August 26, 2020 9:46:48 am
Coronavirus (COVID-19) Vaccine Tracker: Moderna, a US biotechnology company considered to be one of the leading contenders to develop a vaccine for novel Coronavirus, has claimed that the immune response triggered by its candidate vaccine among a small set of older patients was similar to that seen in younger people during trials.
The latest claims are based on an additional early phase trial of the vaccine on 20 people aged 56 years or above. Read in Malayalam
The results hold promise of the vaccine being equally effective in protecting the older people against the Covid-19 disease as the younger adults. Older people have been found to be much more susceptible to the disease, and have a far greater fatality rate.
The company said that the vaccine also appeared to be well tolerated by the subjects of the trials, and no serious adverse impacts was observed. Some patients did report fatigue, headaches and pain, but these are expected side-effects, and were over within two days, it said.
Oxford University vaccine trials in India begin
Phase-2 trials of the Oxford University vaccine for novel Coronavirus began in India Wednesday, with the first doses being given to a set of six volunteers at Pune’s Bharati Vidyapeeth medical college and hospital. This vaccine, developed in collaboration with AstraZeneca, is considered the most promising to be successful, and is undergoing phase-3 trials in some other countries.
Indian regulatory rules require a vaccine to be tested within India for it to be authorised for use on Indian population. Accordingly, Pune’s Serum Institute of India, which has an agreement with AstraZeneca to produce and market this vaccine in India and many other countries, has initiated human trials. Both phase-2 and phase-3 trials would take place in India. Phase-1, during which the vaccine’s safety is assessed, is not mandatory to be repeated in India.
The phase-2 trials will take place at two more locations, at the KEM hospital in Mumbai and PGI, Chandigarh. Several more hospitals would be involved in phase-3 trials, during which the vaccine’s efficacy, or its ability to protect the volunteers from the disease in real life situations, is assessed. In phase-3, the vaccine is tried on several thousand volunteers. However, since these tests are only being repeated in India, a total of 1,600 volunteers are expected to be given the vaccine during the phase-2 and phase-3 trials in India.
Fauci argues against emergency authorisation of a vaccine in development
Anthony Fauci, a top US expert on infectious diseases who is one of the most trusted voices on the current epidemic, has argued against granting emergency use authorisations (EUA) to novel Coronavirus vaccines, to allow its use even before the completion of all the necessary tests.
Fauci’s comments came in the backdrop of reports that have suggested that US President Donald Trump was preparing to grant emergency authorisation to at least one leading Coronavirus vaccine candidate ahead of the November 3 Presidential election. Trump is seeking a re-election, and the availability of a vaccine could boost his chances.
“The one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy… One of the potential dangers, if you prematurely let a vaccine out, is that it would make it difficult, if not impossible, for other vaccines to enrol people in their trials,” Fauci was quoted by Reuters as having said in an interview.
“To me, it is absolutely paramount that you definitively show that a vaccine is safe and effective, both… We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective,” he said.
Meanwhile, the Food and Drug Administration (FDA), the US drug regulator, has fended off Trump’s accusation that a “deep state” within the agency was deliberately slowing down the development of Coronavirus vaccines. A few days ago, Trump had claimed that this “deep state” with the FDA was working to sabotage his re-election bid, and one of the ways of doing it was to delay the vaccine.
In response, FDA boss Stephen Hahn has said there was no “deep state” within the agency, and all decisions on the authorisation of any vaccine would only be taken on the basis of science.
“I have not seen anything that I would consider to be “deep state” at the FDA,” Dr Stephen Hahn, head of the FDA, was quoted by Reuters as saying.
Hahn said he would not be part of a decision that was not based on science. “…what I can tell you is that I will not participate in a decision at FDA that’s made upon anything other than data and science. That, I can assure you,” he said.
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India says in talks with Russia on Sputnik-V vaccine
India on Tuesday said it had been discussing the possibility of bringing the Russian vaccine against novel Coronavirus, called Sputnik-V, with the Russian authorities.
“As far as Sputnik-V vaccine is concerned, India and Russia are in communication. Some initial information has been shared,” Health Secretary Rajesh Bhushan said at a press conference.
Russia has also said that India was one of the countries where the vaccine could be manufactured. It is not clear how concrete these talks have been, or whether any decision to bring the Russian vaccine to India has already been taken.
The Russian vaccine, the first to be authorised for general use, has attracted a great degree of scepticism from the global scientific community, because of the superfast speed in which it was developed and authorised, without going through phase-3 human trials, which are considered necessary to assess the effectiveness of any vaccine.
Hunt for Coronavirus vaccine: The story so far
- More than 170 vaccine candidates in pre-clinical or clinical trials
- 31 of them in clinical trials
- Six in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
(As on August 25; source: WHO Coronavirus vaccine landscape of August 25, 2020)
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