Palace says Sinopharm files EUA for COVID-19 jab but FDA has no info yet

Gaea Katreena Cabico (Philstar.com) - March 1, 2021 - 12:55pm

MANILA, Philippines (Updated 1:31 p.m.) — The country’s Food and Drug Administration said it has yet to receive an application from China’s Sinopharm for the emergency use authorization of its COVID-19 vaccine, contrary to the pronouncement of Malacañang that it has already sought for an approval. 

In a briefing Monday, presidential spokesperson Harry Roque said the Chinese state-owned company has submitted an application for the emergency use of its COVID-19 vaccine. 

“They have already filed with the FDA an application for EUA for Sinopharm vaccine,” Roque said. 

FDA: No info as of Friday

But FDA Director General Eric Domingo said he has not seen any application from Sinopharm as of Friday. 

“I have not seen one as of Friday. I’m not sure if they filed online… FDA is closed [today] because it’s Araw ng Muntinlupa holiday here in Alabang,” Domingo told Philstar.com.

“As far as I know, we have yet to evaluate EUA application from Sinopharm,” he also said in Filipino during a Laging Handa briefing. 

The FDA chief noted that in case the firm applies for EUA, it may take more than 21 days before the agency can decide on its application. 

“Maybe a month, around four to six weeks because Sinopharm has yet to receive EUA from a stringent regulatory authority or from WHO,” he said.

Last December, Sinopharm said its vaccine was 79.3% effective in preventing COVID-19, lower than the reported efficacy rates of Pfizer-BioNTech and Moderna of 95% and 94.1%, respectively.

Duterte’s choice

The jab developed by Sinopharm is the vaccine preferred by President Rodrigo Duterte. The 75-year-old chief executive cannot receive Sinovac’s CoronaVac—the only vaccine available in the country at the moment—since his age falls outside the range of 18 to 59 suitable to get the shot. 

The Sinopharm vaccine was the one used by the Presidential Security Group in an unauthorized inoculation activity last year despite lacking regulatory approval. 

Special envoy to China Mon Tulfo also revealed last month the he received smuggled Sinopharm shots along with some “Cabinet-level” officials and a senator. He said a friend had smuggled the vaccines into the country. 

The FDA and the National Bureau of Investigation launched separate investigations into the unauthorized inoculations. 

In February, the FDA issued a “compassionate use license” for Duterte’s security detail to take 10,000 Sinopharm jabs. 

The country finally kicked off its COVID-19 vaccination campaign Monday, with health workers and government officials among the first in the line to receive Sinovac shots. 

As It Happens
LATEST UPDATE: April 13, 2021 - 8:42pm

The national government has so far secured two official deals for COVID-19 vaccine supplies in the Philippines, one with Chinese pharmaceutical company Sinovac and another with the Serum Institute of India.

Watch this space for bite-sized developments on the vaccines in the Philippines. (Main image by Markus Spiske via Unsplash)

April 13, 2021 - 8:42pm

Top US health authorities recommended a "pause" in the use of the Johnson & Johnson Covid-19 vaccine "out of an abundance of caution" as they investigate any links between it and blood clots, a regulator said Tuesday.

The US Food and Drug Administration and the Centers for Disease Control are assessing the "potential significance" of six reported cases of a rare blood clot in patients who have received the shot, the FDA tweeted. 

"Until that process is complete, we are recommending this pause," it said.

The regulator said that as of Monday more than 6.8 million doses of the J&J vaccine had been administered in the US.

"CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare," the FDA stated on Twitter. — AFP 

April 13, 2021 - 11:20am

Some 20 million doses of Russian-made Sputnik V COVID-19 vaccine are expected to arrive in the Philippines within the next four months.

Vaccine czar Carlito Galvez Jr. says the government will sign a supply agreement with Russia's Gamaleya Research Institute this week.

“It can be used on the elderly, so from 18 and above. So we can use this and the good thing is at least in the absence of AstraZeneca, we can use this,” Galvez says in an interview with ANC's "Headstart."

April 8, 2021 - 11:35am

Valenzuela City Mayor Rex Gatchalian gets his first dose of COVID-19 vaccine.

A post on Valenzuela City's official Twitter account says the mayor chose Chinese-made Sinovac.

April 7, 2021 - 9:23pm

Germany's Bavaria region has signed a provisional agreement to buy doses of Russia's Sputnik V coronavirus vaccine once it is approved by European regulators, state premier Markus Soeder said Wednesday.

The southern state has "signed a memorandum of understanding today... for the supply of Sputnik," Soeder told reporters in Munich. 

If the Sputnik vaccine is approved by the European Medicines Agency (EMA), Bavaria is set to receive around 2.5 million doses in the coming months through a company in the Bavarian town of Illertissen, Soeder said. — AFP

April 5, 2021 - 12:59pm

At least 795,320 Filipinos have been vaccinated with their first dose vaccine against COVID-19 as of April 3.

Data from the National Task Force against COVID-19 shows that 765,871 of those who were already vaccinated are frontline healthcare workers, 16,121 are senior citizens and 13,288 are individuals with comorbidity.

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