The recognized Covid-19 cases have surpassed 6.3 million globally and continue to grow. While the world is eagerly waiting for the coronavirus vaccine, research and clinical trials are going on at a fast pace to find a cure for the novel coronavirus. More than 100 vaccines are under development around the world. Many may never reach human trials, but several have rapidly reached a stage which generally takes years, and sometimes decades.
CNBC-TV18 reports Albert Bourla, chief executive officer of Pfizer saying, “If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can have a vaccine around the end of October .” Pfizer is currently in the clinical trial stage of vaccine development, with German firm BioNtech and waiting for regulator’s approval to begin a US trial soon.
Moderna’s Coronavirus vaccine enters phase 2 trial
On 29 May, US-based Moderna announced that the first participants in each age cohort had received an initial dose in the phase 2 study of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus. The phase 2 study is for evaluating the safety, reactogenicity, and immunogenicity of two doses of the vaccine given at an interval of 28 days. Moderna anticipates collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) in the Phase 3 study, beginning in July.
Phase 1 trial of Inovio’s Covid-19 vaccine to start in June
On 20 May, Inovio announced the publication of the preclinical study data for IN0-4800 (Covid-19 DNA vaccine) demonstrating robust neutralizing antibody and T cell immune responses against coronavirus in mice and guinea pigs. J Joseph Kim, president and chief executive officer of Inovio, said, “Inovio and our collaborators are working to advance INO-4800 to help fight the current pandemic. We are planning to utilize these preclinical results and our upcoming animal challenge data and safety and immune responses data from our phase 1 studies to support rapidly advancing this summer to large, randomized Phase 2 or 3 clinical trials.”
AstraZeneca to produce a billion doses
Britain’s AstraZeneca has gained international attention with its pursuit of a coronavirus vaccine and obtaining US government funding as it aims to provide a billion doses in the coming year. AstraZeneca’s manufacturing partner Oxford Biomedica has signed a deal with the company to offer multiple batches of the Covid-19 vaccine, now being tested on humans. Developed by researchers at the University of Oxford, the AZD1222 vaccine was licensed to AstraZeneca. AstraZeneca is in discussions with several governments and global partners to boost the production of the vaccine.
GSK to produce 1 billion doses of pandemic vaccine adjuvant in 2021
On 28 May, GSK confirmed its intention to manufacture 1 billion doses of its Covid-19 vaccine adjuvant system, in 2021. The aim is to support the development of multiple adjuvanted novel coronavirus vaccine candidates.
GSK’s pandemic adjuvant technology claims to make a considerable contribution to helping vaccines work against Covid-19. It can reduce the amount of vaccine protein required for each dose, effectively multiplying the vaccine doses produced.
Additionally, it claims to enhance the immune response to create long-lasting immunity against infections. The company is in talks with Governments and global institutions about funding for the production and supply of the adjuvant.
Clinical trials for existing drugs
Several drugs have received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of Covid-19 patients.
- In collaboration with Gilead Sciences, Swiss company Roche has announced the initiation of a global phase 3, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra, RoActemra, and antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe Covid-19 pneumonia.
- Glenmark Pharmaceuticals has announced a new randomized study to test the combined efficacy of the two antiviral drugs Favipiravir and Umifenovir, against Covid-19. Though the two antiviral drugs have a different mechanism of action, their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during the early stage of the disease.
- Sun Pharmaceutical has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate in Covid-19 patients. Nafamostat is approved in Japan for improving acute symptoms of pancreatitis and the treatment of Disseminated Intravascular Coagulation (DIC).
Status of the Covid-19 vaccine in India
In a recent interaction with IANS, health minister Harsh Vardhan threw some light on the vaccine development scenario. According to him, the Government of India, central ministries and autonomous institutes and agencies have been supporting vaccine companies in developing an efficacious vaccine against Covid-19.
According to Vardhan, more than 14 vaccine candidates are in different development stages currently, and more than four are at advanced stage preclinical trials. Around ten have got recommendations for funding support by the Department of Biotechnology. The CSIR has funded the Monoclonal antibody program through, National Centre for Cell Science, Pune in collaboration with IIT, Indore, and Bharat Biotech.
He adds, “Serum Institute of India is funded for a Phase 3 human clinical trial of a recombinant BCG vaccine candidate. Cadila Healthcare is funded for a DNA vaccine candidate, Bharat Biotech International, for a safe inactivated rabies vector platform, and Gennova Biopharma for an mRNA vaccine candidate. The National Institute of Immunology is developing a novel vaccine evaluation platform to support Covid-19 vaccine development in resource-limiting settings.”