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Hyderabad-based vaccine candidate start humans trials for covid-19

The fourth vaccine candidate of India, Biological E. Ltd.’s vaccine has begun the human trials for reckoning the efficiency it has to prevent the covid-19 virus. The results of the same are being expected by February 2021, the company said in a statement on Monday.

The drug maker had started its phase I and II after receiving due permissions from the Drugs Controller General of India. The vaccine candidate is getting formulated in alliance with the Texas, Houston’s Baylor College of Medicine and another US firm Dynavax Technologies Corp.

The human trials will be done in two doses in each participant with a duration of 28 days being maintained between every IM administration. A total of 360 volunteers have become a part of this research, ranging from 18-65 years.

“We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of COVID-19,” said Mahima Datla, Managing Director, Biological E. Limited.

Biological E. Ltd.’s vaccine comprises of an antigen, which is licensed from the BCM Ventures, Baylor College of Medicine’s unified commercialization group, and another progressed adjuvant called CpG 1018 that came from the Dynavax firm. An adjuvant is the entity holding pharmacological and immunological agents to enhance the immune reaction or response from a vaccine to the agent of choice.

The CEO of Dynavax, Ryan Spencer, spoke further about the potentials of the adjuvant to improve the vaccine’s capability and allow it to work with the smallest dose, thus enabling more people to get vaccinated.

The new phase of the vaccine will monitor and estimate the extent of safety and immunogenicity it offers at 3 dose levels, along with CpG 1018 and alum.

“The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine,” said Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development.

Another vaccine candidate of Hyderabad, COVAXIN, is being developed by Bharat BioTech. The candidate, in partnership with the Indian Council of Medical Research, announced the vaccine’s entrance into the phase 3 of clinical trials on Monday.

Though India is the second highest country with the most number of cases worldwide, after the US, there has been a decrease in the figure of daily infections post the peak of mid-September. Whether this is due to low testing or any other reasons hasn’t been established yet.

The world on the other hand, got a rope to cling on their hopes to for an efficient vaccine, after Moderna Inc, the US-based drug maker called its vaccine 94.5% effective in preventing the infection. The company’s experimental vaccine’s power was based on the interim data obtained from a late-stage of the trials.

Earlier, pharmacological compant Pfizer Inc and German ally BioNTech SE had said last week that the vaccine being developed by them was over 90% effective.

According to a senior government scientist, a vaccine, approved and supported by the government is on the cards and could be launched in February as well. If this is anything to go by, the country can be ready with the vaccine months earlier than it previously expected as the last stage clinical trials are starting in November.