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Covid News and Updates

China needs good Covid 19 booster vaccine like Covovax, but they haven’t given a positive response: Adar Poonawalla

by Vaishali Sharma
written by Vaishali Sharma

China requires a decent Covid 19 booster vaccine like Covovax, but so far there has not been a favourable reaction from China, according to Adar Poonawalla, Chief Executive Officer of Serum Institute of India (SII), on Wednesday.

Talking to ANI, Poonawalla said, “Covovax is an excellent vaccine against Omicron. We have got a lot of data and global trials for it. It’s approved in the US and Europe which no other Indian COVID vaccine has. Let’s see how it goes.” “We haven’t received positive response from China. They need a good booster like our Covovax vaccine which is approved by DCGI and will soon be available on the COVID app,” he added.

According to sources, NTAGI will likely meet shortly to discuss the inclusion of Covid vaccination Covovax on the CoWIN site as a heterologous booster dosage for adults in order to increase booster dose uptake.
The Serum Institute of India has also written to the Union Health Ministry, requesting that their Covid vaccination Covovax be included on the CoWIN site.

The Drugs Controller General of India (DCGI) accepted the market authorization for Serum Institute of India (SII) COVID jab Covovax as a heterologous booster dosage on January 16.

Notably, the government panel of the Drugs Controller General of India (DCGI) has recommended market approval for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dosage for patients who have already received two doses of Covishield or Covaxin.

Adar further stated that SII is working on a malaria vaccine for Africa. The dengue vaccine is being developed and is anticipated to be ready in two years.

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Covid News and Updates

Govt panel has approved phase-3 study of Covovax as booster dosage

by Pragati Singh
written by Pragati Singh

Official sources informed PTI on Sunday, March 6, that an expert panel of India’s federal drug regulator has recommended clearance for a phase-3 clinical study of COVID-19 vaccine Covovax as a booster dose in adults. On December 28, the Drugs Controller General of India (DCGI) authorised Covovax for limited usage in adults in emergency situations.
It has not yet been incorporated into the country’s immunisation programme. On Friday, the Central Drugs Standard Control Organization’s Subject Expert Committee on COVID-19 recommended that approval be granted for a phase-3 clinical study of the single-dose COVID-19 vaccine Sputnik Light as a booster dose.

An official source said that Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India, had sought approval from the DCGI to conduct a phase-3, observer-blind, randomised, controlled study to assess the safety and immunogenicity of Covovax as a booster dose in adults who had been vaccinated with Covishield or Covaxin at least 3 months ago.
Given the unknowns surrounding the COVID-19 pandemic, Singh noted that several nations have already begun delivering booster doses to their populations. “We are certain that your clearance for this clinical study will result in the early availability of Covovax for booster dosage usage for people in our country and throughout the world, in keeping with our Prime Minister’s goal of ‘Making in India for the World.'”

“Under the innovative leadership of our CEO Adar C Poonawalla, our company is devoted to offering world-class life-saving vaccinations at an accessible price. We respectfully seek that you grant us permission to undertake a phase 3 clinical study in Indian adults for a booster dosage of Covovax “According to reports, Singh stated in his application.

Covovax is a product of Novavax’s technology transfer. The European Medicines Agency awarded it conditional marketing authorization, and the World Health Organization added it to the list of emergency drugs.

Novavax Inc, located in the United States, signed a licencing deal with Serum Institute of India in August 2020 for the development and commercialization of NVX-CoV2373, their COVID-19 vaccine candidate, in poor and middle-income countries, as well as India.

 

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Covid News and Updates

EUA for Covid vaccine Covovax for 12-17 age group, recommended by Government panel

by Pragati Singh
written by Pragati Singh

Official sources said on Friday that an expert panel of the country’s federal drug regulator recommended awarding emergency use authorisation (EUA) to Serum Institute of India’s COVID-19 vaccine Covovax for the 12-17 age range.

