New Delhi: A day after the news of two COVID-19 vaccines getting a nod for the restricted use in India was out, several politicians on Sunday (January 3, 2021) hit out at the Bhartiya Janata Party-led government at the Centre and questioned the COVAXIN’s phase 3 trials.
While the Congress MP from Thiruvananthapuram Shashi Tharoor said that the COVAXIN has not yet had Phase 3 trials and approval was ‘premature and could be dangerous’, another Congress leader Jairam Ramesh said that the Bharat Biotech is a first-rate enterprise, but it is ‘puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for COVAXIN’.
Both the MPs also asked for a clarification from Union Health Minister Harsh Vardhan on the coronavirus vaccine.
The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime. https://t.co/H7Gis9UTQb
— Shashi Tharoor (@ShashiTharoor) January 3, 2021
Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister @drharshvardhan should clarify. pic.twitter.com/5HAWZtmW9s
— Jairam Ramesh (@Jairam_Ramesh) January 3, 2021
On the other hand, the Samajwadi Party chief Akhilesh Yadav said the COVID-19 vaccination programme is a ‘sensitive process’ and the Centre should not treat it as a ‘cosmetic’ event as it is a matter of peoples’ lives. Earlier, Yadav had said, “I am not going to get vaccinated for now. How can I trust BJP’s vaccine, when our government will be formed everyone will get free vaccine. We cannot take BJP’s vaccine.”
कोरोना का टीकाकरण एक संवेदनशील प्रक्रिया है इसीलिए भाजपा सरकार इसे कोई सजावटी-दिखावटी इवेंट न समझे और अग्रिम पुख़्ता इंतज़ामों के बाद ही शुरू करे. ये लोगों के जीवन का विषय है अत: इसमें बाद में सुधार का ख़तरा नहीं उठाया जा सकता है.
गरीबों के टीकाकरण की निश्चित तारीख़ घोषित हो.
— Akhilesh Yadav (@yadavakhilesh) January 3, 2021
In reply, Harsh Vardhan said that it’s disgraceful for anyone to politicise such a critical issue and shared the details about COVID-19 vaccine.
The Health Minister tagged all the three politicians on Twitter and asked them to not try to discredit well laid out science-backed protocols followed for approving COVID-19 vaccines.
“Wake up & realise you are only discrediting yourselves!,” Harsh Vardhan tweeted.
He added, “Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%. However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein. So, it’s likely to have similar protective efficacy reported for others.”
Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%
However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein
So,it’s likely to have similar protective efficacy reported for others pic.twitter.com/AOIONrxZcd— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
“COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein. Inactivated virus from NIV also had D614G mutation,” stated Harsh.
He noted that the data from COVAXIN Phase I and II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises CD4 T lymphocytes that imparts durable immune response.
The data from COVAXIN Phase I & II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises CD4 T lymphocytes that imparts durable immune response@BharatBiotech @PMOIndia @ICMRDELHI @icmr_niv @MoHFW_INDIA @DBTIndia pic.twitter.com/SzS6lsOBBG
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
“Our experience with inactivated vaccines not having serious adverse events was also observed in Phase II done among 380 study participants in BBV152 trial in 21280 Person days follow up. No serious adverse events seen. Only 7% persons receiving 6 microgram dose had mild symptoms,” said Health Minister.
He said, “There were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials.”
There were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials.@ICMRDELHI @MoHFW_INDIA @icmr_niv @DBTIndia @BharatBiotech pic.twitter.com/sBU8iKDSxO
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Earlier in the day, Prime Minister Narendra Modi hailed the Drugs Controller General of India (DCGI)’s nod for the Serum Institute’s Covishield and Bharat Biotech’s COVAXIN for restricted use in India.
PM Modi termed the move as a decisive turning point in the country’s fight against the virus and expressed his gratitude for all frontline workers in ‘adverse circumstances’.
A decisive turning point to strengthen a spirited fight!
DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.
Congratulations India.
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) January 3, 2021
The Prime Minister also said, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”
It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.
— Narendra Modi (@narendramodi) January 3, 2021
We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.
— Narendra Modi (@narendramodi) January 3, 2021
Meanwhile, the World Health Organization (WHO) has welcomed India’s COVID-19 vaccine approval and said that the decision will help strengthen the fight against coronavirus.
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