The government is calling on Filipinos to take part in clinical trials, especially one that is already ongoing and two others that are set to start soon, as a way of helping produce an effective vaccine for COVID-19.
Janssen Pharmaceuticals, which is based in Belgium and owned by Johnson & Johnson, has started its clinical trial in the Philippines for its single-shot vaccine.
Two Chinese companies, Sinovac Biotech and Clover Biopharmaceutical, are in the final stages of preparations for their trials in the country.
“We encourage our countrymen to join clinical trials if your barangay is chosen as one of the sites of the clinical trial, because we need to find a vaccine that is effective and safe and efficacious,” said Undersecretary Rowena Guevara of the Department of Science and Technology (DOST).
At the moment, Janssen is recruiting and screening participants, said Guevara.
Those who would pass the screening would be given the vaccines and their condition would be monitored, she said.
Adverse effects
In case of adverse effects in independent clinical trials, the vaccine developers would shoulder the cost of treatment, she said.
In the case of the World Health Organization (WHO) solidarity trial, the WHO would provide global insurance to the volunteers.
The Philippine government would not shoulder any of the costs, Guevara added.
The DOST earlier said Janssen would likely conduct trials in the cities of San Pablo and Cabuyao in Laguna province, La Paz in Iloilo province, and Metro Manila.
Johnson & Johnson said Janssen’s vaccine was found to be 72-percent effective in its United States trials.
The company also said the vaccine was “85-percent effective overall in preventing severe disease and demonstrated complete protection against COVID-19-related hospitalization and death as of Day 28.”
Janssen’s vaccine is a single shot unlike the vaccines produced by Pfizer and AstraZeneca, which require two jabs to be fully effective.
Presidential spokesperson Harry Roque on Saturday said the delay in the delivery of the Pfizer and AstraZeneca vaccines was due to their requirement of a government assurance that they would not be hailed to court in the same way that Sanofi Pasteur was following the Dengvaxia fiasco.
Indemnification fund
“All of us are getting impatient. But the manufacturers, Pfizer, Astrazeneca, became afraid and want to have assurance that what happened to Dengvaxia would not happen to them, when the manufacturer of that vaccine was sued,” Roque said during his appearance at a television noontime show.
Secretary Carlito Galvez Jr. on Thursday said that it already had an indemnification agreement with AstraZeneca.
“For the information of everyone, in our initial negotiations, Pfizer wasn’t asking for that, just only now, that’s why we were a bit surprised because the only one that insisted on what we call indemnity clause was Johnson & Johnson,” Galvez said.
Health Undersecretary Maria Rosario Vergeire on Saturday said the passage of a law creating an indemnification fund would speed up negotiations for COVID-19 vaccines.
Vergeire said the indemnification agreement with vaccine manufacturers was the main challenge for the country at the moment.
Urgent measure
President Duterte certified as urgent the measure to create an indemnity fund to help those who would experience adverse effects from the COVID-19 vaccines.
Speaker Lord Allan Velasco has committed passage on Monday of his House Bill No. 8648, which provides, among others, an indemnification fund.
Vergeire explained that all drug manufacturers required an indemnification agreement because the vaccines were still under development, and they would not want any liability for their emergency use.
Other countries already have existing laws for indemnification, she noted.
“The reason we are having more difficulty in negotiation is because we do not have a law to support this indemnification agreement. This is why we are urging Congress to approve this law so that the negotiations would move more quickly,” Vergeire said at Saturday’s Laging Handa briefing.
Informed consent
But while the law is not yet in place, she said the Philippines negotiated with vaccine manufacturers to come up with specific documents to address their concerns, such as the informed consent form that would include the liability waiver statement.
“We are ensuring [to] them that no liability will be charged against them in case there would be adverse events,” she added.
Once the indemnification agreement has been ironed out, and especially if the indemnification fund law has been passed, negotiations with vaccine manufacturers and with the COVAX facility would move swiftly, Vergeire said.
“And that would facilitate the arrival of the vaccines into the country,” she added.
Vergeire also said the Dengvaxia issue was “beside the point.”
—With a report from Julie M. Aurelio