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Oxford vaccine viable even at 60-70% efficacy: Serum Institute

The PM visit will be followed by a visit by ambassadors and High Commissioners from around 100 countries, Pune Divisional Commissioner Saurabh Rao said.

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Covid 19 Vaccine

The AstraZeneca-Oxford vaccine candidate, even at the lowest efficacy of 60-70 per cent, is a viable one against the novel coronavirus, the Serum Institute of India (SII) said on Thursday.

SII has partnered with the University of Oxford and AstraZeneca for the manufacture and distribution of the vaccine candidate.

“Even though the lowest efficacy results are at 60-70%, it is a viable vaccine against the virus. That said, varied age groups with different dosage forms will result in slight variations and efficacy. We must be patient and not panic,” SII said in a statement.

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India trial results not in

The efficacy results of AstraZeneca were based on trials being conducted in the United Kingdom and Brazil. It does not include the trials of the same vaccine being conducted by the Serum Institute in India. The results of the Indian trials are expected to come out in December.

The statement — a couple of days before PM Narendra Modi is scheduled to visit the company — comes amid an acknowledgment on Wednesday by AstraZeneca of a key error in the dosage received by some of the study participants of its Covid-19 vaccine candidate AZD1222 (named Covishield in India).

According to partial results announced on Monday from ongoing trials in the UK and Brazil, the vaccine showed a striking difference in efficacy, depending on the amount delivered. A regimen of two full doses given a month apart was 62 per cent effective while participants who received half a dose of the vaccine in the first round and then the full dose a month later were found to be 90 per cent less likely to develop Covid-19. The average efficacy was pegged around 70 per cent.

But on Wednesday, according to reports, AstraZeneca admitted that the half dose was an error since some of the vials did not have the right vaccine concentration.

In its statement, SII said there were no concerns about the trial in India.

“The Indian trials are running smoothly with strict adherence to all the necessary processes and protocols. So far, there are no concerns. However, we are going through the data that is available and will make a further statement, if needed,” the statement said.

Phase 3 trials are underway across 17 sites in the country and data on the Indian trials should be out in a month or so, SII CEO Adar Poonawalla had earlier told The Indian Express.

While scientists and experts say a vaccine with efficacy of 60 per cent and above is good, they have, however, raised concerns over the company’s communication strategy.

When contacted, Dr Gagandeep Kang, virologist and professor of Christian Medical College, Vellore, said, “You need to be absolutely straight upfront and transparent. We have learnt that the low dose in the Oxford study with higher efficacy was an accident. To first say that low dose gives 90 per cent efficacy and later say that the dose was an error creates doubt about the process that is unnecessary.”

Saying she “trusted the researchers at Oxford”, Kang said, “Usually when the researchers at Oxford work on vaccines, they go all the way through Phase 1 and sometimes through Phase 2 of the trial on their own. I understand that in this case, they were advised to not do everything on their own and as early as possible link up with a large vaccine company. Oxford started to work with AstraZeneca and this error in dosing may have happened in that switch from doing early phase studies themselves and the later trials with AstraZeneca. This would need to be informed to the regulators and in the trial registry.”

However, none of this is any reason to dismiss the vaccine, she said. “This is not a vaccine that should be put in the dustbin just because of 60 per cent efficacy. It is a good vaccine that has exceeded the WHO and FDA benchmarks. There is a lot more data to come and we will learn more when it does,” she said.

Virologist Dr Shahid Jameel said he was intrigued by the results. “As a scientist, I am now thinking what sort of response would one get if the first dose was even smaller – half of what they give — whether by design or accident, I don’t care. Would one get an equal or better response then?” Dr Jameel told.

Calling the results a “blessing in disguise”, he said, “The advantage is that if half or quarter dose gives a better response, then there would be twice as many vaccine doses to vaccinate people. That is a big plus. Many scientific discoveries have happened serendipitously,” he said.

On Saturday, Prime Minister Narendra Modi is set to visit Serum Institute of India “to understand the process of vaccine production and distribution”. Officials said the PM would reach around 1 pm and depart around 2.30 pm.

The PM visit will be followed by a visit by ambassadors and High Commissioners from around 100 countries, Pune Divisional Commissioner Saurabh Rao said.

Health

Congress alleges govt procuring Covid vaccine at inflated prices

The Congress leader said the price of such a vaccine must be cheaper than AstraZeneca-Serum Institute of India’s Covishield.

