The pre-prints or preliminary reports of research work related to Covaxin, which are yet to be peer-reviewed are already posted on pre-print servers like bioRxiv, medRxiv and Research Square
Hyderabad-based Bharat Biotech has said that peer-reviewed international journals will soon come out with scientific publications based on the product development and clinical trial data of its COVID-19 vaccine Covaxin. The pre-prints or preliminary reports of the work that are yet to be peer-reviewed are already posted on pre-print servers like bioRxiv, medRxiv and Research Square.
"The research thus far has generated five publications, which have been submitted to international peer-reviewed journals, four of which have been accepted and will be published soon. The publication of phase II trial data is undergoing the peer review process", the company said.
The pre-print on preclinical product development posted on bioriv.org highlights the safety aspects through claims that the vaccine generated significantly high antigen-binding and neutralising antibody titers, at both concentrations in all three species being studied, with excellent safety profiles. It was jointly authored by researchers associated with Bharat Biotech and its research partner Indian Council of Medical Research (ICMR).
Another paper, the pre-print of which is available on Research Square, says the protection of the hamsters after administering the vaccine was evident by the rapid clearance of the virus from lower respiratory tract, reduced virus load in upper respiratory tract, absence of lung pathology and robust humoral immune response. It said it confirms the immunogenic potential of the vaccine. The immunogenecity of the vaccine was also claimed in a paper that talks about the results on rhesus macaques.
A paper based on Phase I safety and immunogenecity human clinical trial, the pre-print made available on medRxiv the vaccine induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. The pre-print of Phase II trials, also available on medRxiv said in the phase 2 trial, BBV152 led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses. It also points out that the vaccine produced high levels of neutralising antibodies that remained elevated in all participants three months after the second vaccination.
On January 12, Bharat Biotech said that Brazilian government is keen to procure Covaxin for public supplies. Precisa Medicamentos, privately held Brazilian pharma firm has also signed an agreement for supplies of Covaxin. The supplies to the private market would be based upon receipt of market authorization from ANVISA, the Brazilian regulatory authority.