The global death rate due to the COVID-19 pandemic is witnessing a rise, hinting towards urgency for the vaccine.
‘The Show cause’ notice
Serum Institute received a ‘show cause’ notice from India’s drug regulator after AstraZeneca announced the halt of COVID-19 vaccine trials in the UK amid safety concerns.
The Halt of AstraZeneca COVID-19 Vaccine
On Sept 8, 2020, the United Kingdom suspended the clinical trials of one of the Oxford-AstraZeneca’s COVID 19 vaccines. The event occurred a day after the India-based vaccine maker received a show-cause notice from the Drug Controller’s General of India(DGCI).
Serum Institute of India stated on Sept 10, 2020, that halting the trial of the Oxford University Astrazeneca COVID-19 vaccine in India will be due until the British- Swedish drug maker restarts the trial. “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI’s instructions.” Serum Institute of India affirmed.
The Unexplained Illness
The reason behind the halt of clinical trials of one of the Oxford- Astrazeneca’s COVID-19 vaccine in the United Kingdom was after a patient developed an obscure illness. Following this incident, several officials questioned the patient safety. According to the provided information, the patient suffered ‘Transverse myelitis’ (An inflammation of the spinal cord).
Nevertheless, it is still to be confirmed that the illness may or may not have anything to do with the vaccine. However, the officials thought it is the best sort of cautious approach to quickly stop and see if there’s any other evidence to be concerned about.
Further Plans of the Serum Institute
Serum Institute of India has tied-up with AstraZeneca, to manufacture the COVID-19 vaccine for low and middle-income countries. The vaccine was already under phase II/III trials in the UK, South Africa, and Brazil; the participants were being administered two doses nearly a month apart. This made Oxford’s AstraZeneca on the top list amongst the global frontrunners for the COVID-19 vaccine. Halting the clinical trials could postpone the vaccine development process as Serum Institute is the pacesetter producing the COVID 19 vaccine.
Distribution of the COVID-19 vaccine
In the meanwhile, the Serum Institute has promised to provide 400 million doses to low and middle economic nations by 2020 and 1 billion doses in total. The Institute aims to produce over 6 crore doses per month of its vaccine candidate, which will rise to 10 crores per month by April 2021. For now, the drug regulator mentioned that the clinical tests have been delayed across countries namely the USA, UK, Brazil, and South Africa.
On the other hand, the cases have been surging developing urgency for the vaccine. India counts as the second most affected country after the US in terms of COVID-19. India registered a record single-day spike of 95,735 COVID-19 cases and 1,172 fatalities in one day.
The countries are expected to be patient as the Serum Institute is overtaking the disruption and functioning to deliver the COVID -19 vaccine as soon as possible.
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