The watchdog of global health is yet to award approval and licensure to the assortment of vaccines researched and produced to battle the Coronavirus, which ruptured the health system in 2019 and has continued to assail the globe at regular intervals with wave after wave of many of its “offshoots” since. It was only in December 2021 that the WHO listed the “10 Covid-19 vaccines for emergency use.”
According to the WHO it had given Emergency Approval to the below mentioned vaccines as listed by it:
WHO emergency use listing
The global health watcher in a communiqué stated that “emergency use listing (EUL) procedure” assessed the suitability of “novel health products during public health emergencies.” The aim was to make vaccines available as rapidly as possible to address the emergency while following stringent criteria of efficacy, quality and safety.
“The assessment weighs the threat posed by the emergency as well as the benefit that would ensue from the use of the product against any potential risks. The data was reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies,” it noted.
As part of the EUL process, the company producing the vaccine should commit to continue generating data enabling full licensure and WHO pre-qualification of the vaccine which assessed additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure that they met necessary standards of quality, safety and efficacy for broader availability.
Are coronavirus vaccines meticulously tested?
Why has the WHO even at the lapse of almost 32 month been unable to approve at least a single one of the vaccines that were produced to fight Covid-19? One would possibly think as to why the WHO was still dragging its feet with regard to giving at least one of the many assortments of vaccines approved licensure. Covid cases are still continuing to shoot up with bodies of dead Covid victims piling. WHO could seem to have enough evidence on any one of the vaccines’ quality safety and efficacy with some sections having not being vaccinated while those survivors have under gone three or more jabs of the coronavirus antibody builder.
According to the Food and Drug Administration (FDA) of the United States, “clinical trials are evaluating Covid-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed to determine safety and effectiveness.
The FDA’s methodology for vaccine approval “in phase- I, gives a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase- I studies, phase- II studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomised-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine.” During phase- III, the vaccine is administered to thousands of people in randomised, controlled studies “involving broad demographic groups such as the population intended for use of the vaccine, and generates critical information on effectiveness and additional important safety data.” It said that the this phase provided additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.
In the process
WHO Consultant and WHO Director-General’s Special Envoy for Covid-19 Preparedness and Response for the South East Asian Region (SEAR), Dr. Palitha Abeykoon observed the data collection process was currently in progress. There were a large number of vaccines that had been produced to beat the virus to consider. It involved mass research as there were thousands of people in each country on whom the vaccines had been used. Therefore the collecting of data would take time. Also, assessments had to be made as to the adverse effects etc., he noted.
Vaccine Development and goals
According to the FDA the goals of Phase – I testing aimed at assessing the safety of the candidate vaccine and determine the type and extent of immune response that the vaccine provoked.
Phase-II Vaccine Trials
A larger group of several hundred individuals participates in Phase – II testing. Some individuals may belong to groups at risk of acquiring the disease. These trials are randomised and well controlled, and include a placebo group.
The goals of phase – II testing are to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunisations, and method of delivery.
Phase-III Vaccine Trials
Successful Phase – II candidate vaccines move on to larger trials, involving thousands to tens of thousands of people. These Phase – III tests are randomized and double blind, and involve the experimental vaccine being tested against a placebo.
One Phase – III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine could occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include at least 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).
“The vaccine’s efficacy is also tested. The deciding factors may include
1. Does the candidate vaccine prevent disease?
2) Does it prevent infection with the pathogen?
3) Does it lead to the production of antibodies or other types of immune responses related to the pathogen?
The final step would be the ‘Approval and Licensure’ of the vaccine.
After licensure, however the FDA stressed that it continued to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity. The FDA has the right to conduct its own testing of manufacturers’ vaccines.
Locally, the National Medicines Regulatory Authority (NMRA) is tasked with monitoring the vaccine situation. As quoted earlier, the WHO has emergency approved several vaccines researched and produced by several countries with their own regulatory bodies which had no other option but to follow what may have seemed like a crash course to vaccine production as the pandemic squeezed and wrung the even the health services in developed countries.
Current vaccination trend
Locally health authorities have been urging the public to get their booster doses since the emergence of the Omicron BA.5 sub variant infecting the population while some foreign nationals working in Sri Lanka have been issued instructions by their relevant parent companies not to take the booster rolled out by the Sri Lankan Government.
But under the current do-or-die circumstances Sri Lanka is being put through owing to the bungling up of its economy, leading to more crises including a fuel crisis and a severe shortage of drugs coinciding with an increasing number of Covid infections the country cannot afford to sit around for WHO approval and licensure nor on the fear instigated on being administered vaccines, which had allegedly outworn their shelf life.
By Dilanthi Jayamanne