COVID-19 vaccines: Where is PH in the procurement, clinical trials?

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Metro Manila (CNN Philippines) — This year, the government targets to vaccinate millions of Filipinos against the dreaded coronavirus, which has claimed thousands of lives and pushed the economy into recession.

Authorities are in talks with around seven vaccine makers to secure 148 million doses, enough to inoculate up to 70 million people.

Members of the Presidential Security Group got COVID-19 vaccine shots as early as September 2020, but investigations are underway into how these unauthorized vaccines presumably were “smuggled” into the country and used on President Rodrigo Duterte’s detail.

Officially, no vaccine has been delivered yet to the country, but vaccine czar Carlito Galvez Jr. says the first batch may arrive by February. The World Health Organization said in a January 6 media briefing, the country is “on track” in preparing for the rollout.

There are two ways vaccines could reach Filipinos. One is through procurement, which is being handled exclusively by the national government, although tripartite agreements can be entered into by the private sector and local government officials.

The other is through phase 3 clinical trials, a crucial stage where thousands of people are injected with the vaccine to test for safety and efficacy. In normal situations, these phase 3 tests determine whether a vaccine can be approved by governments for use on their people.

Here’s a rundown of where the Philippines now stands on the road to vaccination.

What’s been secured?

As of the second week of January, officials have announced securing 72 million doses of COVID-19 vaccines but later clarified that those from China’s Sinovac are not yet a “done deal.”

What’s clear for now is that the country has purchased in advance 17 million doses from UK’s AstraZeneca through tripartite agreements involving over 300 private companies and 39 local government units.

The Philippines also inked a term sheet for 30 million doses of Covovax vaccine through negotiations with the manufacturer Serum Institute of India, which did not ask for advance payment, officials said. The vaccine was developed by Novavax of the United States.

The other 25 million doses should come from Sinovac, but Galvez said no payment has been made yet and the country could opt not to purchase the vaccine if the Chinese firm would fail to secure regulatory approval. That approval should come from the Food and Drug Administration. 

During a Senate hearing, Finance Undersecretary Mark Joven explained that the term sheet with Sinovac states it will supply the country with 50,000 doses by February.

When will the vaccines be delivered?

The government expects Sinovac's CoronaVac vaccine to be the first to reach the country, along with doses from AstraZeneca and US drug maker Pfizer.

Although talks are still in the final stages with Pfizer, officials are counting on the global COVAX facility to grant the country’s request for early rollout.

Once approved, the vaccines will be given to the country for free. COVAX is a global initiative led by the World Health Organization with the vaccine alliance Gavi and the Coalition for Epidemic Preparedness Innovations, which aims to ensure equitable access to coronavirus vaccines.

The Pfizer vaccine boasts of a 95% efficacy rate.

It is the only brand so far that has been granted emergency use authorization by the Food and Drug Administration.

The FDA is still reviewing AstraZeneca’s application, while it is waiting for Sinovac to submit data on its phase 3 clinical trials.

The AstraZeneca vaccine, developed with the University of Oxford, has an average efficacy rate of 70%. Meanwhile, late-stage clinical trials in Brazil showed the Sinovac vaccine to be 50.38% effective against preventing coronavirus infection, falling below the previously announced 78%.

Phase 3 trial for the Novavax vaccine began at the end of 2020. Officials expect it to be available in the country by the third quarter.

Galvez said authorities will start inspecting all available cold storage facilities in the third week of January to ensure that no vaccines will be wasted. Vaccines made by AstraZeneca, Novavax, and Sinovac can be kept in standard refrigerators at 2 to 8 degrees Celsius – ideal for the existing cold chain system in the country.

Meanwhile, the government has bought 10 ultra-low temperature freezers mainly for the Pfizer vaccine, which needs to be kept at minus 70 degrees Celsius.

Other ongoing talks

Other vaccine makers the Philippines is in talks with include Janssen Pharmaceuticals, a US-based vaccine maker owned by Johnson & Johnson, American pharmaceutical firm Moderna, and Russia’s Gamaleya Institute. Galvez said the government is in the “advanced stages of negotiations” with these companies.

Philippine Ambassador to the U.S. Jose Manuel Romualdez said the country is close to procuring up to 20 million doses of Moderna vaccines.

Gamaleya, meanwhile, has informed the government it could provide 50 to 100 million doses of its coronavirus vaccine Sputnik V, Galvez said.

The national government is also working on getting more doses from AstraZeneca, aside from those bought by private companies and LGUs.

Clinical trials

Meanwhile, Filipinos could volunteer for clinical trials soon, after the FDA approved the applications of Janssen and China’s Clover Biopharmaceuticals.

These may start in the next few weeks after the vaccine expert panel identifies trial sites and participants are recruited.

Aside from these independent initiatives, the World Health Organization’s Solidarity Trial is slated for this month, but it remains unclear which vaccines it would test for efficacy. Galvez said it would enroll up to 15,000 volunteers, preferably from Metro Manila.

The capital region is the epicenter of the coronavirus outbreak in the country with more than 215,000 confirmed infections. This number forms a large portion of the almost half a million people who have tested positive for COVID-19.

The country remains under varying levels of community quarantine – all face-to-face classes suspended, business operations limited, and work-from-home setup encouraged. It is banking on the vaccination program to further open the economy, but health protocols should still be followed as it may take three to five years to inoculate enough people to achieve herd immunity.

This story will be updated as more information comes in.