Coronavirus vaccine Covaxin found safe and side-effect free in Phase I trials: Here's why it is a GOOD NEWS!

While COVID-19 cases continue to surge across India, the race for developing a promising home-grown vaccine has only amplified in the country. Trials for as many as three vaccines are going on in research facilities across India and are still in the nascent stages. Covaxin, one of the prime candidates in this race was one of the first to win approvals, and reach phase II trials. Recent reports now suggest that the vaccine, which has been developed using an inactivated virus shows no side-effects so far.

The report comes as researchers prepare to start phase II trials of the vaccine at different centres. Doctors at Institute of Medical Sciences and SUM Hospital, faculty of medical sciences collected blood samples of volunteers who were dosed with the experimental shot of the vaccine developed by Bharat Biotech International Limited, National Institute of Virology, Pune in collaboration with Indian Council of Medical Research.

According to one of the doctors responsible for conducting the trials, Dr E Venkata Rao, participants recorded a spike in the production of antibodies soon after receiving the dose. Lab samples also found that participants did not suffer from any side-effects after the inoculation.

The positive news comes soon after the country's health minister, Dr. Harsh Vardhan said that he expects the pandemic to be under control in the country in the next couple of months. Government officials have also held meetings with important stakeholders to prioritize the production, marketing and administration of vaccines in the coming months.

"We are expecting vaccines to be ready by the end of the year. It is because of the farsightedness of Prime Minister Narendra Modi that we could reach until here,”

This is not the first time positive safety data has been observed in Covaxin trials. Early reports emerging out of Rohtak, which was selected as a trial centre said that the vaccine was able to elicit safe immunogenicity response and resulted in no considerable side-effects.

Globally, prime vaccine contenders like Oxford University's candidate, Moderna Inc., CanSino have detailed the existence of certain side-effects in early trials.

Blood samples of the participants have been collected and underwent analysis to study the effects, two weeks apart, as per the dosing schedule. The samples will also be collected on later days (28, 42, 104, 194) for conclusive evidence.

Dr E.V. Rao commented saying, "Two doses of the vaccine were administered to each volunteer after they were selected through a screening process conducted over a period of three to seven days prior to vaccination. The first dose was administered on Day Zero while the blood sample was collected. The second dose was given on Day 14 and the blood sample was also collected,"

He also said that there is still active participation needed from the public for the second leg of the trial, which is a crucial component before any vaccine heads for public use. It is being speculated that India will see the launch of Covaxin, or any other Indian vaccine by the end of December.

The reports of Covaxin being side-effect free is indeed good news. It can be common for a vaccine to induce side-effects in the early stages of testing. Scientifically, vaccines can carry a "reactogenic" effect post-administration, meaning that the participants who are dosed with the vaccine can experience mild symptoms or short-term discomfort, which has, so far, been observed in people who have been a part of COVID-19 clinical trials. The range of discomfort causing symptoms can range from mild pain, dizziness, fever, fatigue, muscle pain, sore arms and chills

Knowing the shortcomings and possible side-effects beforehand can prepare us for the future. It can also help rule out the shortcomings which can arise with vaccine delivery, especially when administered to the higher-risk categories. It should be noted that no other information, including the health parameters of the participants involved, have been revealed so far.

That being said, it is still early to speculate that Covaxin, is indeed, safe for mass inoculation and prevents SARS-COV-2 virus. While phase II trials are to start soon, a properly spread out phase III trials will be a better measure to study the advantages and disadvantages of the vaccine.