On December 28, the Drugs Controller General of India (DCGI) authorised Covovax for limited usage in emergency situations in adults.

It is yet to be incorporated into the country’s immunisation campaign.

On February 21, Prakash Kumar Singh, Director-Government and Regulatory Affairs at the Serum Institute of India (SII), applied to the DCGI for an EUA for Covovax for children aged 12 to 17.

On Friday, the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee on COVID-19 debated on SII’s application and recommended that Covovax be granted EUA.

According to sources, the recommendation will be given to the DCGI for approval.

Singh is said to have indicated in the EUA application that results from two trials involving around 2,700 children aged 12 to 17 years suggest that Covovax is highly effective, immunogenic, safe, and well tolerated in this age range.

“This permission will benefit not just our nation, but the whole globe, bringing our Prime Minister’s goal of “Making in India for the World” to fruition.

We are confident that, in keeping with our CEO Adar C Poonawalla’s philosophy, Covovax will play an important role in protecting children in our country and around the world from COVID-19 disease, and will keep our national flag flying high around the world “Singh had previously stated in the application, according to an official source.

Covovax is made through a technology transfer from Novavax and has been awarded conditional marketing authorisation by the European Medicines Agency, as well as emergency use listing by the World Health Organization (WHO) in December 2017 and 2020.

 

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Pharma News

Covovax, Corbevax and Molnupiravir pill receive Centre’s nod in a single day

by Vaishali Sharma
written by Vaishali Sharma

Today, the centre approved two additional vaccines and one antiviral medicine to help battle the COVID-19 pandemic. Corbevax and Covovax are the two most recent vaccinations approved by India. During an emergency, the antiviral medication Molnupiravir can be utilised.

In a tweet, the minister said, “Congratulations India. Further strengthening the fight against COVID-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: – CORBEVAX vaccine – COVOVAX vaccine – Anti-viral drug Molnupiravir For restricted use in an emergency situation”.

The announcement by Union Health Minister Mansukh Mandaviya on Tuesday came a day after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.

It also had recommended granting restricted emergency use approval to the drug Molnupiravir for treatment of adult patients with COVID-19 and who have high risk of progression of the disease.

With this approval, the number of Covid vaccines which have received emergency use authorisation in the country has increased to eight.

So far six COVID-19 vaccines — Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and the US-made Moderna and Johnson and Johnson — have received emergency use authorisation from the Indian drug regulator.

CORBEVAX Covid vaccine: CORBEVAX vaccine is India’s 1st indigenously developed RBD protein sub-unit vaccine against COVID19, Made by Hyderabad-based firm Biological-E.

COVOVAX Covid vaccine: The Nanoparticle Vaccine, COVOVAX, will be manufactured by Pune-based firm Serum Institute of India.

Molnupiravir covid pill: Molnupiravir, an antiviral drug, will now be manufactured in the country by 13 companies for restricted use under emergency situation for the treatment of adult patients with COVID-19 and who have a high risk of progression of the disease.

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Pharma News

Serum Institute seeks permit from DCGI for Covovax

by Vaishali Sharma
written by Vaishali Sharma

Official sources said the Serum Institute of India applied to the Drugs Controller General of India (DCGI) on Friday for approval to manufacture COVID-19 vaccine Covovax for restricted usage in emergency scenarios at its Manjari production facility.

Along with its application, the business has filed an interim phase 2/3 clinical research report on Indian adults, as well as interim reports from Novavax UK and the USA-Mexico phase-3 clinical study, as well as responses to the DCGI office’s questions.

There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.

“In our government’s endeavour to fight against COVID-19 pandemic, we have also been working shoulder to shoulder with the Government of India to make available one more safe and efficacious world class COVID-19 vaccine for our country and the world at large.

“Approval of our COVOVAX and its availability will further strengthen India’s capability to fight COVID-19 pandemic and ensure vaccine security in line with our prime minister’s clarion call of Atmanirbhar Bharat,” an official so far, stated the application.

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