Vaccine will not be released for mass use unless proven immunogenic: Serum Institute

Agencies
December 1, 2020

Pune, Dec 1: Vaccine development company Serum Institute, India on Tuesday said the Covidshield vaccine will not be released for mass use unless it is proven immunogenic, and safe.

The company also said the serious adverse event (SAE) that happened to a city based volunteer though unfortunate was in no way induced by the vaccine.

Serum Institute which had earlier said it would claim over Rs 100 crore damage from the volunteer for damaging its reputation said it was sympathetic with the volunteer's medical condition and the incident is highly unfortunate.

"However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly," the company said.

According to Serum Institute, the concerned authorities were informed and the Principal Investigator, Data Safety Monitoring Board (DSMB) and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial.

"Post which we submitted all the reports and data related to the incident to the DCGI (Drug Controller General of India). It is only after we cleared all the required processes that we continued with the trials," the company said.

"Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned," the company added.

The 40-year-old city based volunteer, who works as a business consultant had wanted to investigate the cause of him contracting severe neurological health complications he had suffered after being vaccinated with Covidshield shots under development at Serum Institute, but the company was intimidating him with a threat of over Rs 100 crore damage suit, his advocates had said.

According to the advocates, their client was vaccinated on September 29 and developed severe neurological health complications and instead of probing the cause and stopping the trials Serum Institute and others kept silent.

"We are yet to get any reply for the legal notice sent to various parties, including Serum Institute. We have seen news reports about Serum Institute threatening our client with a suit for over Rs 100 crore," N.G.R. Prasad, Advocate, Row & Reddy, told IANS.

"Our client had restricted his claim only for Rs 5 crore and wanted investigation to start as to the cause of him suffering severe neurological problems and stop the vaccine from affecting other people," Prasad added.

A family friend of the volunteer told IANS: "He was a healthy young male. He had no pre-existing ailments. Not even blood pressure. But 10 days after the vaccination, he had developed severe neurological complications."

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Agencies
January 19,2021

People with fever, pregnant and breastfeeding women avoid Covaxin, says Bharat Biotech

Pune, Jan 19: Bharat Biotech's fact sheet on COVID-19 vaccine Covaxin, has advised pregnant or breastfeeding women, besides people with high fever or bleeding disorders, not to take the antidote.

The vaccine maker in the fact sheet on Covaxin, posted in its website, said the clinical efficacy of the vaccine is yet to be established and is being studied in Phase 3 clinical trial and hence it is important to appreciate that receiving the vaccine does not mean other precautions related to COVID- 19 need not be followed.

"You should not get Bharat Biotech's COVID-19 vaccine Covaxin if you have any history of allergies. Have high fever.

Have bleeding disorder or are a blood thinner.

Immune compromised or are a medicine that affects your immune system. Are pregnant. Are breast feeding.

Have received another COVID-19 vaccine. Any other serious health related issues, as determined by the vaccinator/ Officer supervising vaccination," the fact sheet said.

The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.

Bharat Biotech said in an ongoing clinical trial Covaxin has been shown to generate immunity following two doses given four weeks apart.

Covaxin is a vaccine with approval for restricted use in emergency situations that may prevent COVID-19.

The Central Licensing Authority has granted permission for the sale or distribution of the antidote for restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, the fact sheet said.

Covaxin is a highly purified and inactivated two-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, the company had said.

Covaxin is India's totally indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology.

The inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) biocontainment facility, one of its kind in the world.

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Agencies
January 12,2021

New Delhi, Jan 12: Amid the ongoing debate around the safety and efficacy aspects of Covid vaccines, the president of Indian Medical Association (IMA) has advised the public to not worry too much about it.

Speaking to IANS, Dr. J.A. Jayalal, president, IMA said, "We should not be too worried about the safety and efficacy of the vaccines since enough evidence is available to prove its credibility.