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New Delhi, Jan 17 : The Congress on Sunday questioned the procurement of Covid vaccines, alleging that the government has procured the vaccines at inflated prices despite the manufacturers claiming they would supply the vaccines without seeking profit.

Congress General Secretary Randeep Singh Surjewala, addressing a press conference, said, “Why should the Modi government pay Rs 95 per dose more to Bharat Biotech for a vaccine that has been developed with the expertise and experience of scientists of government-run ICMR and pay more for a vaccine that has only been tested on 755 individuals and is yet to be cleared after phase-3 trials?”

The Congress leader said the price of such a vaccine must be cheaper than AstraZeneca-Serum Institute of India’s Covishield.

“Why is the price of the vaccine at Rs 1,000 per dose in the open market?” he asked.

Surjewala said, “‘Covishield’ is an AstraZeneca vaccine manufactured by Serum Institute of India. Serum Institute is supplying this vaccine at Rs 200/dose to government. AstraZeneca has committed to supplying the vaccine at no profit while ‘Covaxin’, manufactured by Bharat Biotech, is being supplied at Rs 295/dose. Admittedly, Covaxin has been developed by Bharat Biotech in partnership with Indian Council of Medical Research (ICMR).”

SII CEO Adar Poonawalla had said stated that his company will sell Covishield for Rs 1,000 per dose in open market, that is Rs 2,000 for 2 doses required for every individual.

Surjewala said, “Why should export of vaccine be permitted without immunisation of India’s population? ‘Corona Vaccine For All’ should be the stated policy of Modi government.”

“However, the government’s approach on free vaccination or cost of vaccination, cost to exchequer, profit margins of companies, etc, for India’s 130 crore people is completely opaque and shrouded in secrecy,” he said.

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Health

13 Israelis suffer facial paralysis post inoculation

“For at least 28 hours, I walked around with it (facial paralysis),” one person who had the side effect told Ynet.

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Jerusalem, Jan 17 : At least 13 Israelis suffered mild facial paralysis as a side effect after receiving the first Covid vaccine jabs, the Health Ministry said, adding that the count could be higher.

The officials have raised questions on whether or not to administer the second dose to these individuals the Health Ministry had recommended for the second dose, reported the Jerusalem Post.

“For at least 28 hours, I walked around with it (facial paralysis),” one person who had the side effect told Ynet.

“I can’t say it was completely gone afterwards, but other than that I had no other pains, except a minor pain where the injection was, but there was nothing beyond that.”

As for receiving the second dose, he admits he is undecided, but says that “it is important to note that this is something rare, and I don’t want people to avoid getting vaccinated – it’s important”.

“I recently came across, for example, someone vaccinated who was dealing with paralysis, and decided not to give her a second dose,” Galia Rahav, Director of the Infectious Diseases Unit at Sheba Medical Centre told Ynet.

“It is true that it can be given according to the Health Ministry, but I did not feel comfortable with it.”

She added that, “No one knows if this is connected to the vaccine or not. That’s why I would refrain from giving a second dose to someone who suffered from paralysis after the first dose.”

However, the Health Ministry has assured of the second dose only when the paralysis passes, Ynet reported.

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Delhi reports 51 cases of minor adverse events post vaccination

As many as 1,91,181 people were vaccinated on day one of India’s first phase of the coronavirus vaccination drive.

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Hours after the Health Ministry announced on January 16 that India has reported no case of post-vaccination hospitalisation yet, 51 persons complained of minor adverse events in Delhi. Another person developed severe adverse event following immunization and had to be referred to the AEFI centre.

Out of a total of 4,319 healthcare and frontline workers who were vaccinated on Jnauary 16 in the National Capital, two healthcare workers at NDMC’s Charak Palika Hospital reported mild adverse event post-vaccination including mild tightness in the chest. They were kept under observation by AEFI team and discharged 30 minutes later after they felt at ease. The two other cases were reported from Northern Railway Central Hospital, of which one was referred to the AEFI centre, the Delhi government has informed.

As many as 1,91,181 people were vaccinated on day one of India’s first phase of the coronavirus vaccination drive.

Beneficiaries from 11 states and union territories across India received Covishield or Covaxin shots on the first day of the vaccination drive, namely, Assam, Bihar, Delhi, Haryana, Karnataka, Maharashtra, Odisha, Rajasthan, Tamil Nadu, Telangana, and Uttar Pradesh.

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