Clinical trials continue as the world waits for the COVID vaccine

• The protocols for starting clinical trials
• Volunteers are selected and monitored
• There is a Data Security Monitoring Board (DSMB) that bypasses the test
• The WHO Solidarity Trials will last 18 months; Sputnik V tests will last 3-6 months
• About 1,000 Filipinos will take part in Sputnik V phase 3 clinical trials

The figures related to the coronavirus disease (COVID-19) pandemic are alarming: around 29 million cases worldwide with a death toll of 917,000, according to the World Health Organization, as of September 14. Add to that the WHO also recorded 307,930 new cases in 24 hours worldwide, the highest number of new cases yet.

As the numbers continue to rise, scientists and researchers around the world are working tirelessly to produce a vaccine, many of them now in the final stages of clinical trials.

What is the process for conducting clinical trials, how are participants selected, and what happens during the clinical trial period? Here’s a look at the processes being carried out in the Philippines and in many parts of the world on the road to producing a safe and effective vaccine against COVID-19.

First, FDA approval

All candidate vaccines must go through a regulatory process before they can be tested in the country.

DOH Undersecretary Mario Rosario Vergerie said that approval from the Food and Drug Administration (FDA) and the ethics review board must first be secured before conducting any vaccine trials, whether by local sponsors or developers. or international.

“The government needs to regulate [these initiatives] so that we can make sure it is safe for our compatriots. If we don’t go through this process, we cannot be sure that it is safe and could cause harm to our citizens, ”said Vergerie in Pilipino.

Approval of a trial request would take 45 to 60 days, said Jesusa Joyce Cirunay, director of the FDA’s Center for Drug Regulation and Research.

Recruiting volunteers

Dr. Jaime Montoya, infectious disease expert and executive director of DOST – Philippine Council for Health Research and Development (DOST-PCHRD), explained the system for recruiting volunteers for clinical trials. He said it is based on selection criteria related to the protocols established by vaccine developers. This also serves as a guide for the characteristics of the volunteers who will participate.

“They have target age groups, you can also see what kind of people they are targeting, for example healthcare workers, frontline workers, hospital or community workers (they have a target age group, or the type of people needed, be it a healthcare worker, a frontline worker, a hospital worker or simply a person within a community, ”explained Montoya.

He explained that the important thing is that the selection is not random.

It is also important that there is an informed consent (FPIC).

“Participants will be explained what the clinical trial is, what the product is, what the possible effects are, why it is given, and what can happen when you participate (participants are told what the clinical trial is about, the product, the possible effects, the reason it is given and what will happen during the trials), ”said Montoya.

Montoya emphasized that participation in clinical trials is voluntary. If they agree, they sign and join.

Compensation

Are volunteers compensated for participating in clinical trials?

Dr. Montoya said they are given a small amount for food and in some cases transportation when they need to go to an area far from their residences.

“But we must bear in mind that this amount is not huge. This is to prevent people from participating without fully understanding the meaning of their participation and it may only be for the money, ”explained Montoya.

“That’s what we call ‘undue incentive’ and we don’t want that to happen,” Montoya said.

Clinical trials

Dr. Lulu Bravo, executive director of the Philippine Foundation for Vaccination, said that people involved in the trials will be monitored from the time they are given the vaccine to five years later, depending on safety concerns.

“There is a Data Security Monitoring Board (DSMB) that bypasses the trial and can stop the trial at any time if there are concerns, or continue the trial after certain numbers have been entered,” said Dr. Bravo .

The World Health Organization Solidarity Trials, which have yet to announce the vaccines to be used, will last 18 months, while the Phase 3 Clinical Trials of Sputnik V, the Russian vaccine, will last three to six months.

Sputnik’s phase 3 clinical trials and solidarity trials are different in method and scope.

According to the secretary of the Department of Science and Technology, Fortunato dela Pena, about 1,000 participants are needed for the WHO Solidarity trials, since about 80 countries will be part of them. The Philippines participates in Solidarity tests.

Sputnik, the Russian vaccine candidate, will conduct phase 3 clinical trials to test efficacy and monitor adverse reactions. There will be about 1,000 Filipinos who will take part in phase 3 clinical trials.

Dr. Bravo, who has been a part of conducting vaccine trials in the country for 30 years, said there was no case of a participant dying during a vaccine trial.

“There is always a liability clause in the informed consent that all volunteers sign before trial … there is insurance … it depends on DALY and age, etc.,” said Dr. Bravo. (Disability Adjusted Life Year (DALY) is the calculated number of years of life and income that a person loses if they become disabled.)

“People who have been to vaccine trials often ask when the next one will be so they can include their friends and family. In other words, they are happy to have been cared for and to receive the highest quality care during the trials, ”he added.

External policies on clinical trials

China is currently testing 16 different candidate vaccines, according to data from the London School of Hygiene and Tropical Medicine. After China are the United States with 11 ongoing trials and Russia with six.

According to the ClinRegs website of the National Institute of Allergy and Infectious Diseases (NIAID), clinical trials in China must first undergo a review by the regulatory authority and the ethics committee before conducting them.

Approval of a clinical trial in China takes 60 business days, according to the Backer McKenzie (Asia Pacific) Clinical Trials Manual.

In the United States, regulation of vaccines is done by the Food and Drug Administration (FDA) Center for Biological Products Evaluation and Research. All new vaccine sponsors in the US must go through a “multi-step approval process.”

“Information on the safety and ability of the vaccine to elicit a protective immune response in animal tests is also included, as is the proposed clinical protocol for human studies,” said the US FDA.