Experts warn of risks as pharmas race to develop vaccine

However, even as the world is waiting for the vaccine to protect themselves, experts say it would take about 12 months to 18 months to develop, conduct trials and mass produce it.

As of now, there is no approved treatment, much less vaccine, for COVID-19. Among the big firms, Johnson and Johnson had announced late last month that it has selected a lead vaccine candidate using the same technology that was used to develop vaccines for ebola and zika. Partnering with Biomedical Advanced Research and Development Authority (BARDA), an agency under the US Department of Health, the company is hoping to initiate human clinical studies by September and make it available for emergency by next year.

Similarly, Bharat Biotech in association with virologists at the University of Wisconsin-Madison and pharma firm FluGen has begun development and testing of a vaccine called CoroFlu, a one-drop COVID-19 nasal vaccine. It will build on FluGen’s flu vaccine called M2SR. Commenting on the developments, a city-based virologist said, “During pandemic crises like COVID19, pharmaceutical companies will develop and manufacture vaccine for emergency use. Of course, it has risks. They will have to follow the World Health Organisation (WHO) procedures and conduct numerous trials on animals before human trials. This was done during the ebola crisis when there was no medicine for the disease.” The expert added that preliminary evaluations would be done before testing it on patients, and they would be monitored round-the-clock to know the effects. “Companies will come up with large claims but we have to wait for their clinical trial stages to know about the vaccine and its effects. The WHO has a set of guidelines to follow during the development and manufacture of drugs to use in times of crisis before it gets approval from the authorities,” the virologist added.

Another virologist also cautioned that sometimes these announcements are made largely to boost investor confidence in the firm.

Speaking to DT Next, K Sivabalan, director, Tamil Nadu Drug Control Department said, “The State has no authority to approve. Any drugs that are under development should be approved by the Drug Controller General of India. They would test the new drug by analysing the risk-benefit ratio, and would approve if the drug benefits the patients. As of now, no drugs are at the stage for approval.”

A concern sounded by many experts across the world is the risk in fast-tracking efforts, particularly ‘vaccine enhancement’ where the vaccine makes the disease worse. It is not yet clear why this happens, but those who have been studying various coronaviruses say it particularly has this risk. Thus, there has not been any vaccine for any of the new coronaviruses that caused disease outbreaks in the last two decades.

According to a Reuters report, Dr Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, had part of an effort to develop a vaccine for Severe Acute Respiratory Syndrome (SARS), also a coronavirus that caused a major outbreak in 2003. He found that some vaccinated animals developed more severe disease compared with unvaccinated animals when they were exposed to the virus.

There are other cases, too in the past. In the 1960s, the trial conducted in the US for a vaccine against respiratory syncytial virus (RSV) found that a vast majority of babies who took it developed more severe disease – two even died. Recently in Philippines, about 8 lakh children were administered a vaccine for dengue, some of whom faced increased risk of more severe disease.