TATA Group's newly launched medical venture Tata Medical & Diagnostics is reportedly in talks with Moderna to bring its COVID-19 vaccine to India after conducting clinical trials to ensure its safety and efficacy. The Economic Times reported that the dialogue is still in its early days and that sources have said that the company would partner up with the Council of Scientific & Industrial Research (CSIR) to carry out the necessary clinical trials of Moderna’s vaccine candidate in India.
The Director-General of CSIR Shekhar C Mande told The Print, "We are in talks with Moderna to understand the science behind their vaccine and how it works on the human body. Till now, the discussions are scientific in nature".
The Centre for Cellular and Molecular Biology (CCMB) in Hyderabad has the capacity to develop this vaccine very quickly – within weeks, Mande said.
When asked about Indian pharma companies interested in, Mande said “I don’t know if Wockhardt has shown interests or even if Tata Sons has pitched in. We have worked with Tata Sons in the past. We will be delighted if they are interested to take part in this. Also, IIL could work.”
So even though Moderna's vaccine has been approved by the US, UK and France and is being used in inoculation drives around the world, it is still important that the vaccine is tested in India. This is because not everyone will respond to a vaccine in the same way and that applies to people from the same race and even more so for people from different races. Health authorities need country-specific data to give their approvals and ensure the vaccine will not have any adverse effects on their people.
The bridge trial, as it is called, gives a country access to a vaccine that otherwise would've taken a long time to reach them. This is an important aspect especially in a crisis situation like COVID-19.
This is also the reason Russia's COVID-19 vaccine Sputnik V needs to complete a Phase 3 trial and have partnered up with Hyderabad's pharma company Dr Reddy's and why AstraZeneca tied up with Serum Institute of India to conduct the Oxford vaccine trials and produce it in India. Johnson & Johnson have also tied up Biological E to conduct a trial in India.
The other reason, according to a Reuters report, is that India has made it mandatory for any vaccine maker to conduct a clinical trial in the country before it will get a chance to be approved.
According to the ET report, "exploratory talks have started between Tata Medical & Diagnostics and Moderna and concrete plans will be finalised once government approvals for private sector participation come in".
Right now, India has only approved two vaccines - Bharat Biotech's Covaxin and Serum Institute of India's Covishield - for emergency use. According to NITI Aayog Member Dr VK Paul said that India has six vaccine clinical trials that are currently going on in the country.
About Moderna vaccine
The Moderna vaccine is based on mRNA technology and evidence from its clinical trials for its COVID-19 vaccine shows that it was 94 percent effective at preventing lab-confirmed COVID-19 in people who were given two doses and had no history of the infection. Moderna's vaccine candidate 'mRNA-1273' is believed to offer protection against the virus for 'several months' according to World Health Organisation (WHO) but according to the company's CEO Stephane Bancel, immunity against the vaccine can last for a couple of years.
The vaccine is given in two doses 28 days apart and can be extended to 42 days. It has shown to be effective around 14 days after one receives the first dose. The vaccine needs to be kept frozen between -25°C and -15°C, which is similar to a normal freezer if it’s not being used immediately. Each vial contains enough doses to vaccinate 10 people. According to a Time report, the vaccines needs to be thawed before it is used and once thawed, the unopened vial needs to be used within 30 days. Once a vial is punctured, it needs to be used within six hours.
The vaccine was not tested in pregnant or breastfeeding women and more studies need to be conducted to know if it is safe for them. The US's Centre for Disease Control (CDC) said it is a woman's personal choice. The vaccine is also not supposed to be given to children under the age of 18 years as those studies are needed to be conducted as well.
According to the clinical trial data, WHO says the vaccine is safe and effective in people with known medical conditions hypertension, diabetes, asthma, pulmonary, liver or kidney disease, as well as chronic infections that are stable and controlled.
The most common side effects, according to the CDC, from getting the vaccine are pain in the arm you got the shot along with swelling and redness. Other effects throughout the body are chills, tiredness and headache.
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