The United States (US) has given the green signal to its second Covid-19 vaccine, from biotech company Moderna. The first off-the-block was Pfizer-BioNTech’s vaccine that received an Emergency Use Authorisation (EUA) about a week ago.
In giving the EUA to Moderna for the prevention of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the Food and Drug Administration (FDA) said the vaccine would be distributed in the US to those 18 years of age and above.
FDA Commissioner Stephen M Hahn reiterated, the two Covid-19 vaccines had been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. “These standards and our review process, which are the same we have used in reviewing the first Covid-19 vaccine and intend to use for any other Covid-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff,” he said.
Stéphane Bancel, Moderna’s Chief Executive Officer said, they were able to create and manufacture their vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.
Unike, Pfizer, that has a presence in India and has applied for an EUA, Moderna does not have a base or alliance in India to distribute here at present. Moderna’s vaccines pose a lesser storage and distribution challenge, with requirements of – (minus) 20 degrees Celsius, as compared to Pfizer that needs – (minus) 70 degrees C.
Interestingly, American music icon Dolly Parton is invested in the company since April.
Parton told BBC's "The One Show" , "I just felt so proud to have been part of that little seed money that will hopefully grow into something great and help to heal this world. I'm a very proud girl today to know I had anything at all to do with something that's going to help us through this crazy pandemic."
India’s Azim Premji, founder-Chairman of Wipro is also reportedly invested in the firm through his private investment arm.
m-RNA vaccines
The Moderna vaccine, like the Pfizer-BioNTech one, also contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein, the FDA explained. “After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”
This vaccine too is given in two doses, one month apart. And it was seen to be 94 percent effective during the trials.
Side-effects
The FDA noted, that commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. More people experienced these side effects after the second dose, the FDA note said calling for vaccination providers and recipients to expect some side effects after either dose, but even more so after the second dose.
Approximately 20 million doses will be delivered to the US government by end December 2020, Moderna. The company expected to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the US.