What happens when a Covaxin vial is opened but no patient is present? Bharat Biotech explains what Covaxin is and how it works.
Covaxin has been given to 110.6 million people in India as of October 2021. The World Health Organization (WHO) validated the vaccine for emergency use on November 3, 2021.
The vaccine is 64 per cent (95 per cent CI, 29–82 per cent) effective against asymptomatic cases, 78 per cent (65–86 per cent) effective against the symptomatic disease, 93 per cent (57–100 per cent) effective against severe illness, and 65 per cent (33–83 per cent) effective against the Delta variant, according to a phase 3 clinical trial with 25,798 participants.
Covaxin uses a more traditional method, similar to the inactivated polio vaccine, as an inactivated vaccine. Initially, India’s National Institute of Virology obtained a sample of SARS-CoV-2 and employed Vero cells to grow vast numbers of the virus. The viruses are then immersed in beta-propiolactone, which deactivates them by attaching to their genes while keeping the rest of the virus intact. The inactivated viruses are then combined with Alhydroxiquim-II, an aluminium-based adjuvant.
Bharat Biotech’s in-house Vero cell manufacturing technology, which has a capacity of 300 million doses, is used to make the vaccine candidate. Covaxin is being manufactured in a second unit at the Genome Valley site in Hyderabad. In conjunction with the Government of Odisha, the company is building a new facility in Bhubaneswar’s Odisha Biotech Park to start producing Covaxin by June 2022. Aside from that, they’re looking at global collaborations for Covaxin production.
Ocugen and Bharat Biotech formed cooperation in December 2020 to co-develop and commercialise Covaxin in the United States; the partnership was expanded to include Canada in June 2021. Precisa Med and Bharat Biotech signed an agreement in January 2021 to supply Covaxin to Brazil.
Haffkine Bio-Pharmaceutical Corporation Limited of the Haffkine Institute signed a memorandum of understanding (MoU) with Bharat Biotech in May 2021, announcing that they will begin producing Covaxin after receiving support from the Maharashtra state government and approval from the Indian government. In contrast, Indian Immunologicals Limited (IIL) has signed a commercial agreement with Bharat Biotech to produce the drug substance, a critical vaccine component.
The pharma giant explained its 28-day open vial policy by saying that healthcare professionals don’t have to worry about opening a vial and wasting it. Bharat Biotech explained that if patients are unavailable, they may store the unsealed vial at 2 to 8°C and use it the next day or preserve it for up to 28 days. This means that an open Covaxin vial can be utilised for up to 28 days after opening and will not be thrown away if no patients are available right away.
Extension of the Shelf-Life of Covaxin
Covaxin, a product of Bharat Biotech, was also approved for usage under the Drugs Controller General of India’s 28-day multi-dose vial policy and the WHO Emergency Use Listing on Monday.
Covaxin’s shelf life was recently extended by the Central Drugs Standard Control Organization (CDSCO) to up to 12 months from the date of production. According to Bharat Biotech, this permission of shelf-life extension was predicated on the availability of additional stability data submitted to CDSCO.
With the shelf-life extension, hospitals can now use stock about to expire and avoid further vaccine waste.
The company has said that it is committed to environmental protection, and it claims that its strategy of 20-dose vials saves procurement agencies money by decreasing cold chain logistics and management. Bharat Biotech stated, “Thereby decreasing the carbon footprint, costs associated with open vial wastage and cold chain distribution, cold chain storage, biomedical wastes, and so on.”
“Most significantly, we believe in being ecologically friendly by minimising the amount of packing material and single-use plastics used in vaccine manufacturing, storage, distribution, and disposal,” the vaccine manufacturer explained.
Covaxin’s Phase 2 and 3 studies for children aged 2 to 18 years have been completed by Bharat Biotech. The information has been sent to the Central Drugs Standard Control Organization (CDSCO), pending final approval. Children will have access to the vaccine if it is approved.
edited and proofread by nikita sharma