Swissmedic authorised the immunisation of children aged five to eleven years old with Pfizer-Comirnaty Biontech’s vaccine on Friday.
“Clinical trial results show that the vaccine is safe and effective in this age group,” it said in a statement.
Officials in the United States have approved a new COVID-19 antibody medication for persons with major health issues or allergies who are unable to receive appropriate protection via immunisation.
The Food and Medication Administration authorised AstraZeneca’s drug combination emergency use on Wednesday.
Cancer patients, organ transplant recipients, and persons with severe vaccine allergies may benefit from the medicine. According to health professionals, around 2% to 3% of the US population falls into this category.
Other antibody medications are used to treat COVID-19 infection or to prevent infection following probable viral exposure. The new AstraZeneca medicine is meant to be used as a long-term preventative measure rather than a therapy.
According to a new research, the vaccination efficacy of Covishield against COVID-19 infection in fully vaccinated persons was shown to be 63% during April and May, when the second wave was at its height in India.
It was published in the journal ‘The Lancet Infectious Diseases’ and featured a comparison of 2,379 confirmed SARS-CoV-2 infections and 1,981 controls.
The vaccine’s efficacy against SARS-CoV-2 infection was reported to be 63% in completely vaccinated persons.
The Science and Technology Ministry shared the study in an official statement.
“More importantly, the scientists also observed that the spike-specific T-cell responses were conserved against both the delta variant and wild-type SARS-CoV-2. Such cellular immune protection might compensate for waning humoral immunity against the virus variants and prevent moderate-to-severe disease and need for hospitalisation,” the study said.
The ministry said this study provides comprehensive data on the real-world vaccine effectiveness and immunological response to vaccination which should help guide policy.
A multi-institutional team of Indian researchers led by Translational Health Science and Technology Institute (THSTI) evaluated the real-world vaccine effectiveness of Covishield during the SARS-CoV-2 infection surge between April and May, 2021, in India.
They also assessed neutralising activity and cellular immune responses against the variants in healthy vaccinated persons to understand the mechanisms of protection.
The Delhi government designated Lok Nayak hospital on Tuesday for the treatment of Sars-CoV-2 patients infected with the novel Omicron type. According to an order issued by SM Ali, special secretary for health, “Lok Nayak would designate one or more different wards (when needed) for isolating and treating such patients [those revealing the presence of the new variety].”
Referring to the development in a tweet, health minister Satyendar Jain said the Delhi government was “fully prepared” to fight the new variant of coronavirus, which has been declared a variant of concern by WHO.”Hereby, we are designating Lok Nayak hospital as a dedicated hospital to treat the new variant of coronavirus (Omicron),” he said.
As per government officials, [international] travellers are also being allowed to isolate in four private hospitals in the city as paid facility.
This comes after the meeting of Delhi Disaster Management Authority (DDMA) on Monday, after which deputy CM Manish Sisodia said the state was prepared to tackle any rise in Covid-19 infections. All passengers arriving in Delhi from “at-risk” countries, including all of Europe, will need to take an RT-PCR test at the airport and will have to quarantine at home for at least eight days even if their samples return negative, senior state officials said.
According to authorities, at least one tourist from Germany has been hospitalised to Medanta hospital in Delhi, where he is suspected of being infected with the new type. His sample has already been sent to the National Centers for Disease Control and Prevention for genome sequencing, and a result is expected soon.
Meanwhile, the government is looking into two clusters of Covid-19 infections in Maharashtra and Karnataka to see if the new version is present. There have been no verified cases of the new variety in the nation as of yet.
According to the pricing breakdown provided by the firm, the three-dose needle-free COVID-19 vaccine from zydus Cadila would cost the Centre Rs 1,128. On November 8, the pharma company said that it had acquired a purchase order from the Union government to deliver one crore doses of ZyCoV-D at a cost of Rs 265 per dosage, excluding jet applicator and GST.
“Zydus Cadila has obtained an order from the Government of India to provide one crore doses of ZyCoV-D, the world’s first Plasmid DNA Vaccine, for Rs 265 per dosage and the needle-free applicator at Rs 93 per dose, excluding GST,” the pharma business said in a regulatory filing.
