The speed of COVID-19 vaccine development is an extraordinary feat

MANILA, Philippines – In less than a year, scientists were able to develop candidate vaccines against COVID-19, raising hopes that the end of the pandemic is near, even as health experts still call for caution.

This extraordinary feat, however, is being undermined by an avalanche of falsehoods that even the social media giant Facebook took note of as it pledged to “remove false claims” about coronavirus vaccines on its platform.

It usually takes years, even decades, for the scientific community to develop a vaccine against an infectious disease.

Tests, trials

Take the case of measles, which has affected humanity for centuries. It was only in 1963 that the first measles vaccine was licensed in the United States.

In contrast, the development of at least three candidate vaccines against COVID-19 only took 11 months since the World Health Organization (WHO) first learned on December 31 of last year of a cluster of pneumonia cases. unknown cause in Wuhan, China.

These vaccines were developed by Pfizer / BioNTech, Moderna / US National Institutes of Health (NIH), and Oxford / AstraZeneca.

WHO chief scientist Soumya Swaminathan explained that just because these vaccines came out in record time does not mean that there were steps in the scientific process to develop a vaccine that were missed.

He noted that all of these vaccines underwent preclinical testing as well as three-phase human clinical trials.

‘Security data’

“The timelines were sped up by overlaying Phase 1 and 2 by regulatory agencies willing to be flexible, looking at the submissions, so even before Phase 1 is completed they are ready, if all goes well, to approve the Phase 2, ”Swaminathan said.

She noted that “that doesn’t normally happen with vaccine or drug development.”

In the first two phases of clinical trials, the safety, efficacy, and appropriate dose of the candidate vaccine are tested in up to 1,000 patients.

Swaminathan said it also helped that substantial investments have been made in vaccine development, along with recent advances in science and technology.

“So it is based on scientific progress in recent years. It is accelerating clinical trials by overlapping and also investing in manufacturing, ”he said.

Emergency use

Philippine infectious disease expert Dr. Edsel Salvana said another reason for the speed of vaccine development is that many of them were based on “known technology and reused SARS and MERS vaccines that were in advanced stages. developmental”.

“Despite the urgency of the matter, the US Food and Drug Administration (FDA) still required at least two months of safety data from tens of thousands of patients before even considering a vaccine for review. These patients will continue to be followed for longer-term side effects even after the vaccine is approved to get an idea of ​​longer-term problems, if any arise, ”Salvana said in a Facebook post. .

This week, President Duterte gave the FDA the power to grant an Emergency Use Authorization (USA) to candidate COVID-19 vaccines. Manufacturers are issued an EUA, especially in times of health emergencies, and when the benefits of using a vaccine or drug candidate outweigh its risks.

FDA CEO Eric Domingo noted that an EUA does not exempt a manufacturer from fully completing its vaccine development.

Once an EUA is issued and the vaccine is implemented in the country, Domingo said that both the FDA and the Department of Health (DOH) will conduct post-authorization monitoring for side effects, if any.

He said this mechanism also ensures that when there are “unusual or suspicious adverse events,” these can be investigated immediately and they can decide whether to continue with further vaccination.

“It is really important to have a very strong monitoring and surveillance mechanism, both passive and active,” said Domingo.

Based on the results of their clinical trials, the vaccines developed by the top three manufacturers were found to have varying degrees of efficacy.

Pfizer / BioNTech reported that their vaccine had a 95 percent efficacy rate, while the Moderna / NIH US vaccine was at 94.1 percent. The Oxford / Zeneca vaccine has an average efficacy rate of 70 percent.

According to Domingo, the efficacy of a vaccine may differ from published efficacy rates, as their data were based on trials conducted in a well-controlled setting.

Factors that can affect the efficacy of a vaccine in the real world setting are uncertainties in the cold chain and patients who cannot strictly follow their vaccination schedule, among others.

“Effectiveness is the real-life application of the efficacy of a vaccine. [The efficacy rate] it is the result that we can expect if we use the vaccine in the correct and prescribed way ”, he said.

Virus case update

On Saturday, DOH recorded an additional 1,733 cases of COVID-19, raising the national count to 438,069.

Davao City reported the highest number of new infections, 162, followed by Quezon City (92), Benguet (80), Rizal (70) and Laguna (66).

Another 133 patients have recovered from COVID-19, bringing the total number of survivors to 399,582. The death toll, however, rose to 8,526 when 17 patients succumbed to the severe respiratory illness.

Recoveries and deaths left the country with 29,961 active cases, of which 86 percent are mild, 6.7 percent asymptomatic, 0.27 percent moderate, 2.4 percent severe, and 4.6 critical percent.

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