DCGI nod for Covid-19 vaccines: Doctors give thumbs-up, but flag minor issues

DCGI, apex drug-regulating body, on Sunday approved the Oxford-AstraZeneca vaccine ‘Covishield’ and Bharat Biotech’s Covaxin for restricted emergency use in India

The Drugs Controller General of India (DCGI) on Sunday approved two Covid-19 vaccines for restricted emergency use in India. Doctors across the country have given a thumbs up to the decision, but have also flagged ‘minor issues’ that need to be addressed in the long run.

Vials of AstraZeneca's Covishield, as are packaged inside a lab at Serum Institute of India, in Pune. (REUTERS)

In the state, over 19 lakh people have been infected with the Sars-CoV-2 virus that causes Covid-19, since its outbreak in March 2020. Almost 50,000 have succumbed to the virus and over 80% of them are above 50 years of age. Scientists around the globe have been racing not only to find a cure, but also a vaccine to stop the chain of reaction. Finally, after days of waiting, DCGI, apex drug-regulating body, on Sunday approved the Oxford-AstraZeneca vaccine ‘Covishield’ and Bharat Biotech’s Covaxin for restricted emergency use in India. But fear and anxiety among public clouds the landmark day in medical history.

“How can I trust the efficiency of the vaccine? It generally takes 10-12 years to produce a vaccine. Whereas, this vaccine which hasn’t even cleared the third trial, gets approval. We might be a mere guinea pig in their experimentation,” said Shruthi Mishra, 27, an architect and resident of Borivli.

Vaccine is the only hope

To answer this question, Dr Rajesh Mishra, general secretary at Indian Society of Critical Care Medicine, said new advanced technology has helped shorten the time process of identification of the virus and production of its vaccine. “In 2009, when the swine flu pandemic started, within six-seven months, the vaccine was produced. Now, after 11 years of it, why is it so surprising that we have been able to produce a vaccine within a year? We are yet to get a few answers about the longevity of the vaccine, but at present, at least, it will help to stop the chain of reaction,” he said.

Dr Anthony Fauci, the top United States (US) infectious disease expert, told The Associated Press, “The speed is a reflection of years of work that went before...That’s what the public has to understand.”

To fight with any pandemic, it is essential to attain mass immunity as also called herd immunity to stop the spread of the virus through a chain reaction. “This can be done through two ways- natural herd immunity, where a substantial part of the society contracts the virus and develops immunity. But this can lead to a large number of deaths of the infected patients. Secondly, it can be achieved through vaccination. At present, it is our only hope to bring back life to normal,” said Dr Dhruva Chaudhry, head of the department, pulmonary and critical care medicine, University of Health Sciences Rohtak and Haryana’s nodal officer for Covid-19.

Another important thing that has been highlighted by doctors is that Covishield is a vector-based vaccine and the chance of acquiring Covid-19 is zero. “The Covishield vaccine has been produced by taking a part of a viral vector-borne disease to produce antibodies in our body. Also, Covaxin is an inactivated intramuscular vaccine where the inactivated (killed) version of Sars-CoV-2 is injected to produce antibodies. Thus, the beneficiaries cannot get infected with Covid-19 from the vaccine,” said Dr Deepak Baid, president of Association of Medical Consultants (AMC).

Dr Baid who was also part of the dry run trial at the civic-run Rajawadi Hospital on Saturday said, “These vaccines are logistically more viable as it doesn’t require -70-degree Celsius refrigerators for preservation.”

Citizens are also questioning the need for two dosages. Experts opine that the first dosage just induces the antibodies. While the second dosage, boost the antibodies.

‘No severe side effects’

In August, during the first phase of the trial, an adverse effect of the vaccine was reported. A patient was hospitalised after receiving a dose of the Covaxin. The issue was reported to the Central Drugs Standard Control Organisation-Drug Controller General of India (CDSCO-DCGI), within 24 hours of its occurrence. “The adverse event was investigated thoroughly and determined as not vaccine-related,” the spokesperson of Bharat Biotech said in a statement.

On September 6, AstraZeneca which is developing a Covid-19 vaccine—Covishield along with the University of Oxford, temporarily had to halt the phase 3 trials around the globe, after a participant reportedly developed severe adverse reactions. Later, the company resumed clinical trials of its coronavirus vaccine candidate after confirmation from the regulatory authorities that it was safe to do so.

Doctors sharing their personal experiences said they haven’t witnessed any severe reaction among volunteers. “Several of my doctor friends in the US and UK have taken the two dosages but none has witnessed any serious adverse effect. It would have been impossible to hide such incidences from media and drug regulating bodies,” said Dr Mishra.

Dr Chaudhry sharing a recent incident stated that one of the professors from his university took part in the clinical trial. Following which, she complained of uneasiness and discomfort. “She had a 99’F fever with body ache. But with paracetamol, she recovered within a day,” he said. “So, people may develop a few reactions, but its severity will be extremely minor,” he added.

“The vaccines have been certified 100% safe, however, some side effects like mild fever, pain and allergy are common for every vaccine, so do not worry and get your vaccine shot,” said Dr Rahul Pandit, director-critical care, Fortis Hospitals, Mumbai, and member of state’s Covid-19 task force.

Doctors flag minor issues

However, doctors demand a few questions be answered which are still unknown to the medical fraternity. For instance, the questions include how long the vaccine remains effective, whether already infected patients need to take the vaccine, how many doses a patient with the history of infection needs to take, how it will work on children, pregnant women and immune-compromised patients.

“We still need clarity on how long the vaccine-induced immunity will last in our bodies. Also, it is unclear if a beneficiary can be a carrier after some months of the vaccination,” said Dr Mishra.

There is also a confusion among the public and doctors if people with a history of Covid-19 infection, need to take the dosages. Citing an example, Dr Chaudhry said that he (53-year-old) contracted the infection in July. It has been five months since the infection. Now, he is puzzled if he needs to get vaccinated. “Even if I get vaccinated, I am not sure if I should also get the second shot,” he said.

Also, there is no clarity if immune-compromised patients can undertake the vaccine. “We have to optimise the vaccine for such patients. The dosages have to be defined as per their need,” said Dr Chaudhry.

Dr Pandit said those with compromised immune systems need to first take approval from their doctors before they take the vaccine shot. “As of now, no data is available for vaccination of children and pregnant patients; an advisory in the UK suggested that pregnant patients can take the vaccine only if they are at a high risk of contracting the disease and that it should be taken as late in pregnancy as they can,” he said.

Doctors also emphasized on conducting long-term research and epidemiological studies to understand its sustainability.

Dr Chaudhry which calls this as an ‘urban phenomenon’ states that already overcrowded slums like Dharavi have developed antibodies among over 60% of the population. “So, we need epidemiological studies to decide if we need to include urban or slums into the list of priority for vaccination,” he added. In the third phase of Covaxin, 30% of the volunteers have been selected with above 50 years of age, he said.

Senior state health officials said that to earn the trust of the public, the manufacturers need to bring more transparency. “We know that Covishield has 70% efficiency rate, which is fine, as no vaccine can provide 100% protection against any virus. But we still don’t know about the efficiency rate of Covaxin. We are still unaware if we can vaccinate health workers with severe comorbidities. These things need to be cleared so that we can also convince people to come forward for vaccination. It is a voluntary process and we can’t force anyone to get vaccinated,” said the officer.