As of 16th July 2020, the deadly coronavirus (SARS-CoV-2) has infected more than 13 million people and has claimed close to 6 lakhs life worldwide. This rapid spread has resulted in numerous pharma companies working around the clock to hunt for a vaccine against COVID-19. Amidst the news of deaths and rampant infection, encouraging news emerged on 14th July 2020. The interim analysis published in the NEJM (The New England Journal of Medicine), described the development of immune response in Phase 1 clinical trial patients for a candidate vaccine, which was developed by Moderna, an American biotech company.
Moderna’s COVID-19 Vaccine:
Moderna, along with the US NIH (National Institute of Health), began working on the mRNA-1273 vaccine candidate even before cases were reported outside of China in January. Since then, this vaccine has entered clinical trials, received huge fundings, and has been fast-tracked by the FDA (US Food and Drug Administration).
Vaccine Timeline and Milestones:
11th January 2020 – The genetic sequence of SARS-CoV-2 was shared by Chinese authorities.
13th January 2020 – The sequence for mRNA-1273 was finalized.
7th February 2020 – Within 25 days, the first clinical batch of mRNA-1273 was completed.
24th February 2020 – The clinical batch the vaccine was sent to the NIH for Phase 1 clinical study.
4th March 2020 – The FDA approved the use of the vaccine for clinical trials.
16th March 2020 – The vaccine was administered to the first participant in the Phase 1 study.
27th April 2020 – The vaccine was submitted to the FDA for Phase 2 study.
12th May 2020 – Moderna received FDA fast-track designation for its vaccine.
18th May 2020 – A positive interim data for the Phase 1 study was announced.
29th May 2020 – The vaccine was administered to the first participant in the Phase 2 study.
14th July 2020 – Interim results of Phase 1 study was published in the NEJM.
Phase 1 Clinical Trials:
In phase 1, 45 healthy adults between the age groups 18 and 55 years received two mRNA-1273 vaccinations, 28 days apart. Out of the 45 adults, 15 were administered 25 μg, 15 received 100 μg, and the remaining 15 got 250 μg of the vaccine. This phase aims to determine an effective dose.
Phase 1 Result – The virus-killing antibodies in participants who received two doses were high as compared to the average levels seen in recovered COVID-19 patients. More than half of the participants experienced mild side effects, such as headaches, tiredness, chills, muscle pain, and pain at the injection site, but no one showed severe side effects that needed immediate hospitalization. The side effects commonly occurred in participants who received two high doses of the vaccine. As side effects were more as the dosage increased, the 100 μg dose was chosen for further studies to minimize adverse reactions, and the 250 μg dose will not be administered in phase 2.
Phase 2 Clinical Trials:
Phase 2 trials will be conducted on 600 healthy volunteers (adults between 18 and 55 years, and above 55 years). The participant will receive Placebo, 50 μg, or 100 μg doses twice. They will then be monitored for 12 months. This phase is done to determine the effectiveness of the vaccine in a larger group.
Phase 3 Clinical Trials:
The company expects to start the third phase by 27th July 2020. The third phase will be conducted on 30,000 volunteers, to confirm the efficacy and identify the side effects of the vaccine.
Another Promising Vaccine:
Another candidate vaccine (ChAdOx1 nCoV-19) developed by Oxford University, induces an immune response by delivering a SARS-CoV-2 protein. The vaccine is in phase 3 trials, and they are yet to announce the results of phase 1.
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