16 countries: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates (UAE), Iran, Republic of Guinea, Tunisia and Armenia.

In fact, in the first week of this month, vaccination with Sputnik V will start in the following 12 countries: Bolivia, Kazakhstan, Turkmenistan, Palestine, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela and Iran. In 10 countries out of 12, Sputnik V will be the first coronavirus vaccine approved for civil circulation.

Obviously, the Philippines is not in this list. This brings to mind the repeated pronouncements of President Rodrigo Duterte who publicly counts upon his personal friendships with Russian President Vladimir Putin and China’s President Xi Jinping to give priority to the Philippines while the much sought out anti-COVID vaccines were still being developed last year.

National Task Force on the government’s anti-COVID responses, chief implementer Secretary Carlito Galvez Jr. and concurrently the designated “vaccine czar” disclosed Sputnik V remains among the seven anti-COVID vaccines in his procurement list. “Like AstraZeneca, we might open to Tripartite Agreement. Some LGUs (local government units) are already ordering them. On the Government side, we might be open to negotiate for 10-15 million (doses),” Galvez disclosed.

As it turned out, there is nothing definite yet on the supply of Sputnik V for the Philippines.

Galvez signed last month a Tripartite Agreement with the private sector-led initiative to procure the AstraZeneca anti-COVID vaccine that got its emergency authority to use (EAU) from the World Health Organization (WHO) and the Food and Drug Administration of the United Kingdom. This is because anti-COVID vaccine of the AstraZeneca is still under phase 3 clinical trial and therefore can only be secured through EUA on government-to-government negotiations.

Last Jan. 21, Russian Ambassador to Manila Marat Pavlov had video talks with Health Secretary Francisco Duque on the potential use of Russia’s Sputnik V and reportedly told him that the RDIF is ready to start vaccine deliveries as soon as the Philippine FDA grants approval.

Meanwhile, China delivered last Sunday to Cambodia reportedly one million doses of Sinopharm anti-COVID vaccine. Having edge as China’s chief ally in the South East Asia region, Cambodia will now roll out their vaccination starting today for its 10 million people, or 60% of its population despite zero COVID-related death and only 474 recorded cases and 454 recoveries.

As of last check with our FDA, Sinopharm has not applied for EAU nor for clinical trials here. Our FDA has approved China’s other anti-COVID vaccine called Sinovac applied last Jan. 19 to conduct phase 3 clinical trials in the Philippines but it has not started yet since. China’s State Councilor and Foreign Minister Wang Yi who visited the Philippines last Jan. 15-16 officially informed President Duterte about a donation of 500,000 doses of anti-COVID vaccines would be sent to our country.

Both Sinovac and Sputnik V have pending application in our FDA for EAU. And there is nothing definite as to when actually the anti-COVID vaccines will come from Russia and China.

So at this point, the anti-COVID vaccines from President Duterte’s friends from China and Russia are still iffy promises not to come any time sooner.

COVID-19
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