Sinovac cleared for test trials

FDA okays two other drug firms, full rollout hinges on pilot run results

The Food and Drug Administration (FDA) has approved the application of Chinese drug manufacturer Sinovac to conduct clinical trials of its COVID-19 vaccine in the Philippines.

In a press briefing Tuesday, FDA director general Eric Domingo said all of the companies that applied for clinical trials, including Sinovac, have been approved.

These include Janssen of Johnson & Johnson, a US firm, and Clover Biopharmaceuticals, another Chinese company.

In October 2020, the Department of Science and Technology’s Vaccine Expert Panel cleared Sinovac for clinical trials, elevating the process to the Ethics Board and the FDA.

At the same briefing, Domingo said China’s donation of 500,000 doses of a COVID-19 vaccine would not affect the FDA’s assessment of vaccine candidates from Chinese drug companies.

The FDA is evaluating the applications of pharmaceutical firms for clinical trial and emergency use authority (EUA) for their respective COVID-19 vaccine products.

During a visit to Manila over the weekend, Chinese Foreign Minister Wang Yi said Beijing intends to donate half a million doses of a COVID-19 vaccine to the Philippines.

Senator Francis Pangilinan said while he appreciated the gesture, the donation should not pressure the FDA and the Health Technology Assessment Council to approve the use of Chinese vaccines.

"Science and the data and results of clinical trials should be the sole basis and not 'political goodwill'," he said.

Asked if his agency is being pressured due to the large donation of vaccines by China, Domingo said, “No, because the donation and the EUA are not related.”

Domingo said companies can donate vaccines approved for use by another country, and these can be accepted by the Department of Health upon the FDA’s approval.

However, for vaccines procured by the government, an EUA is required, and they can only be released once the whole process is completed.

Under the Bayanihan Act, the government can accept donations of drugs, he said.

“Of course, it should be used under the supervision of the Department of Health,” he said. “But it’ll be their decision if they will receive and use it.”

Domingo said Sinovac has promised to submit all its requirements—including the interim results of its Phase III trials and a copy of the EUA that China had granted it — for its local EUA application.

On Monday, Palace spokesman Harry Roque contradicted the government’s own vaccine czar, Carlito Galvez Jr., who said the decision to buy 25 million doses of Sinovac’s vaccine was “not a done deal.”

Roque said the Philippines already had a binding agreement to buy the Chinese vaccines.

Domingo said if the first shipment of Sinovac vaccines arrive before it is issued an EUA, they cannot be used.

“Their EUA really depends on how fast they can relay their data,” Domingo said in Filipino.

So far, only Pfizer has received an EUA from the Philippines. The American company submitted their documents before Christmas and got the approval three weeks later.

While Pfizer has already been listed for emergency use by the World Health Organization and has received approval from the United States and the United Kingdom, Sinovac has yet to receive an EUA from a so-called mature regulatory authority.

Domingo also said any EUA may be revised or revoked if a vaccine is later found to have adverse effects.

His remark was in response to a question about Norway’s report that 33 elderly people who were given the Pfizer COVID-19 vaccine later died.

Norway’s Institute of Public Health and other experts have said it is important to note that the patients were of advanced age and had serious illnesses and that the mortality rate in this group was high.

“At any time, an EUA can be revoked. This is not a registration. Anytime we get new data such as the one about allergies or the elderly, we can always incorporate it in the EUA and revise conditions for use,” Domingo said.

The Pfizer EUA already has a warning against its use by those with severe allergies to vaccines.

Domingo said an advisory on the elderly may be added if it is proven that the vaccine was linked to the deaths in Norway.

“What will happen is that we’ll be very careful with the very elderly, especially those more than 85 or 90 years old and very frail and those with many illnesses,” he said.

Domingo said they are coordinating with Pfizer so they can update the protocol once they learn more about what happened in Norway.

Also on Tuesday, the Palace said the country will secure at least 20 million doses of COVID-19 vaccines from Moderna Inc.

Roque said the vaccine procurement from Moderna will boost the country’s supply deals to purchase 72 million doses from Novavax, Sinovac, and AstraZeneca.

The government has so far secured 30 million vaccine doses developed by Novovax and the Serum Institute of India, 25 million doses from China’s Sinovac, and 17 million from the UK-based AstraZeneca.

In other developments:

• Testing czar Vince Dison of the National Task Force on COVID-19 said the government is negotiating with private companies for cold chain facilities for storing COVID-19 vaccines that need to be kept in ultra-low temperatures.

• Senate President Pro Tempore Ralph Recto welcomed the proposal to set up an indemnification fund for Filipinos who may be harmed by COVID-19 vaccines, but stressed that “the focus should be on strengthening emergency response to the very, very few who may suffer side effects.”

“Insurance is good. But immediate medical intervention is better,” Recto said.

• Senate President Vicente Sotto III said President Rodrigo Duterte was being fed the wrong information about the senators’ choice of vaccine, saying they did not favor any particular brand or manufacturer. Duterte on Monday night taunted senators for favoring Pfizer, saying that people have died after taking it in Norway, and that he would order enough doses for the senators, if that is what they wanted.

• Senator Christopher Go asked Filipinos to trust the national government when it comes to the procurement and subsequent rollout of sufficient, safe, and effective vaccines against COVID-19 across the country. He also renewed his earlier request to Galvez to further explain to the public the national vaccine roadmap to overcome public reluctance and build vaccine confidence.

Topics: Food and Drug Administration , COVID-19 , Vaccine , Francis Pangilinan , Sinovac , China
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