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Covid News and Updates

Novovax receives nod from New Zealand for jabbing 18 above

by Vaishali Sharma
written by Vaishali Sharma

Following the government’s approval, New Zealanders will soon be able to get a third form of Novavax vaccination.

According to the Xinhua news agency, Covid Response Minister Chris Hipkins announced on Tuesday that Novavax would soon be available to New Zealanders aged 18 and up.

“Novovax is protein-based Covid vaccine and while the Pfizer Covid vaccine remains the preferred vaccine of most New Zealanders, for some people, the arrival of Novavax will be the extra incentive required to get vaccinated against Covid,” Hipkins said in a statement.

According to Hipkins, New Zealand is already one of the world’s most vaccinated countries, with 95 percent of individuals aged 12 and up receiving vaccinations.

New Zealand officials are working with Novavax to finalise the supply timetable and rollout start date, and the first pills are expected to arrive this month, he said.

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Maharashtra

Covovax being tested in phase 2/3 trials in Pune

by Vaishali Sharma
written by Vaishali Sharma

The Covovax COVID-19 vaccine is being tested in phase 2/3 trials in children aged 7 to 11 at Pune’s Bharati Vidyapeeth Medical College and Hospital.

The Covid vaccination study for children began in India, and the age bracket for enrollment is 2-17 years. COVOVAX is the Indian version of the NOVOVAX vaccination for children, which was introduced in India by the Serum Institute of India.

“Pune’s Bharati Vidyapeeth Medical College Hospital began phase 2/3 trials of Covovax in children between 7 and 11 years of age. Nine children have been enrolled for the trial here,” said Dr Sanjay Lalwani, the Medical Director of the hospital, as quoted by news agency ANI.

“For the children who wish to enrol their parents are counselled in local vernacular language and the audiovisual consulting process is documented. Once the parents give their consent, then the volunteer is subjected to an RT PCR test and an antibody test. Although, this does not stop them from being a part of the trial,” he added.

As many as nine centres have been identified across India for this phase, including Bharati Vidyapeeth Medical College Hospital.

“In paediatric, it’s an age de-escalation trial; which means that you start with children of higher age and see the efficacy, and then proceed to the lower ages. So, part one is between the 11-17 age group where 100s have been enrolled in India. There are 9 sites in India and approx 1,000 children will enrol across the county. We at our site have started the trial for the age group of 7-11,” Lalwani said.

During the trial, two doses at a gap of 21 days will be administered.

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National & International News

India to receive four more arsenals by October

by Vaishali Sharma
written by Vaishali Sharma

According to top government officials, the government expects four additional vaccinations to join its arsenal by October, and it expects to get 20 crore vaccine doses in August and 25 crore doses in September from existing players.

The WHO nod for Bharat Biotech’s Covaxin is also expected this month after August 15 as the government believes the vaccine has met all required criteria and the signs are positive. “Vaccines of Biological-E, Zydus Cadila, Novavax and Gennova are expected by October,” the source said, adding that the approvals from regulators could come through by then and some of these vaccine makers are already doing at-risk production of vaccines.

The source said the government will get 20 crore vaccine doses of Covishield, Covaxin and Sputnik V in August and 25 crore doses in September. “We would be able to do 1 crore daily vaccinations in September,” the source said, adding that supplies of Covaxin are expected to improve from this month.

The government is confident of a third wave of Covid-19 not hitting India, unless the unpredictability of a mutant variant emerges, the source said “We may stay at level of 40000 to 50000 daily cases or rise till about 1 lakh cases in an eventuality but are confident of not going above that,” the government source said.

The government is also confident of fully vaccinating most adults in the country by the end of December and expects that 80 per cent of all adults will be willing to get both doses of the vaccine by then, which a source said would also be a big achievement compared to all other countries. The government is however not banking much on the foreign-made vaccines — Moderna, Pfizer and Johnson & Johnson — as reportedly besides seeking indemnity, some of them were also seeking sovereign guarantees that the Indian government was not willing to give.

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Novovax
Pharma News

Novavax’s Covid-19 vaccine ‘Covavax’ to launch in India by September: Sources

by Vaishali Sharma
written by Vaishali Sharma

The Serum Institute of India (SII) hopes to introduce US firm Novavax’s Indian version of the Covid-19 vaccine – ‘Covavax’ by September this year and start trials on children from July, sources said on Thursday.

The SII is hoping to introduce Covavax in the country by September which is a version of US firm Novavax’s Covid-19 vaccine, sources added.

Earlier this week, Novavax’s vaccine exhibited a 90.4 per cent overall efficacy in Phase-3 clinical trials. That puts it in the same bracket as two of the frontline vaccines being used in the US and European countries, the ones produced by Pfizer-BioNTech and Moderna, which had efficacy rates of 91.3 per cent and 90 per cent in Phase 3 trials, respectively.

