Serum Stops COVID-19 Vaccine Trial In India; Russia Rolls Out Vaccine For Public
Serum Institute of India (SII) paused the trials of Covishield, Oxford University-AstraZeneca’s COVID-19 vaccine after a notice issued the Drug Controller General of India (DCGI).
Meanwhile, Russia was set to make Sputnik V, the ‘first registered COVID-19 vaccine’ available for public distribution on September 7.
Read on to find out more about the COVID-19 vaccines…
Serum Institute Under DGCI’s Sharp Watch!
On Tuesday, AstraZeneca said that it was pausing the clinical trials in the UK after a person participating in the trial developed an ‘unexplained illness’. The company said, “The move was intended to give researchers time to examine safety data while maintaining the integrity of the trials.”
On Wednesday, the DGCI issued a show-cause notice to the Pune-based vaccine manufacturer asking why the company hadn’t informed the central drug regulator about the problems faced by AstraZeneca during trials in the UK.
The notice stated that one of the conditions to start the trial in India was that “the clinical data generated in this trial shall be considered along with the data from Oxford University clinical trial”. It further added, “why the permission granted to you shall not be suspended till patient safety is established.”
The SII on Wednesday said that it had not faced any issues in its trials so far and that it was continuing with its trials here.
The Russian COVID-19 Vaccine Can Come To India!
The Russian Gam-COVID-Vac (Sputnik V) launched on August 11 is developed by the Russian Gamaleya National Research Center of Epidemiology and Microbiology under Russia’s Ministry of Health of Russia. The vaccine’s phase I and II trials have been completed but phase III is still pending.
The head of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev said that clinical trials for phase III will commence in the United Arab Emirates (UAE), the Philippines, India, and Brazil in September, and the study will include 40,000 participants.
Denis Logunov, director for research at Gamaleya Institute and the associate member of the Russian Academy of Sciences said, “[The vaccine] examination is to begin within days… There is a certain procedure of authorizing a batch for civilian use. It must pass the quality check of the medical watchdog Roszdravnadzor,”
He added, “….between 10-13 September, we are to obtain permission to release a batch of the vaccine for civilian use. Respectively, from that moment on the population will begin to be vaccinated.”
The Russian Health Ministry will supervise the distribution of the vaccine. The Russian Health Minister Mikhail Murashko said individuals falling under the high-risk category for COVID-19 such as medical professionals, teachers among others will be vaccinated first.
The Russian government is in talks with the Indian government to start the localized manufacturing of the vaccine.
Dmitriev told CNBT TV18 that if all goes well, Russia could start delivering the COVID-19 vaccine from November this year, with some 30 crore doses produced in India.
The catch here is that the World Health Organization hasn’t approved the vaccine for human use yet.
China’s First COVID-19 Fighting Nasal Spray!
The Chinese Government has given a go-ahead for clinical trials first nasal spray vaccine to fight the COVID-19 virus.
The trials will likely start in November this year.
As per Global Times reports, it is the only vaccine of its type approved by China’s National Medical Products Administration.
The vaccine is a collaborative venture between Hong Kong and China. It has researchers from the University of Hong Kong, Xiamen University, and Beijing Wantai Biological Pharmacy working on it.
The report also said that it is not yet clear whether the nasal spray vaccinations will develop a long-lasting immunity amongst humans than injected vaccines.