It seems Modi's India is ready to launch the world's first COVID19
vaccine on 15 August.
Sukla Sen in his email says there are 4 essential stages to go through:
first on animals and then three successive stages on humans.
Only on successfully clearing the preceding stage, the stage involving
human volunteers, is taken up.
There is no evidence in the public domain that even the very first stage
on animals has been duly carried out.
Now, the three successive stages are to be compressed - perhaps skipping
a stage or two, under pressure to meet the (absurd) deadline of August
15.
Perhaps, the plan is just not to showcase another grand achievement
under Modi, but also to place a huge order on the private enterprise
involved in developing the vaccine together with the ICMR.
Last week, a letter from the Indian Council of Medical Research (ICMR)
claiming that India would have a COVID-19 vaccine ready for public use
by August 15 was roundly panned by scientists. The letter, written by
ICMR director general Balram Bhargava, was addressed to 12 hospitals.
Bhargava asked them to begin recruiting participants for human trials
for the vaccine by July 7.
Experts familiar with vaccine trials quickly pointed out that both the
July 7 and August 15 deadlines were ridiculous, given the vaccine had
only been tested on animals thus far (with no result made public).
...
Vaccine development typically has multiple stages. Skipping or
shortening any of these phases could lead to a potentially ineffective
or dangerous vaccine reaching people.
...
Bharat Biotech has not published any data from its animal trials. As a
result, it’s more crucial that the phase 1 human studies that follow are
conducted with utmost care.
...
“The wording of the letter is absolutely wrong. It would lead to the
breaking down of systems you have worked very hard to create. You need
to speed up, but you certainly can’t bulldoze people into doing a
trial,” Jacob John, a professor of community medicine at the Christian
Medical College, Vellore, who was involved in developing India’s first
indigenous rotavirus vaccine, told The Wire Science.
Several vaccine developers are conducting challenge studies to be safe.
This is because the studies’ results can help them predict whether their
vaccine will worsen COVID-19 instead of suppressing it, a phenomenon
known as vaccine-enhanced disease. This could occur in two ways:
antibody-dependent enhancement (ADE) and vaccine-associated enhanced
respiratory disease (VAERD).
Bharat Biotech has not published any data from its animal trials, so
it’s unknown if it conducted studies to evaluate the potential for ADE
or VAERD. As a result, it’s more crucial that the phase 1 human studies
that follow are conducted with utmost care.
ICMR Must Decide if it Is India’s Council for Medical Research or its
Master’s Voice.
There are around 120 coronavirus vaccine programmes under way
"For these reasons, the Indian Academy of Sciences believes that the
announced timeline is unreasonable and without precedent, and is
therefore issuing this statement in the public interest. The Academy
strongly believes that any hasty solution that may compromise rigorous
scientific processes and standards will likely have long-term adverse
impacts of unforeseen magnitude on citizens of India."
On behalf of the Council and the Fellowship of the Indian Academy of
Sciences,
Partha P. Majumder
President, Indian Academy of Sciences, Bengaluru
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Forwarded by Eddie
