Novavax | Business Upturn

Novavax applies for WHO’s EUL listing

News Desk — Fri, 05 Nov 2021 06:43:24 +0000

Days after gaining its first emergency use authorization from Indonesia, the business submitted to the health agency all modules required for the evaluation of NVX-CoV2373, its protein-based COVID-19 vaccine. In addition, the business expects regulators in countries such as India and the Philippines to make decisions on its vaccine in the coming weeks.

If the WHO gives its approval, Novavax will be able to start distributing doses to the COVAX programme, which provides vaccines to low-income countries. Novavax is ready to ship its vaccine all around the world, according to Stanley Erck, CEO and Director-Novavax. During a call Erck mentioned that Novavax’s partner, Serum Institute of India, has already created “tens of millions” of doses that are ready to export.

According to the corporation, it is on pace to petition for US approval by the end of the year. It also plans to give booster doses to high- and low-income countries around the world, as well as file a regulatory application for its children’s vaccines in the first quarter of 2021.

The vaccine producer from Maryland reported a larger third-quarter net loss of $322.4 million, or $4.31 per share, compared to $197.3 million a year ago. Increased development operations connected to its COVID-19 vaccine, including services provided under the US government agreement and royalties from licencing pacts, boosted revenue to $178.8 million.

Pfizer shares surge 6% to reach all-time high mark since 1999, Here’s how

Vandana Nampoothiri — Wed, 11 Aug 2021 04:48:40 +0000

Pfizer’s share price surged 6% on Tuesday to reach a record high of $48.57. The pharmaceutical company surpassed its previous record of $47.39, which was reached in 1999.

Jeff Jonas, a portfolio manager at Gabelli Funds told Reuters, “I think they are finally getting credit for the vaccine. ” According to Jonas, investors thought of Pfizer vaccine as “a one-time cash infusion”. He also said Pfizer should be able to leverage the vaccine’s technology for use against other types of disease as well.

According to Business Insider, Pfizer partner BioNTech’s second-quarter results released on Monday show that demand for its COVID-19 vaccine will be strong into 2022 and beyond.

Pfizer’s COVID-19 vaccine has helped the company grow its revenue by 61% to $19 billion in the second quarter. That revenue could continue to grow as vaccines are approved for children, and the potential for a third booster shot is explored, Business Insider reported.

Ashtyn Evans, a healthcare analyst at Edward Jones told Reuters that Pfizer will be able to use the cash flow from the vaccine “for both internal research and development and for acquisitions to strengthen their pipeline.”

Along with Pfizers, share prices of other vaccine makers like Moderna and Novavax also increased in recent times. Shares of Moderna have soared to a valuation of nearly $200 billion and is now worth more than Merck as it sees revenue explode from its vaccine sales, Business Insider reported.

On Tuesday Novavax’s share prices were up by 11% after a COVID-19 vaccine delay last week.

Pune: Production of Covovax started at SII, shows 90.4 per cent efficacy

Aayushi Singh — Fri, 25 Jun 2021 16:12:15 +0000

The firm announced on Friday that the manufacturing of the first batch of Covovax vaccine has started at Serum Institute of India, Pune facility.

The company said that a new milestone had been reached, they began their first batch of Covovax at their facility this week in Pune.

Adar Poonawalla, CEO of The Serum Institute of India said that they were hoping to launch Novavax’s COVID-19 vaccine “Covovax” in India by September as the trials of the vaccine have been in advanced stage of completion.

Novavax announced in September 2020 about a manufacturing agreement with SII for it’s COVID-19 vaccine NVX-CoV2373. Poonawalla said that the trial of Novavax’s coronavirus vaccine in India was likely to conclude by November. He added that the pharmacy giant could apply for a vaccine license even before it’s trial concludes in the country on the basis of the global data of the trial.

On June 14, Novavax said in a statement stated that a vaccine candidate ’NVX-CoV2373’ demonstrated 100 per cent protection against the moderate and severe COVID-19 infection, the candidate showed 90.4 per cent efficacy overall, it also met the primary endpoint in its PREVENT-19 picotal Phase 3 trial.