According to the price break up, a single dose of the vaccine will be made available to the Centre at Rs 376 which includes the cost of the jet applicator and GST, taking the price of 3-dose jab to Rs 1,128.
The vaccine maker said that the pricing has been decided in consultation with the Centre.
The vaccine will be administered using a needle-free applicator, called PharmaJet, instead of traditional syringes.
The PharmaJet is a needle-free applicator to ensure painless intradermal vaccine delivery which also leads to a significant reduction in any kind of major side effects.
ZyCoV-D is the first DNA plasmid vaccine in the world for human use, developed indigenously by the company against the COVID-19 virus, Zydus Cadila said.
The firm said that ZyCov-D has shown good stability at temperatures of around 25 degrees for at least three months.
ZyCoV-D is the first vaccine cleared by India’s drug regulator for inoculation of those aged 12 years and above.
The three doses of ZyCoV-D, are to be administered 28 days apart. The vaccine was given emergency use authorization (EUA) by the Indian drug regulator on August 20.
The novel AY.4.2 coronavirus mutation accounts for less than 0.1 percent of all variations of interest or concern at the present, according to the Indian SARS-CoV-2 Genomics Consortium (INSACOG) in its weekly report on Sunday.
According to the panel, the frequency is now too low to be worrying, and vaccination efficacy against it does not appear to vary from that of other Delta variants.
“There is currently no biological basis for increased transmissibility of AY.4.2, as judged epidemiologically, and assays are in progress,” it said.
The INSACOG noted that Delta (B.1.617.2 and AY.x) continues to be the main variant of concern in India and no new variant of interest have been noted till now.
Delta, which was first found in India in October last year, led to the devastating second wave of the coronavirus pandemic in the country, which was at its peak in April and May.
The AY.4.2 was reported to be expanding in England in July this year.
Experts in the UK had said that AY.4.2 contains mutations that might give the coronavirus which causes Covid-19 a greater survival advantage.
“A Delta sublineage newly designated as AY.4.2 is noted to be expanding in England. It is now a signal in monitoring, and assessment has commenced; there are also small numbers of new cases of Delta with E484K and Delta with E484Q,” the UK health security agency had said.
The strain was also detected in at least 30 more countries.
In India, Karnataka had last month reported seven cases of Delta Plus, including two AY.4.2. Three such cases were reported in Bengaluru and the remaining four in different parts of the state.
There were no reports of deaths due to the new variant but around two people were hospitalised.
Union health minister Mansukh Mandaviya had said that a government panel of experts was looking into AY.4.2.
INSACOG, a consortium of 28 national laboratories, was set up in December 2020 to monitor the genomic variations in SARS-CoV-2, the Covid-19 causing virus. The pan-India network functions under the Union health ministry.
News18.com has learned that Johnson & Johnson’s Covid-19 vaccine shots, manufactured in India by Hyderabad-based Biological E, are ready for export.
The country’s apex laboratory, the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, cleared six batches of more than one crore doses for safety last week.
“The doses have been cleared by the CDL in Kasauli. The company has expressed the intent to export those doses. According to Form 28 (required for the grant of licence) filled by the company, the vaccine will be exported,” a senior government official at the Ministry of Health and Family Welfare told News18.com. “Once the Drug Controller General of India (DCGI) approves the report sent by CDL and the request filed by the company, the batches can be exported.”
The move is in line with Prime Minister Narendra Modi’s announcement at the Quad Summit in September.
“India will make available 8 million (80 lakh) doses of the Johnson & Johnson vaccine by the end of October under the Quad vaccine partnership,” Foreign Secretary Harsh Vardhan Shringla had said while adding that PM Modi had made an announcement to the effect at the summit. Shringla also said that the Quad nations, including India, will pay for the vaccines.
Since September, the vaccine batches were stuck at the CDL due to pending data, News18.com had reported earlier.
“Finally, the pending data was submitted by the company late October. Last Friday, the report by CDL was received by the DCGI’s office clearing the vaccines for safety,” said the official quoted above.
