India's drug regulator has granted emergency use approval for Zydus Cadila's COVID-19 vaccine, the world's first DNA shot against the coronavirus, in adults and children aged 12 years and above, repports REUTERS. The approval gives a boost to India's vaccination programme, which aims to inoculate all eligible adults by December, and will provide the first shot for those under 18, as the country still struggles to contain the virus spread in some states. Read: Zydus seeks nod for world’s first plasmid DNA Covid vaccine The vaccine, ZyCoV-D, uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to. Unlike most COVID-19 vaccines, which need two doses or even a single dose, ZyCoV-D is administered in three doses. The generic drugmaker, listed as Cadila Healthcare Ltd, aims to make 100 million to 120 million doses of ZyCoV-D annually and has already begun stockpiling the vaccine. Read: US to recommend COVID vaccine boosters at 8 months Zydus Cadila's vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorization in India after Bharat Biotech's Covaxin. The drugmaker said in July its COVID-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes. read more The regulatory nod makes ZyCoV-D the sixth vaccine authorized for use in the country where only about 9.18% of the entire population has been fully vaccinated so far, according to Johns Hopkins data. Read: Thailand to start trials of homegrown Covid-19 vaccine in September Zydus Cadila had also submitted data evaluating a two-dose regimen for the shot in July and plans to seek regulatory approval for the same. The firm had applied for the authorization of ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.

The Directorate General of Drug Administration (DGDA) has approved Chinese Covid-19 vaccine ‘CoronaVac’, manufactured by Sinovac Life Science Co Ltd, for emergency use in Bangladesh. The DGDA has given the approval following an application submitted by M/S Incepta Vaccine Limited on June 3, said a DGDA handout on Sunday. Read:WHO validates Sinovac COVID-19 vaccine for emergency use M/s Incepta Vaccine Limited is the local agent of the vaccine. The Chinese vaccine earlier got approval from the World Health Organization (WHO). It is applicable for people aged above 18. National Medicinal Products Administration (NMPA) of China approved the vaccine on February 9 and it was later approved for emergency use in 22 more countries, said the media release. Read:EU medicine regulator starts rolling review of Sinovac COVID-19 vaccine It is 5th vaccine that got approval for emergency use in Bangladesh. Health authorities will administer two doses of the vaccine to a person, and its second dose can be administered within two to four weeks after getting the first dose. Read: Sinovac: CoronaVac vaccine effective in children Earlier, five lakh China’s Sinopharm Covid-19 vaccine doses, donated by the Chinese government to Bangladesh, arrived in Dhaka on May 12.  

The World Health Organization (WHO) on Tuesday validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing. The vaccine is produced by the Beijing-based pharmaceutical company Sinovac. “The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” said Dr Mariangela Simao, WHO Assistant-Director General for Access to Health Products. “We urge manufacturers to participate in the COVAX Facility, share their knowhow and data and contribute to bringing the pandemic under control.” WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions. In the case of the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility. The Sinovac-CoronaVac product is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for low-resource settings. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. On the basis of available evidence, WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks. Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalization in 100% of the studied population. Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons. There is no reason to believe that the vaccine has a different safety profile in older and younger populations. WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries. READ: Panel suggests WHO should have more power to stop pandemics WHO emergency use listing The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks. The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan with a focus on low- and middle-income country needs. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies. As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability. READ: German minister laments choice of Syria for WHO board seat WHO has already listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Astra Zeneca EU, Janssen, Moderna and Sinopharm vaccines for emergency use.

Mexico approved the Oxford-AstraZeneca coronavirus vaccine for emergency use Monday, hoping to spur a halting vaccination effort that has only given about 44,000 shots since the third week of December, about 82% of the doses the country has received.