The All India Institute of Medical Sciences (AIIMS) in Delhi is likely to submit a proposal to its ethics committee to start the final-stage trials of Bharat Biotech-ICMR’s Covid-19 vaccine candidate, COVAXIN. Meanwhile, American pharmaceutical company, Novavax Inc, has laid out specific diversity targets for its large-scale Covid-19 vaccine study which is expected to begin in the US and Mexico next month. Also, the UK drug regulator has started accelerating reviews of Covid-19 vaccines under development from Pfizer Inc. and AstraZeneca.
Here are the latest updates on coronavirus vaccine:
NOVAVAX OUTLINES SPECIFIC MINORITY TARGETS FOR US COVID-19 VACCINE TRIAL
Novavax Inc has outlined specific diversity targets for its large-scale novel coronavirus vaccine study which is expected to begin in the US and Mexico next month. On Friday, the company said that it plans to include 10 per cent to 20 per cent Latinos, 15 per cent Black or African Americans and 1 per cent to 2 per cent Native Americans in its study, according to a report in Reuters. The company is already testing its vaccine in a Phase III trial in Britain.
The report further said that diversity has become an important consideration in the testing of vaccines to prevent Covid-19 infection because of the outsize toll the pandemic has taken on minorities. Blacks have been three times as likely to contract Covid-19 as white Americans and twice as likely to die from the disease, it said.
Pfizer Inc and Moderna Inc has already begun their Phase III Covid vaccine trials in late July. Pfizer expanded its trial to 44,000 subjects, in part to increase minority enrollment. Moderna slowed its trial to increase minority participation, which last week completed enrollment with Black Americans making up 10 per cent of the study population, the Reuters report said.Novavax has also enrolled over 5,500 participants to date in the United Kingdom (UK) trial, which it has expanded to 15,000 volunteers. "The company expects this trial to be fully enrolled by the end of November, and dependent on the overall Covid-19 attack rate, interim data in this event-driven trial are expected as soon as early first quarter 2021. These data are expected to serve as the basis for global licensure," a press release read.
AIIMS DELHI TO SUBMIT PROPOSAL FOR PHASE 3 TRIAL OF COVAXIN
The All India Institute of Medical Sciences (AIIMS) in Delhi is likely to submit a proposal to its ethics committee to start the Phase 3 trials of Bharat Biotech-ICMR’s Covid-19 vaccine candidate, COVAXIN.
Last week, Bharat Biotech got an approval from the drugs controller general of India (DGCI) to conduct phase 3 clinical trials of its vaccine candidate named Covaxin in 26,000 participants in over 25 centres across India. AIIMS Delhi is one of the sites which has been selected for carrying out last-stage trials across India, said a report in the Hindustan Times.
The report quoted Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi, as saying, "The proposal is being prepared for the phase 3 trials, and within a couple of days we will be submitting it to the institute ethics committee for approval."
Covaxin, India's indigenous coronavirus vaccine by Bharat Biotech, is being developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). It received drug regulator DCGI's approval for Phase I and II human clinical trials which commenced across India from July 2020. Bharat Biotech also received the approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
"US SIGNS UP PHARMACY CHAINS AS COVID-19 VACCINATION CENTRES"
According to a Wall Street Journal report on Friday, several US retail pharmacy chains have agreed to serve as Covid-19 vaccination sites under a federal government plan. The government would provide the vaccines to the pharmacies free of charge to help expand and accelerate the public’s access to vaccines as supplies increase, Reuters quoted the WSJ report as saying.
The pharmacies would be involved in the second phase of the planned vaccine rollout in the US, the report said, with the first phase targeted at healthcare workers and others at high risk of infection. The companies involved in the plan and the CDC did not immediately respond to requests for comment.
UK ACCELERATES REVIEWS OF PFIZER, ASTRAZENECA-OXFORD VACCINES
The United Kingdom’s drug regulator has started accelerating reviews of Covid-19 vaccines under development from Pfizer Inc. and AstraZeneca Plc, as Britain gets ready to approve the first successful shot as soon as possible, Bloomberg reported.
According to the report, the UK Medicines and Healthcare Products Regulatory Agency has started a so-called rolling review of the Pfizer vaccine in recent weeks. The procedure hasn’t been announced publicly.
The health agency is also conducting an expedited review of Covishield -- Astra’s vaccine, which the company is co-developing with the University of Oxford -- a spokesman for Astra was quoted as saying.