Bharat Biotech, the makers of Covaxin, on Monday advised people not to take the coronavirus vaccine if they have allergies, fever or bleeding disorder or are on blood thinners. In a fact sheet about the process involved and who should avoid taking the vaccine, the Hyderabad-based pharmaceutical firm added pregnant and breastfeeding women to the list of people who should avoid taking Covaxin shots.

Bharat Biotech reiterated that the Drug Controller of India has authorised the restricted use of its vaccine under clinical trial mode. “Individuals who are prioritised under the public health program of the ministry of health and family welfare will be covered under this endeavour,” the fact sheet read. “Informing the individuals about the offer for vaccination with Covaxin will rest with the respective government program officials. Those offered Covaxin at pre-specified booths will have the options to receive or reject administration of the vaccine.”

Credit: Bharat Biotech

Bharat Biotech’s fact sheet was released at a time when Covaxin has faced reservations from various sections, including the Congress, for being approved even before data for the third phase human trials was published.

On Saturday, resident doctors of Delhi’ Ram Manohar Lohia Hospital demanded that they be given the Covishield vaccine instead of Covaxin as the former has completed its Phase 3 trials. The Serum Institute is the local maker of the other vaccine, Covishield, developed by Oxford University and pharmaceuticals company AstraZeneca. The doctors also said that they would not participate in the vaccination process if they are administered the Bharat Biotech vaccine.

However, Indian Council of Medical Research chief Balram Bhargava had defended the decision to grant approval to the two vaccines.

Giving details of the ingredients used in Covaxin, Bharat Biotech said: “The vaccine thus has been developed by using inactivated/killed virus along with the aforementioned chemicals.” Both Covaxin and Covishield are administered as an injection into the muscle of the upper arm. Both are two-dose shots given four weeks apart.

Serum Institute, the Indian manufacturer of the Oxford-AstraZeneca vaccine, had also released a fact sheet on January 1. It listed the ingredients of the vaccine and said that the people who had a severe allergic reaction to any of them should not get inoculated. The fact sheet added that pain at the injection site and headaches were among the very common side-effects of the vaccine.

We will need as many vaccine shots as we can get: AIIMS director

Meanwhile, All India Institute of Medical Sciences Director Dr Randeep Guleria blamed an infodemic and social media posts on the adverse events of vaccination for an increase in hesitancy against the shots among the public. “We will need as many vaccine shots as we can get because the number of people we need to vaccinate is humongous,” he told the Hindustan Times in an interview. “We may keep arguing about which one is good, but at the end of the day, any vaccine that is safe and provides efficacy will help in saving lives and bringing down mortality.”

Guleria added that the current focus should be on saving lives, breaking the chain of transmission and getting the economy back on track. “This is the final phase of our fight against Covid-19,” he said. “Looking back, there is satisfaction that we managed without going into a chaotic situation, with people running out of beds and oxygen that we hear from some other countries.”

India’s vaccination drive

India, which has reported the highest number of coronavirus infections after the United States, plans to vaccinate around 30 crore people with two doses in the first six to eight months of the year. The recipients include 3 crore doctors, nurses and other front-line workers, to be followed by people who are either over 50 or have illnesses that make them vulnerable to Covid-19.

The Union Health Ministry on Monday said that 580 adverse events following immunisation were reported across the country since India’s coronavirus vaccination drive began on January 16. An adverse event following immunisation, or AEFI, is any unexpected medical occurrence following inoculation but may or may not be related to the vaccine or the vaccination process. A total of 3,81,305 beneficiaries have been vaccinated till Monday evening.

The ministry added that seven people needed hospitalisation and two people died following the inoculation. However, the government pointed out that the deaths were not related to the vaccination. A 46-year-old health worker in Uttar Pradesh’s Moradabad district died on Sunday evening, a day after being administered a coronavirus vaccine. The second person who died was a resident of Bellary, Karnataka.

Beneficiaries, however, will not be able to choose between the Oxford University-AstraZeneca Covishield vaccine, produced by the Serum Institute of India, and Covaxin.