The State of Vaccine in India

 India's top drug regulator on 3 January approved Covishield and Covaxin as vaccines for restricted use against Covid-19, paving the way for mass vaccination against the virus that has so far infeed over a crore people and killed nearly 1.5 Lakh. A look at these Vaccines, how they were approved and what this means for the population.

 

How does Covishield work?

 Covishield is a pharmaceutical company Serum Institute of India's version of the Oxford - Astrazeneca vaccine that was approved by the UK Government. Covishield known as CHAdOxln Cob-19 or AZD1222, the vaccine is based on a weakened version of a common cold virus or the adenovirus that is found in Chimpanzees. The viral vector contains the genetic material of the SARS -Cov-2 spike protein – protrusions present on the outer surface of the virus that helps it blind with the human cells.

 As with most vaccines, the Oxford - AstraZeneca version produces the mimic spike protein that then triggers an immunological reaction which would effectively Prime the immune system.

 From the phase 1 trial of the vaccine, researchers had concluded that two doses of the vaccine a month apart, would offer the best protection. But a dosing error in the third phase of clinical trials led to participants receiving a half dose and then a full dose , which actually proved to be 90 percent effective, In case of those who received two full dozes, the efficiency was 62 percent.

 Since the cohort that received this combination was considerably smaller with no participants over the age of 55, AstraZeneca announced that it would conduct another global trial. They were also administered the half dose followed by a full dose. The regulator board in the UK has allowed the vaccine to be administered in two full doses with an interval of 12 weeks.

 Controversy with Covishield

 The Covishield vaccine trial in India became mired in a controversy last month after a 40-year-old volunteer allegedly suffered serious neurological impairment. The trial participant sent a legal notice to SII and warned the company of legal action if it didn’t stop the vaccine’s trial immediately and suspend all plans for its “manufacture and distribution”. Earlier this month, it was reported that the volunteer had decided to move court against SII.

 

How does Covaxin work?

 The Indian company Bharat Biotech partnered with the National Institute of Virology and the Indian Council of Medical Research to develop an inactivated coronavirus vaccine called Covaxin. India authorized the vaccine for emergency use on Jan. 3, despite a lack of published Phase 3 data showing the vaccine is safe and effective.

 Covaxin is made of an inactivated vaccine, meaning the vaccine is made up of the virus that has been killed and can no longer cause infection. When injected into the body, immune cells can still recognise the virus, even though it is inactivated, which is what triggers an immune response.

 On 22 December, Bharat Biotech published data from its phase 2 trials. The data showed that the vaccine was safe with no serious adverse effects having been observed. The study also “hypothesized” that T-cell and B-cell immunity generated from the vaccine “may persist until at least 6-12 months after the second vaccination dose.”

 Controversy with Covaxin

 Experts have raised doubts over the restricted emergency approval granted to Bharat Biotech’s Covaxin by DCGI in the absence of phase 3 trial data. While the panel is believed to have considered the phase 3 data of Covishield UK trials, no such data of phase 3 trials is available for Covaxin.

 Many experts have also expressed concern over the DCGI’s quick approval after the Subject Expert Committee’s recommendation. Experts say that ideally, any approval should be granted after analyzing the phase 3 data on the efficacy of the drug.

 

Who Will Get Covid-19 Vaccine First

 1. Healthcare workers: Public and private

The vaccine will first be given to around one crore healthcare workers working in both government and private hospitals, according to the recommendation by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). These healthcare workers have further been divided into sub-categories - frontline health and Integrated Child Development Services (ICDS) workers, nurses and supervisors, medical officers, paramedical staff, support staff and students.

 2. Frontline and municipal workers

 Around two crore frontline workers associated with the state and central Police department, armed forces, home guard, disaster management and civil defense organisation, prison staff, municipal workers and revenue officials engaged in COVID-19 containment, surveillance and associated activities are next in line to get the vaccine. Workers associated with state government and ministries of defense, home, housing and urban affairs will also be inoculated in this phase.

 3. Population above 50 years of age

This group is divided into two sub-categories: Above 60 and 50-60 years of age. The latest electoral roll for Lok Sabha and Legislative Assembly elections will be used to identify the population under this category for the vaccination drive.

 4. Areas with high COVID-19 infection

 States and Union Territories will have the generic flexibility to do priority phasing of the rollout for the identified priority groups (as decided by the NEGVAC) in identified geographical areas where the COVID-19 infection prevalence is high.

 5. Remaining population

 The remaining population will be inoculated after the people in priority list are covered. The vaccination here will depend on the disease epidemiology and vaccine availability. To avoid overcrowding at vaccination session site, the vaccine will be given to the beneficiaries in a staggered manner.

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