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Race for vaccines: Long wait for FDA

While nine vaccines for COVID-19 are racing to the finish line around the world, the Food and Drug Administration (FDA) said it has yet to receive any applications from vaccine manufacturers to hold phase 3 trials in the Philippines.

“No vaccine has reached the FDA for a clinical trial application for a COVID-19 vaccine,” said FDA Director General Eric Domingo.

Neither Russia's Sputnik V vaccine nor the ones being developed by Johnson & Johnson or China's Sinovac have reached the FDA review panel.

Domingo said once the applications arrive, vetting would be done by an expert panel with a target to begin clinical trials by the end of October.

At this rate, he added, a vaccine would be likely rolled out in the middle of next year.

Phase 3 is the longest part of vaccine development that typically takes five to six months and involves thousands of people. However, he noted passing phase 3 is not a guarantee that a vaccine is effective.

In his presentation during an online seminar on vaccine development, Domingo cited the need to ensure the full protection of human rights and the safety of human subjects and integrity of the clinical trial data.

He said the FDA would release its decision on an application within 60 calendar days.

Meanwhile, Pharmaceutical Association of the Philippines (PHAP) President Teodoro Padilla said their members would be keen to make sure that Filipino patients have access to the COVID-19 vaccines.

But all vaccine manufacturers will still have to go through the clinical trials and would have to be registered with the FDA for clearance and approval.

Meanwhile, UP Professor Dr. Josefina Carlos said that as of Sept. 22, 38 candidate vaccines are in clinical evaluation, 149 in pre-clinical evaluation and nine are in phase 3 clinical trials, six are in phase 2 clinical trials and 24 in phase 1 or 2.

She noted, however, that it would take years to completely ensure the vaccine is safe and effective.

Meanwhile, the New York Times reported that while the world still lacks a proven coronavirus vaccine, Chinese officials are inoculating tens of thousands, if not hundreds of thousands, of people outside the traditional testing process. Three vaccine candidates are being injected into workers whom the government considers essential, along with many others, including employees of the pharmaceutical firms themselves, the Times reported.

Officials are laying out plans to give shots to even more people, citing emergency use, amounting to a big wager that the vaccines will eventually prove to be safe and effective.

No other country has injected people with unproven vaccines outside the usual drug trial process to such a huge scale. The unproven vaccines could have harmful side effects. Also, ineffective vaccines could lead to a false sense of security and encourage behavior that could lead to even more infections.

Topics: COVID-19 , Food and Drug Administration , Vaccine , Pharmaceutical Association of the Philippines , Theodoro Padilla
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