Lacking submission to FDA delays review of Sinopharm COVID-19 jab
The application of Southmed Pharma, which seeks to the firm’s distributor in the Philippines, lacked documents such as clinical trial results and certificate of good manufacturing practice, FDA Director General Eric Domingo.
AFP/Noel Celis

Lacking submission to FDA delays review of Sinopharm COVID-19 jab

Gaea Katreena Cabico (Philstar.com) - March 3, 2021 - 3:22pm

MANILA, Philippines — The country’s Food and Drug Administration has yet to evaluate the application of Sinopharm for the emergency use of its COVID-19 vaccine due to incomplete documents.

The application of Southmed Pharma, which seeks to the firm’s distributor in the Philippines, lacked documents such as clinical trial results and certificate of good manufacturing practice, FDA Director General Eric Domingo said. The local company also needs to present proof it is the distributor of Sinopharm in the country. 

“Once they submit the documents, we will begin the evaluation,” Domingo said in a public briefing Wednesday. 

“Until we see scientific evidence, we see the population involved in their Phase 3 clinical trials, their experience in using the vaccine in other countries, that’s the only time we can give recommendation on the use of the vaccine,” he added.

The drug regulator confirmed Tuesday the receipt of an online application seeking emergency use authorization for the jab developed by China’s state-owned pharmaceutical company.

Domingo earlier said it may take “around four to six weeks” before the agency can decide on the application because Sinopharm has yet to receive EUA from a stringent regulatory authority or from the World Health Organization. The lack of relevant documents may delay it further.

“We’re very objective in approving vaccines. We have a checklist of what we’re looking for: safety, efficacy and quality,” he said.

Interim analysis of Phase 3 clinical trials showed that Sinopharm’s COVID-19 vaccine was 79.3% effective in preventing the disease, lower than the reported efficacy rates of Pfizer-BioNTech and Moderna of 95% and 94.1%, respectively. The data, however, have not been peer-reviewed.

So far, only the vaccines of Pfizer-BioNTech, AstraZeneca and Sinovac Biotech have obtained EUAs from the FDA. The application of Russia’s Gamaleya for its COVID-19 vaccine remains pending.

The jab developed by Sinopharm is the one preferred by President Rodrigo Duterte.

It was the same vaccine used by members of the Presidential Security Group, special envoy to China Mon Tulfo, some “Cabinet-level” officials and a senator in an unauthorized vaccine activity last year.

The country began its delayed COVID-19 vaccination campaign Monday, with health workers, government officials and uniformed personnel the first in the line to receive donated Sinovac shots.

As It Happens
LATEST UPDATE: April 19, 2021 - 12:17pm

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 19, 2021 - 12:17pm

The Department of Health approves the resumption of the distribution of AstraZeneca COVID-19 vaccines to persons below 60 years old.

Health Undersecretary Maria Rosario Vergeire says this was upon the recommendation of the country's Food and Drug Administration.

April 16, 2021 - 8:19am

As approved by the inter-agency task force on COVID-19, Priority Group A4 of the National COVID-19 Vaccine Development Plan will include:

  • commuter transport (land, air and sea), including logistics
  • public and private wet and dry market vendors 
  • frontline workers in groceries, supermarkets, delivery services 
  • workers in manufacturing for food, beverage, medical and pharmaceutical products 
  • frontline workers in food retail, including food service delivery
  • frontline workers in private and government financial services 
  • frontline workers in hotels and accommodation establishments 
  • priests, rabbis, imams and other religious leaders 
  • security guards/personnel assigned in offices, agencies and organizations identified in the list of priority industries/sectors
  • frontline workers in private and government news media 
  • customer-facing personnel of telecoms, cable and internet service providers, electricity distribution and water distribution utilities
  • frontline personnel in basic education and higher education institutions and agencies 
  • overseas Filipino workers, including those scheduled for deployment within two months 
  • frontline workers in law/justice, security, and social protection sectors
  • frontline government workers engaged in the operations of government transport system, quarantine inspection worker safety inspection and other COVID-19 response activities 
  • frontline government workers in charge of tax collection, assessment of businesses for incentives, election, national ID, data collection personnel 
  • diplomatic community and Department of Foreign Affairs personnel in consular operations 
  • Department of Public Works and Highways personnel in charge of monitoring government infrastructure
April 15, 2021 - 2:28pm

The US, through the United States Agency for International Development (USAID), will provide P170 million in support to help the Department of Health rollout the government's COVID-19 vaccination program.

According to the US Embassy, the aid was announced by US Embassy Chargé d’Affaires John Law during a visit to a Caloocan City vaccination site with Health Secretary Francisco Duque III and other officials.

"Through this new funding, USAID will support the Philippines in strengthening the vaccine supply chain, monitoring vaccine safety, and delivering effective communication campaigns to address vaccine hesitancy.  This assistance will also support local government units as they plan for, track, and administer vaccines."

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."

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