A Johnson & Johnson India spokesperson told News18 that it is “premature” to speculate on the timing of vaccine deliveries. “Our teams are working around the clock to develop and broadly activate our manufacturing capabilities to supply our Covid-19 vaccine. We believe Biological E will be an important part of our global Covid-19 vaccine supply chain network, helping to supply our vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility. It is premature for us to speculate on the timing of our vaccine deliveries,” the spokesperson said.
The United States Food and Drug Administration will need more time to decide whether to approve Moderna’s COVID-19 vaccine for use in children aged 12 to 17, the company announced on Sunday.
The extra time allows the FDA to investigate reports of a rare side effect — myocarditis, or inflammation of the heart muscle — in those who received the shot. The FDA notified Moderna of the delay on Friday, according to the company.
“The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” Moderna said in a statement.
The government’s review of Moderna’s application for an emergency use authorization of its coronavirus vaccine in adolescents may not be completed before January, the company said. Moderna requested the FDA’s authorization for use in adolescents in June.
The FDA is reviewing “recent international analyses” of the possible side effect, according to Moderna.
A recent unpublished study by Sweden’s Public Health Agency showed a slightly increased risk of inflammation of the heart muscle and prompted four countries to stop giving the shot to young men and boys. The company’s vaccine had previously been approved by The European Medicines Agency for use in children between ages 12 and 17.
Moderna said it did not yet have access to the recent international analyses. The company estimated that more than 1.5 million adolescents had received its vaccine and said there didn’t appear to be an increased risk of myocarditis in those younger than 18.
Both the Modern and Pfizer-BioNTech COVID-19 vaccines have been shown to produce myocarditis as a rare side effect. However, viral infections, including COVID-19, also can cause myocarditis. Most children and adolescents who experience myocarditis recover.
The FDA recently authorized the use of Pfizer-BioNTech’s COVID-19 vaccine in children ages 5 to 11 on an emergency basis. Experts on the advisory panel said the benefits of protecting children against COVID-19 outweigh the possible increased risk of the rare side effect.
Moderna has already been granted emergency use authorization for its COVID-19 vaccine in adults.
The company said Sunday that it would delay applying for emergency authorization for its vaccine to be given to children ages 6 to 11 until the FDA completes its current review.
New Delhi: The Centre has negotiated the price of Zydus Cadila’s Covid-19 vaccine ZyCoV-D and plans to introduce it into the public immunisation programme within the next few weeks. This will entail starting vaccinations for children aged 12 and up who have comorbidities.
“The pricing of the ZyCoV-D vaccine has been finalised,” said Health Minister Mansukh Mandaviya. The manufacturers began production as soon as they received emergency use authorization from the Drug Controller General of India (DCGI).”
When asked when will the vaccine be introduced in the public immunisation drive, the health minister replied, “Turant hee (Immediately).”
The business daily citing sources mentioned that, the government has negotiated the pricing of the vaccine which is “much lower than what the manufacturers had demanded but more than what the government is paying for Covaxin and Covishield”.
Zydus Cadila had received EUA from DCGI for ZyCoV-D on August 20. ZyCoV-D is a three-dose vaccine which is administered using a special syringe. The Centre has been training healthcare workers in administering this vaccine.
The government will introduce the vaccine for children 12 years and above. The first priority group will be children with comorbidities like cancer, respiratory, neurological, rheumatic, cardiac, liver, gastrointestinal, genitourinary and developmental disorders. This will be the first children’s vaccine in India.
If you take the vaccine at private hospitals then it is going to cost you more as they need to negotiate the price with the manufacturer separately.
Even as the government is paving the way for immunisation of children above 12 years of age, it is treading carefully on vaccination of children between 2 and 12 years.
Novartis intends to purchase bulk mRNA active ingredient from BioNTech and fill it into sterile vials for shipment back to BioNTech for distribution.
Novartis has agreed to expand its fill-and-finish support for the Pfizer/BioNTech COVID-19 vaccine by using manufacturing facilities in Ljubljana, Slovenia, to fill at least 24 million doses in 2022, according to the Swiss drugmaker.
Novartis intends to purchase bulk mRNA active ingredient from BioNTech and fill it into sterile vials for shipment back to BioNTech for distribution.
This new agreement builds on an earlier agreement for the fill and finish of more than 50 million doses at the Novartis Stein site in Switzerland in 2021.