New Delhi: Hyderabad-based Bharat Biotech has sought approval from the Drug Controller General of India (DCGI) to conduct a phase-3 study of its intra-nasal COVID-19 vaccine as a booster dose on participants vaccinated with Covishield or Covaxin. PTI reported.
It comes as several wealthy countries are rushing to deploy COVID-19 booster shots to enhance people’s defenses against the Omicron coronavirus variant.
In August, Bharat Biotech received approval to conduct phase 2 trials of its intra-nasal vaccine BBV154. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.
PTI reported that in the first phase of the trial, the vaccine given to healthy volunteers was well tolerated and no serious adverse events were found.
Pre-clinical toxicity studies have shown that the vaccine is safe, immunosuppressive and well-tolerated. The vaccine was able to elicit high levels of neutralizing antibodies in animal studies, it said.
Open vials of Covaxin can be stored for up to 28 days
Bharat Biotech said the opened vials of Covaxin can be stored at 2-8 degrees Celsius for up to 28 days.
Bharat Biotech, while highlighting its 28-day open vial policy, said, “There is no need for the health workers to worry about opening the vial and wasting it. If patients are not available, they may simply store the opened vial at 2 to 8 °C, and use it the next day, or store it for up to 28 days.,
28 Days Open Vial Policy: Health workers need not worry about opening the vial and its wastage. If patients are not available, they can simply store the opened vial at 2 to 8°C, and use it the next day or store it for up to 28 days: Bharat Biotech pic.twitter.com/1whoMuv3B1
— ANI (@ANI) December 20, 2021
The firm said the extension of Covaxin’s shelf life to 12 months from the date of manufacture was recently approved by the Central Drugs Standard Control Organization. It added that Covaxin was also approved for use by the WHO under its 28-day multiple-dose vial policy.
India not yet considering booster dose
According to a Reuters report last month, India is not considering authorizing booster doses because many people in the country have been naturally infected and the government thinks two vaccine doses are enough protection for the time being. .
About 87 percent of India’s adult population, an estimated 939 million people, have been given at least one dose, with 54 percent receiving both. Vaccination has not yet started for people under the age of 18.
(with inputs from agencies)
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