Indian vaccine makers are in no hurry to tie up with US biotech major Moderna to bring its mRNA vaccine candidate to India.
Most players that Business Standard spoke to said they would be concentrating on their own vaccine candidates or the current tie-ups that they have.
Pune’s Serum Institute, which has tied up with AstraZeneca-University of Oxford for the AZD-1222 candidate, said that it already had a better m-RNA candidate.
Two other vaccine players said they would rather watch keenly how the Moderna vaccine develops after it goes to phase 3, and are in no rush to tie up now. Hyderabad-based Indian Immunologicals (IIL) said it might consider a collaboration if the technology was suitable for its plant.
Serum, in fact, is gearing up to start the production of the Oxford-AstraZeneca
vaccine next month and aims to start the India trials. The trials are now in phase 3. If things go according to plans, Serum expects the vaccine to be ready for market by December.
Apart from Moderna, which published a report on the outcome of the phase 1 trial of its vaccine candidate m-RNA 1273 in The New England Journal of Medicine (NEJM), AstraZenca-University of Oxford is expected to publish details of its phase 1 trials in medical journal The Lancet by Monday. The candidate named AZD-1222 is using a weakened version of a common cold virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein.
Moderna’s mRNA 1273, on the other hand, uses RNA — a chemical messenger that contains instructions for making proteins. When this is injected into humans, the vaccine tells human cells to make the proteins that mimic the outer surface of the coronavirus.
The body then recognises this as foreign agent and initiates an immune response against it. It would go into phase 3 clinical trials later this month.
Indian players are also gearing up for the finishing line. Two candidates are already in human trials now — Bharat Biotech and Zydus Cadila’s vaccine candidates.
As for forging any collaboration with Moderna, a Serum spokesperson said: “Neither have we approached Moderna, nor have they approached us. We have a better mRNA candidate that we will be partnering with and will announce once it is done.”
Two more Indian vaccine players indicated that they had concerns about the protocols followed in Moderna vaccine trials.
“First, there was no placebo arm. Second, the participants were not screened for SARS-CoV-2 infection by serology or polymerase chain reaction before enrollment for the trials. If someone is asymptomatic and Covid positive, his body would already have some antibodies,” said a chief of a leading Indian biotech firm.
Another firm said while the publised data in NEJM shows Moderna’s candidate is relatively safe, but the efficacy bit is not clear. Another firm felt that the dosage of the Moderna vaccine is quite high.
Meanwhile, IIL, which is working on a live virus vaccine candidate, is open to collaboration. K Anand Kumar, MD of IIL, said: “We wouldn’t mind considering using our facilities for fill finish of the vaccine.”
“Oxford vaccines will be made and packaged in India. We are spending more than $100 million for this facility,” Adar Poonawalla, chief executive, SII, had told Business Standard.
Poonawalla said until the trials were completed successfully for safety and efficacy, vaccines would not be distributed either in India or anywhere else in the world.