12 including ABVP leader held for CBSE paper leak

If everything goes as Russia’s expectation, it will be world’s first country to approve a coronavirus vaccine for widespread in the second week of August despite safety and efficacy concerns, according to a report. The adenoviral vector-based vaccine developed by Russian military and government researchers is currently in phase 2 trials.

According to a report from CNN, Russian officials are hoping to get approval for the COVID-19 vaccine developed by the Moscow-based Gamaleya Institute on Agust 10 or even before that. The officials told the outlet that the vaccine will be approved for public use with frontline healthcare workers receiving it first.

“It’s a Sputnik moment,” said Kirill Dmitriev, head of Russia’s sovereign wealth fund, which is financing Russian vaccine research, referring to the successful 1957 launch of the world’s first satellite by the Soviet Union, according to CNN.

“Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have got there first,” he was quoted as saying.

However, Russia is yet to release the scientific data on its coronavirus vaccine trials, hence, questions remain about the safety and efficacy of the vaccine, said the report. The vaccine is in the second phase of testing with developers planning to launch the phase 3 trials sometime after August 3.

Earlier, Interfax reported, citing Health Minister Mikhail Murashko, that the vaccine will be widely used in parallel with phase 3 trials. He said the country plans to vaccinate medics who are at high-risk for COVID-19 next month before clinical trials are completed.

Murashko added that individuals at higher risk of getting infected with the coronavirus such as older people or those with health conditions will also be prioritised for the vaccine, although he did not estimate or reveal when that would happen. The minister added 800 people will be recruited for the phase 3 trials.

Meanwhile, health officials were more cautious considering the fact that human testing of the vaccine is incomplete, and the state registration is expected to begin after August 3, reported The Moscow Times.

On Monday, Moderna and Pfizer announced the commencement of the final phase 3 trials of their candidate vaccines against the SARS-CoV-2 virus, which has so far claimed at least 654,477 lives and infected 16,514,500 people worldwide. 

Researchers will recruit up to 30,000 volunteers in separate trials both backed by the US government. India's first indigenous coronavirus vaccine, COVAXIN, is undergoing phase 1 human clinical trials across the country. More than 150 COVID-19 vaccines are being developed all over the world with at least six candidates already in late-stage clinical trials.

The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

Government officials said that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said.

"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India,  the officials said.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said.

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for Covid-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. 

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.

To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.