The intricate path towards a COVID-19 vaccine

Supercalifragilisticexpialidocious. It’s one of the longest words in the English language and it may mean something so wonderful and extremely good. Being so, one may relate it to the awaited coronavirus vaccine being developed — the long road towards something so extraordinarily beneficial to mankind now virtually paralyzed by the pandemic.

I had an enlightening talk in my Teleradyo program last Sunday with former Health Secretary Esperanza Cabral who described the arduous process in the frantic search around the world for a safe and effective vaccine which many hope would be the magic bullet to defeat COVID-19 and bring forth economic recovery.

While many vaccines for other illnesses took 10 to 15 years to develop, with the fastest at 4 years (for mumps), the world’s scientists and the entire pharmaceutical industry are now racing to develop within a year’s time the vaccine for SARS-CoV-2, the virus that causes COVID-19.

It’s possible to come up with such vaccine in less than a year, Dr. Cabral said, using a mix of new technologies and experience. Indeed, many reports point out massive efforts of research scientists have been “accelerated considerably by acquired knowledge developed during the generation of candidate vaccines for related SARS and MERS coronaviruses, as well as recent research into Ebola vaccines.”

Still, despite the urgent need to come up soonest with a product that protects against COVID-19 and its transmission, a vaccine must go through multiple stages — consisting of initial research and development, followed by a series of pre-clinical and clinical trials — before being approved for use by the general population.

The pre-clinical trial stage is when the vaccine is administered to animals to see if an immune response is triggered and to see how safe it is. But there are reports that for some coronavirus vaccines, “researchers have been able to speed up normal protocol by testing animals and humans in parallel.”

Dr. Cabral described the clinical trials which consist of three phases. In the first phase, the vaccine is given to a small group of volunteers, usually from 10 to 50 people. The second phase covers several hundred people, while the third and last stage consists of thousands or even tens of thousands of various ages in various locations.

All three phases are administered to determine the vaccine’s potential side-effects, immune response, dosage required, and to further gauge its safety, of course.

The US biotechnology firm Moderna was first in the world to start human trials last March 16, according to a CNN report last week. “Now there are six vaccines in the last stage of human trials (Phase 3) before they seek approval: Three from China — two developed by state-owned Sinopharm and one from private Chinese firm Sinovac Biotech; one from the United Kingdom produced in partnership between the University of Oxford and AstraZeneca; and two from the US, one by pharmaceutical giant Pfizer, in addition to the candidate by Moderna,” the report said.

But the first country to declare it had registered a vaccine and approved it for use is Russia, with President Vladimir Putin saying that one of his daughters had been inoculated. He said the vaccine, called “Sputnik V” after the Soviet-era satellite that was first launched into space, “works quite effectively, forms strong immunity… and has passed all the needed checks.”

However, the vaccine’s development process has raised concerns because, apart from being approved in Russia without undergoing the Phase 3 trial, no data on Phase 1 and 2 trials conducted by the state-run Gamaleya Research Institute have been subjected to peer review.

The Philippines will join Russia’s Phase 3 trial to be conducted from October, 2020, to March next year, according to Dr. Jaime Montoya, executive director of Department of Science and Technology Philippine Council for Health Research and Development (DOST-PCHRD), who said around a thousand healthy Filipinos from areas with high COVID-19 transmission will be selected.

Those joining clinical trials are not paid, according to Dr. Cabral. But they will be compensated for time lost from their work. They will be covered by medical insurance to ensure free treatment if they get sick and there will be compensation for deaths resulting from the trial.

But it remains to be seen how Filipinos would be willing to be part of the Russian Phase 3 trial amid President Duterte’s declaration that he wants to be a volunteer.