New Delhi: RTI activist Saket Gokhale on Wednesday made shocking claims through a Facebook post saying there was a mystery in vaccine trials of Bharat Biotech’s Phase 1 and 2.
According to Gokhale, Bharat Biotech registered its Phase 1 and 2 trials for Covaxin with India’s Clinical Trials Registry (CTR) – a division of ICMR – which happens to be Bharat Biotech’s partner. He claimed that Bharat Biotech registered Phase 1 details on July 1, 2020.
“Remember - this was the time when ICMR issued a shocking letter saying "vaccine must be ready by Independence Day" so that PM Modi could earn brownie point,” he wrote in the post.
He also shared pictures which added that Phase 1 registered on July 1, 2020, was to take eight months i.e. by March 2021 but details of Phase 2 were registered on September 8, 2020, even before Phase 1 was completed.
“This was literally within 2 months of registering Phase 1 trial” he added.
“Now let's look at the duration of Phase 1 & Phase 2 trials as declared by Bharat Biotech themselves. Phase 1 (registered on 1 Jul 2020) was to take 8 months i.e. by March 2021. Phase 2 (registered on 8 Sep 2020) was to take 1 year & 3 months i.e. by December 2021. Phase 3 of Covaxin trials were registered on 9th November 2020 with a sample size of 25,800 participants. Registered duration for Phase 3 is 1 year i.e. by Nov 2021” he wrote in the post.
“Basically, Bharat Biotech registered Phase 2 & Phase 3 trials before Phase 1 was not even completed,” he said.
“To sum it up: Phase 1 to be completed by Mar 2021, Phase 2 to be completed by Dec 2021, Phase 3 to be completed by Nov 2021 (that's, bizarrely, 1 month BEFORE Phase 2). And yet - Bharat Biotech's Covaxin has been approved by the Indian govt in January 2021” he added.
“On what basis was this approval given when, by Bharat Biotech's own registration documents, Phase 1 completion is still 3 months away? Is this why the Modi govt is reluctant to share data for Bharat Biotech's Phase 1 & 2 trials publicly? The TOTAL number of volunteers in Bharat Biotech's Phase 1 AND 2 trials is 1249 people. For a country with a population of 1.3 billion people. How on earth is this vaccine "110% safe" & "works against the mutated strain"? Where's the Phase 1 & 2 data to prove this?” Gokhale questioned.
Gokhale demanded that the Modi government must immediately release the Phase 1 and Phase 2 data of Bharat Biotech’s Covaxin trials to the public. “It must also explain how trials, which were supposed to take 1.5 years, got done in 5 months. The reluctance to share any data is a massive red flag” he further wrote.
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Gaborone (Botswana) (PTI): Amoj Jacob and Ragul Kumar got injured during the men's 4x400m and 4x100 races respectively as India ended their World Athletics Relays campaign in disappointment on the second day of competitions here on Sunday.
The Indian camp had high hopes of making the 2027 World Championships in the men's 4x400m relay but the team did not finish (DNF) the race as Jacob suffered cramps and pulled out of the race after taking the baton from the first leg runner Dharamveer Choudhary. Rajesh Ramesh and Vishal TK were to run in the third and fourth legs.
Those teams which could not qualify for the 2027 Beijing World Championships by reaching the final round of each of the six relay events on Saturday were given another chance in the second qualification round on Sunday.
The top two teams in each of the two heats (in all six relay events) booked the Beijing ticket on Sunday.
India will now have to try and qualify for the World Championships through the Top Lists of the World Athletics, which is a long and tedious process.
In the men's 4x100m race, third leg runner Ragul Kumar fell down the track after failing to hand over the baton inside the exchange zone to fourth leg runner Gurindervir Singh, which clearly showed the lack of coordination among the runners.
Harsh Santosh Raut and Animesh Kujur ran the first two legs.
The Indian quartet was disqualified and Kumar was seen being taken away from the Field of Play with the help of the volunteers.
It was a comedy of errors in the case of the women's 4x100m race, which saw the baton being dropped during an exchange between first leg runner Tamanna and second runner Nithya Gandhe, though the Indians finished the race in 53.09 seconds.
Gandhe started running quite a distance, but after realising that the baton was not in her hand, she turned and ran back to pick it up.
The only silver-lining for the Indian contingent was the national record time in the mixed 4x100m relay race, though the quartet of Ragul Kumar, Nithya Gandhe, Animesh Kujur and Sneha SS finished sixth in heat number two with a time of 41.35 seconds, bettering the previous national mark of 42.30 seconds set in March in Chandigarh.
The mixed 4x400m relay quartet of Theerthesh P Shetty, Kumari Saloni, Nihal William and Rashdeep Kaur ended at fifth in heat number one with a time of 3 minutes and 19.40 seconds.
On Saturday, all the five Indian relay teams had failed to make it to the respective final rounds and thus missed out on the 2027 World Championships berths.