"The vaccines are never 100 per cent protective and efficacious at any time. It helps us to some extent in getting ahead of the disease but eventually, herd immunity will set in to control the viral spread. So let's not worry too much about the safety and efficacy part," he said.

"What we know from the trials is that the vaccines approved for inoculation in India are found safe and elicit an immune response. The technology of harnessing vaccines from inactivated viruses is a proven science. Our least expected efficacy criteria is 50 per cent while at the same time, other drugs we have been using for years are even below this benchmark of efficacy. We use influenza and vaccines against Tuberculosis but still people contract it," Jayalal explained.

"Even natural infection cannot determine the level of antibodies it would create in the body. Some may develop less antibodies, some may exhibit high titers of it while a few may never develop at all. Good thing is that the vaccines are producing antibodies and it's enough at this stage," he added.

Jayalal also said that the vaccine would work against the current and mutant strains of the coronavirus. Such claim was earlier made by Bharat Biotech for its Covid vaccine, Covaxin, which is approved for restricted emergency use in a clinical trial mode'. However, the firm is yet to present the data confirming its claim.

The apex association of modern medicine practitioners in the country has come out publicly endorsing the safety and efficacy of Covid-19 vaccines. In a statement issued on Monday, it said that the association stands with the scientists to endorse the safety and efficacy of both Covaxin and Covishield for public awareness and to counter myths on vaccine percolating in social media.

The IMA has also appealed to its its 3.5 lakh members in 1,800 local branches to actively take part in the mission of Covid vaccination programme rolled out by the Government of India. "Come out to get vaccinated first to show to the world that these vaccines are safe and efficacious," it had said.

Despite the efficacy of both the vaccines still unknown, the IMA has endorsed the vaccines. When asked about it, Jayalal said the association had a detailed discussion on such aspects with the government agencies. "After analyzing all the scientific data, we have decided to come out firmly in support of the vaccines," he added.

India's drug regulator has approved two Covid vaccine candidates -- Covishield by Serum Institute of India and Covaxin by Bharat Biotech -- for the massive inoculation drive against the Covid-19.

The immunization drive will start from January 16. The vaccines have already reached many of the primary hubs to be distributed further before the roll-out.

Till now, a total 1,51,327 people have succumbed to the deadly disease while it has infected 1,04,79,179 people in the country.

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News Network
January 17,2021

New Delhi, Jan 17: A security guard who was administered a shot of Covaxin at AIIMS on Saturday was admitted at the hospital after he developed an allergic reaction as part of "severe" adverse events following immunisation.

According to AIIMS Director Randeep Guleria, the security guard, in his 20s, at AIIMS who received the jab after 4 pm, complained of palpitations and developed an allergic skin rash within 15-20 minutes after being inoculated and was admitted to the facility.

"He was immediately managed with appropriate treatment and he improved. He is stable. As a precautionary measure he has been admitted for overnight observation and his condition is being monitored. He is likely to be discharged in the morning," Guleria said.

One "severe" and 51 "minor" cases of AEFI (adverse events following immunisation) were reported among healthcare workers who were administered the coronavirus vaccine in Delhi on the first day of the COVID-19 vaccination drive on Saturday, official figures showed.

Against a target of 8,117 health workers to be vaccinated on the first day of the drive in 11 districts of Delhi, a total of 4,319 were administered the vaccine, the figures showed.

Officials said a few cases of AEFI were observed in some people who were administered the vaccine.

"A few AEFI cases were reported but most were minor and the persons were normalised during observation period. Only one severe AEFI case was reported in South Delhi," said a top government official.

According to the World Health Organisation (WHO), any untoward medical occurrence which follows immunisation and does not necessarily have a causal relationship with the usage of the vaccine, is known as AEFI.

Eleven cases of "minor" AEFI were reported from south and southwest districts, showed official data.

The "minor" AEFI cases were reported from all districts except northeast and Shahdara districts, officials said.

Administration of coronavirus vaccine started in Delhi at 81 centres across the city on Saturday. Each Centre was targeted to administer vaccines to 100 people (health workers).

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