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Novovax
Pharma News

Novavax Covid Vaccine, To Be Made By Serum Institute, Shows 90% Efficacy

by Vaishali Sharma
written by Vaishali Sharma

Covid-19 vaccine manufacturing company, Novovax recently announced that it’s vaccines have shown 90 per cent efficacy in a late-stage study carried out in the US and Mexico.

The jab “demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall,” the company said in a statement, adding “the study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity.”

The Maryland-headquartered company said it intended to apply for regulatory approval by the third quarter of 2021.

After that, it said, it would be on course to make 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the year.

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Novovax
Pharma News

Novovax’s combined influenza/Covid-19 vaccine shows efficacy in an animal study

by Vaishali Sharma
written by Vaishali Sharma

Novavax Inc said on Monday its combined flu and Covid-19 vaccine produced functional antibodies against influenza and the coronavirus in a preclinical study.

The company said the NanoFlu/NVX-CoV2373 vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus.

“Seasonal influenza and Covid-19 combination vaccines will likely be critical to combating emerging Covid-19 variants,” said Russell Wilson, the executive vice president and NanoFlu general manager of Novavax.

Hamsters that received the combined vaccine had heightened levels of Covid-19 antibodies two weeks after the first immunization, which increased significantly after a second dose, compared to animals that received the Covid-19 vaccine, NVX-CoV2373, alone, the company said.

Novavax said it expects to start clinical studies of the combined vaccine by the end of 2021.

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Novovax
Pharma News

Novovax firms up deal with Covax for first 350mn jabs

by Vaishali Sharma
written by Vaishali Sharma

Novovax has signed a deal for the first 350 million of its Covid-19 vaccine doses bound for the Covax global vaccine-sharing facility, the US Biotech firm said on Thursday.

Novovax, which signed a memorandum of understanding in February to provide 1.1 billion doses in total, penned an advance purchase agreement with Covax for the first tranche.

They will be supplied, subjected to regulatory approval, from the third quarter of 2021 onwards into 2022.

The Serum Institute of India plant is expected to manufacture and deliver the remaining 750 million Novovax doses.

SII is currently making AstraZeneca vaccine doses which are being blocked from the export for Covax due to domestic demand, as the pandemic explodes in India.

Covax was set up to ensure poor countries have equitable access to vaccines to combat the coronavirus pandemic.

The facility is co-led by the World Health Organization (WHO), the Gavi vaccine alliance and the Coalition for Epidemic Preparedness Innovations.

CEPI invested nearly $400 million in Novovax in early 2020 to help get the vaccine off the ground.

“Today’s agreement with Novovax marks a major step towards Covax’s objective of building the world’s largest and most diverse portfolio of Covid-19 vaccines, a major step towards our goal of delivering two billion doses of safe and effective vaccines in 2021,” said Gavi chief executive Seth Berkley.

96% efficacy – Novovax’s two dose NVX-CoV2373 vaccine injects pieces of the coronavirus to evoke an immune response. It can be stored at regular refrigeration temperatures.

The agreement contains the opportunity for Covax to access potential future versions of the vaccines adapted to new variants.

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Medical NewsNational & International News

Shortfalls of Supplies From US may cause delay, warns SII CEO

by Vaishali Sharma
written by Vaishali Sharma
astrazeneca

The chief scientist of World Health Organization and head of world’s biggest vaccine maker says that a global shortage is being faced by the makers of Covid-19 vaccine.
A US law prohibiting the export of certain key commodities, including bags and filters, would create potentially serious bottlenecks, said Adar Poonawalla the chief executive officer of the Serum Institute of India Ltd. — which is licensed to produce hundreds of millions of Covid-19 vaccines from AstraZeneca Plc and Novavax Inc. Soumya Swaminathan from the WHO added that there were shortfalls of vials, glass, plastic and stoppers required by those companies.
“The Novavax vaccine, which we’re a major manufacturer for, needs these items from the U.S.,” Poonawalla said. “If we’re talking about building capacity all over the world, the sharing of these critical raw materials is going to become a critical limiting factor — nobody has been able to address this so far.”
This is one thing that would need some discussion with the Biden administration to explain to them there’s enough to go around,” he added. “We’re talking about having free global access to vaccines but if we can’t get the raw materials out of the U.S. — that’s going to be a serious limiting factor.”
Despite Poonawalla’s warnings, he said that Serum had in the past two months distributed 90 million doses of AstraZeneca’s vaccine to 51 countries after it was granted emergency authorization by Indian regulators in early January — a record pace for the company.
A meeting will be held on Monday and Tuesday between WHO’s vaccine partners, the International Federation of Pharmaceutical Manufacturers and Associations and the Developing Countries Vaccine Manufacturers Network, to discuss these issues, said Swaminathan.

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