The Philippine Food and Drug Administration has granted an emergency use authorization (EUA) for the Sputnik V coronavirus vaccine developed by Russia’s Gamaleya Research Institute, clearing the way for negotiations to secure millions of doses of the jab for Filipinos.
Russia’s Sputnik V vaccine is the fourth to be granted emergency approval in the Philippines, which has seen a drastic increase in infections over the past few weeks.
In a press briefing on Friday, March 19, Food and Drug Administration Director General Eric Domingo said the vaccine had met conditions to be given an EUA and that a rigorous review of late-stage trial data concluded that known and potential benefits of the vaccine outweighed its known and potential risks.
“The known and potential benefits of the Gamaleya Sputnik V vaccine, when used to prevent COVID-19, outweigh the known and potential risks of said vaccine as of date,” Domingo said.
With the required emergency approval secured, delivery of an initial batch of two million doses of the vaccine may take place as soon as April, according to vaccine czar Carlito Galvez Jr.
The retired general earlier said the government had been waiting on the necessary EUA so that deals to purchase about 10 million doses could move forward.
Why it matters
Emergency approval for Sputnik V offers the government an additional option for vaccine supplies badly needed to complete the inoculation of priority populations, including 1.8 million health workers and 9 million senior citizens.
Currently, the Philippines’ stockpile of vaccines consists of 1.1 million donated emergency doses from Sinovac and AstraZeneca’s vaccine supplied by the World Health Organization’s COVAX global facility.
With infections soaring faster than levels seen during the Philippines’ last deadly surge in cases from July to August 2020, experts have also underscored the urgent need to not only vaccinate all health workers, but scale up vaccinations to cover as many Filipinos as quickly as possible.
Aside from the government’s procurement, a tripartite agreement is also being considered to open up access to more doses of Gamaleya’s Sputnik V vaccine.
But similar to all other vaccines that had been granted emergency approval so far, the FDA stresses that the EUA is not equivalent to full approval necessary to commercialize the vaccine. Securing full marketing authority would be contingent on the company’s commitment to finish development of the product.
How Sputnik V performs
Peer-reviewed analysis of trial data showed that Russia’s Sputnik V vaccine is safe, demonstrated nearly 92% efficacy against symptomatic cases of COVID-19, and provided complete protection against moderate to severe cases.
Russian scientists have also said that a trial in Russia testing the effectiveness of revaccination with the Sputnik V shot to protect against new mutations of the coronavirus was producing “strong results.” Results of the trial are expected to be published soon.
Since the last peak in cases observed in 2020, the Philippines has reported the presence of more infectious variants first found in the United Kingdom, South Africa, and Brazil. On March 13, the Philippines also reported detecting a variant of the virus that contained mutations found in other variants of concern, though health officials said the variant was still considered to be under investigation.
Peer-reviewed results published in the Lancet buffed the image of the Sputnik V vaccine after Russian President Vladimir Putin’s announced in August 2020 that the shot had been approved – despite very limited data available at the time. Putin’s announcement had been met with international skepticism and concern as there had been no evidence yet from large-scale clinal trials.
The Sputnik V vaccine would be relatively less tedious to deploy in the Philippines as it can be stored in standard 2 to 8 degree Celsius (36 to 46 degrees Fahrenheit) refrigerator temperatures and does not require ultra cold storage conditions.
Read Rappler’s series of explainers on the Duterte government’s vaccine program below:
- TIMELINE: The Philippines’ 2021 COVID-19 vaccine plan
- EXPLAINER: What to expect once COVID-19 vaccines arrive in the Philippines
- EXPLAINER: How COVID-19 vaccines will get from warehouses to you
- Securing vaccine deals: A checklist for local governments
- TRACKER: Which COVID-19 vaccines are being eyed by the Philippines?
- How FDA grants emergency approval for COVID-19 vaccines, meds
- PH to prioritize high-risk areas, sectors for COVID-19 vaccine rollout
- Gov’t releases new vaccine priority list, includes persons with comorbidities
- MAP: Which countries have started their COVID-19 vaccination program?
- LIST: Local governments’ plans, deals, and budget for COVID-19 vaccines
- Philippines targets purchase of 148 million doses of COVID-19 vaccine in 2021