The company said in its statement, "It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety".
The Subject Expert Committee of Drugs Controller General of India (DCGI) recommended that permission should be granted to the vaccine maker to conduct the trials. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.
As reported by The Irish Independent, managing director of Pfizer's Ireland business Paul Reid (not to be confused with HSE chief Paul Reid), has said there are strong indications that the company's experimental vaccine could be granted emergency approval at the end of next month.
Such temporary halts of drug and vaccine testing are relatively common: In research involving thousands of participants, some are likely to fall ill.
This initiative was meant to ensure access to Covid-19 vaccine which now has up to nine different candidates under the Global Alliance for Vaccine and Immunisation (GAVI).
Zydus Cadila is now conducting mid-stage trials of its own vaccine hopeful, while Serum Institute is making potential vaccines from AstraZeneca, Novavax and Codagenix Inc, as well as developing its own. If we finish the clinical trials in the next 2-3 months, even those may be approved by January-February. AstraZeneca is developing the vaccine in collaboration with researchers at Oxford University.
AstraZeneca Plc, the United Kingdom drugmaker developing a coronavirus vaccine with the University of Oxford, has been cleared by USA regulators to restart a trial halted in the country for more than a month on concerns about a volunteer who became ill, according to a person familiar with the decision.
Recto said appointing the vaccine czar this early would also jumpstart the setting up of a "supply-to-syringe cold chain" as the vaccines have to be moved and stored in freezing temperatures in a tropical country that lacks infrastructure for it.