India is in conversation with the US-based biotech company, Moderna who recently announced their progress in the trials of the coronavirus vaccine as their candidate of the trials showed 95% effectivity on 16th November.
Along with Moderna, India is coordinating for the progress of the coronavirus vaccines with the Serum Institute, Bharat Biotech, Pfizer and Zydus Cadila. They are also considering safety, immunogenicity and regular approvals in the trials of the vaccines. The New Drugs and Cosmetics Rules of 2019 states that any new tested vaccines or drug which also have regulatory approvals has to seek phase 2 and 3 of the clinical studies.
However, the Central Drugs Standard Control Organisation in the New Drugs and Cosmetics Rule of 2019 can alter the regulatory requirements of giving clinical data and pharmaceutical data of the candidate in the Indian population in emergency situations.
If they allow the emergency use of the vaccines, there will be rationed supply by the end of the year. With every patient requiring 2 doses in a few weeks, Moderna is sure of developing 20 million doses by the end of 2020, while their competitors- Biotech and Pfizer managing 50 million doses.
The CEO of Moderna, Stephane Bancel said that they have been pursuing the development of the virus since January with the intent of protecting people from all around the world from the coronavirus.
The Independent National Institutes of Health assigned the Data Safety Monitoring Board in charge of the study of phase 3, mRNA-1273, said Moderna. It was found that the recovery of the candidate against coronavirus was progressing and achieved 95% effectivity level.
Soon after Biotech and Pfizer announced a 90% success rate in treating COVID- 19, Moderna gave the statement of 95% effectivity of their vaccine. Moderna’s president, Hoge believed that they have achieved a huge milestone, it is also reassuring that many companies have reached a successful level in developing the vaccine. People from all around the world would require vaccines, Moderna alone would not be able to solve the problem.
In the US, the corona cases have reached over 11 million cases while 1.3 million people have lost their lives to coronavirus. Even India had recorded over 8 million coronavirus cases and 1,28,121 people have died due to the virus.
A major challenge would be about distributing the vaccines which are supposed to be kept in low temperatures. Moderna stated that their vaccine can last for 30 days when kept in cold temperature. While the Pfizer has to stock the vaccines in the ultra-cold temperatures for a long duration.
Moderna also said that Phase 3 of the vaccine trials indicated the first success that the Moderna vaccine can prevent being infected from coronavirus and also other severe illnesses.
On 16th November, the Head of World Health Organisation said that a vaccine alone is not sufficient to prevent the spread of coronavirus pandemic. It can at most be used as one of the tools of combatting the virus but it alone cannot replace them. “A vaccine on its own will not end the pandemic”, said Tedros Adhanom Ghebreyesus, Director-General.
The vaccine can help in treating the patients, however, it would leave a lot of virus in the room. After treatment, it is important for people to be monitored, tested and cared for.
He also said that in the earlier stage, the vaccine will be kept for the health workers, people who are at risk of virus and the old people. It would help to reduce the deaths and control the infection from spreading.
The results of the clinical trials made Moderna submit for the Emergency Use Authorisation with the Food and Drug Administration of the United States in a few weeks time. They are also expecting the authorisation based on the safety analysis and the trial data in the next 2 months.