The statement added that the study enrolled at least 29,960 candidates across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity of the vaccine.

Novavax said that the Covovax vaccine had showed 93 per cent efficacy against predominantly circulating variants of concern and the variants of interest.

SII to start clinical trials of Novavax COVID vaccine for kids in July

Aryan Jakhar — Thu, 17 Jun 2021 12:36:50 +0000

The Serum Institute of India (SII) plans to start clinical trials of the Novavax vaccine against Covid-19 for children in July, news agency ANI reported on Thursday citing people familiar with the matter. SII also hopes to introduce Covavax, which is a version of US firm Novavax’s Covid-19 vaccine candidate, in the country by September, ANI also said.

Novavax Inc, which has a vaccine manufacturing agreement with SII, said on Monday its Covid-19 vaccine candidate was highly effective with 90.4 per cent efficacy overall and also showed high efficacy against predominantly circulating variants. The vaccine demonstrated 93 per cent efficacy against predominantly circulating variants of concern and variants of interest, Novavax said.

Novavax said in a statement that the vaccine candidate, ‘NVX-CoV2373’, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate the efficacy, safety and immunogenicity of the vaccine, it added.

On Tuesday, the government said the efficacy data of the Novavax vaccine against Covid-19 is promising and encouraging and its clinical trials are in an advanced stage of completion in India. NITI Aayog member (health) VK Paul said the data available in the public domain also indicates the vaccine is safe and highly effective.

“What we are learning from the available data is that this vaccine is very safe and it is highly effective but what makes this vaccine relevant for today is the fact that this vaccine will be produced in India by Serum Institute,” he said during a press conference.

Paul said there is preparatory work already accomplished by the Serum Institute of India and that they are also conducting a bridging trial which is in advanced stages of completion.

“I am also hoping that they will also start trials on children which is of special interest to all of us. The pace of vaccination should see a renewed energy from next week onwards when we will realign our efforts, state efforts and effective scale-up at ground level are expected,” he added.

Phase 3 trial of Novavax COVID vaccine shows 90 pc efficacy

Govindraj Muttepawar — Tue, 15 Jun 2021 06:28:59 +0000

Novavax on Monday said that its COVID-19 vaccine had an overall efficacy rate of 90.4 per cent in Phase III trials. The trial was conducted among 29,960 participants across 119 sites in the US and Mexico.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 (the COVID-19 vaccine) is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.

“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines,” he added.

The protein-based vaccine saw a 93 per cent efficacy against various circulating variants of concern (VoC) and variants of interest (VoI). The vaccine had an efficacy rate of 91 per cent in high-risk populations. Against other variants that have not been designated as VoI or VoC, the Novavax vaccine had an astounding 100 per cent efficacy. Of the 14 individuals who tested positive for COVID-19 in the vaccination group, all only showed mild symptoms, the company said.

Novavax will be applying for approval in the third quarter of the year after the completion of the final phases of process qualification and assay validation. The company is expected to take the Biologics Licence Application (BLA) after the US Food and Drug Administration announced that it would be issuing no further “emergency use authorisation” (EUA) licences. The company plans to produce 100 million doses per month by the end of the third quarter and increase it to 150 million doses per month by the end of the next quarter.

The company has also tied up with the Serum Insitute of India (SII) to manufacture its vaccine in India. The Central government expects to receive around 20 crore doses of Novavax manufactured by SII by the end of 2021.

Serum Institute in talks to supply 400 million vaccine doses to Gavi-Covax programme

Devanshu Singla — Sat, 09 Jan 2021 06:20:50 +0000

Serum Institute of India is in talks to sign a deal with Gavi-Covax for supplying around 400 million doses of the COVID-19 vaccine. As per the report on Business Standard, Serum Institute didn’t wish to comment on the story.

Previously, Serum Institute had signed a deal to supply 100 million doses of each Oxford-AstraZeneca and the Novavax vaccine to Gavi-Covax programme at $3 per dose.

Serum Institute of India is the largest vaccine maker in the world (by dosages).

COVAX is an initiative supported by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI) and ‘Gavi, the Vaccine Alliance’ to ensure fair and equitable access to COVID-19 vaccines for all countries.