Coronavirus vaccine: Zydus Cadila to complete Phase II in 3 months; Oxford candidate safe for 'low immunity' patients

As the race to find a coronavirus vaccine speeds up, all bets have been placed. Most experts as well as pharmaceutical companies believe that a coronavirus vaccine candidate will be ready only by mid-2021. However, it must be pointed out that formulating a COVID vaccine is only one of the many hurdles that needs to be overcome. The World Health Organisation (WHO) and its alliance partners including the vaccine alliance GAVI has said that the goal is to create 2 billion doses of the coronavirus vaccine by 2021. The organisation has assured that there would be enough doses to go around, initially to protect highest-risk groups as well as group that would be otherwise unable to afford it, including in poor and developing countries. "WHO is working on fast-tracking the process by aligning closely with vaccine developers, explaining evaluation criteria and harmonising regulatory requirements for clinical trials," said Chief Scientist Soumya Swaminathan.

Here are the latest developments from India and from across the world:

INDIA

Zydus Cadila: The pharmaceutical company has received approval from the DCGI to conduct human trials for the coronavirus vaccine it has named ZyCoV-D. The trials will begin this month with 1,000 volunteers across multiple cities. "We are following the adaptive clinical trial protocol (phase I followed by phase II without much gap in between) which, in a pandemic or emergency area, is permitted by regulators across the world. We will take about three months to complete the Phase I and II clinical trials, after which we will approach the DCGI for their consideration," said Zydus Cadila Chairman Pankaj R Patel in an interview to The Indian Express.

Also read: Coronavirus vaccine news update: Serum Institute to give 50% of doses to India; Moderna shows 'very promising results'

Premas Biotech:  The Gurugram-based Biotech company that has developed a triple antigen virus-like particle (VLP) vaccine candidate has said that it has moved to animal trials phase. "The four-week placebo-controlled, blinded and randomised tests to be conducted in mice, will seek to evaluate safety in the rodent model and examine immune response by dose titration," the company has said. Currently Premas is the only Indian company to explore a triple antigen COVID vaccine candidate.

Serum Institute of India: SII that is producing around four vaccine candidates including the Oxford University-AstraZeneca coronavirus candidate has said that it is expected to launch a candidate by the end of six months. In an interview with NPR, Adar Poonawalla has sad that they have jumpstarted the production of the four corona vaccine candidate even when their technology has not been proven. He also said that of all that he produces at SII, 50 per cent would be reserved for India and the rest would be given to other countries.

GLOBAL

Europe: The British government has decided not to join a European Union coronavirus vaccine scheme because of concerns there could be costly delays in securing the vaccines, The Telegraph reported on Thursday, citing sources. The European Commission is expected to be notified on Friday, the report said.

Also read: Coronavirus vaccine news update: Bharat Biotech, Zydus Cadila set for trials; SII expects nod in 6 months

Oxford University vaccine: Oxford University that is conducting trials of its ChAdOx1 vaccine has said that their vaccine is safe even for people with low immunity. "We have removed some of the adenovirus genes so that when we use it as a vaccine, the adenovirus can't spread through the body. That makes it very safe, even in people with a weak immune system. But because it is still a live virus, it is good at inducing a strong immune response after vaccination," said Professor Sarah Gilbert, Nuffield Department of Medicine, Oxford University. The vaccine is undergoing trials, involving 5,000 volunteers, in Brazil.

Moderna: The pharmaceutical company has concluded the participant enrolment for its phase two of trials. Moderna has, meanwhile, signed an agreement with Spain's Laboratorios Farmaceuticos Rovi SA to scale up production and manufacturing of its coronavirus vaccine. ROVI will procure a new production line and equipment for vial filling and packaging, automatic visual inspection and labeling, and hire more staff to support the production of millions of doses of Moderna's vaccine candidate, the companies said.

CORONAVIRUS DRUG

Gilead: The company said that it is starting early-stage study of its antiviral Remdesivir that can be inhaled. The drug would be for use outside of hospitals. Gilead said it would enrol around 60 healthy Americans between 18-45 years of age for the trials.

Pankajakasthuri Herbals: The Thiruvananthapuram-based company has said that interim clinical trial results of its ZingiVir-H have shown that the drug is effective in treating COVID-19 patients.  The product is a herbo-mineral drug made of a blend of seven ingredients. The company said of 42 patients, 22 were treated with ZingiVir-H tablets and 20 with a placebo. It was found that all the 22 patients treated with ZingiVir-H were discharged on the fourth day after real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) tests.

Fujifilm's Avigan: A clinical trial of Fujifilm Holdings Avigan drug has yielded inconclusive results, Japanese researchers said on Friday. Although patients given the drug early in the trial showed more improvement than those who got delayed doses, the results did not reach statistical significance, Fujita Health University researcher Yohei Doi said.

Also read: Coronavirus pandemic: Pankajakasthuri Herbals claims promising trial results of drug