Novavax

Positive Vaccine Data Bolster Novavax

The market value of US vaccine maker Novavax is gaining momentum again on the back of promising data the company recently provided on its combined Covid and flu vaccine data.

Baxter Said to Eye Sale of Biopharma CMO Arm

Plans by US healthcare company Baxter International to shed its biopharma contract business as it streamlines operations after a poor 2022 earnings performance are gradually taking concrete shape.

FDA Finally Greenlights Novavax Covid Vaccine

It took longer than expected, but the US Food and Drug Administration (FDA) on July 13 finally granted an Emergency Authorization (EUA) to Nuaxovid, the protein-based sCovid-19 shot developed by Novavax.

US Government Buys 3 Million Novavax Doses

The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have ordered 3.2 million doses of Novavax’s Covid-19 vaccine, even before the protein-based and adjuvanted shot has cleared the US Food and Drug Administration.

FDA Panel Recommends Approval of Nuaxovid

In a vote of 21 in favor with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the FDA approve Novavax’s Covid-19 vaccine Nuaxovid for emergency use. If the health agency agrees, it would be the fourth such shot available in the US, joining the mRNA products of Pfizer/BioNTech and Moderna and the viral vector shot of Johnson & Johnson’s pharma subsidiary Janssen.

Sluggish European Uptake for Novavax Covid Shot

European uptake of the Covid-19 vaccine made by US biotech Novavax has been slack, reports say, with little clarity as to who or what is to blame. Are delivery delays still a problem as they were early in the year or is the protein-based shot not resonating with the hard-to-reach population segments that reject mRNA vaccines as too new?

Health Canada Greenlights Novavax Covid Shot

Canadian health regulator Health Canada has approved the Novavax Covid-19 vaccine Nuvaxovid for people aged 18 years and older. It is the fifth Covid shot to be cleared for marketing in the country, after Pfizer/BioNTech’s Comirnaty, Moderna’s Spikevax, AstraZeneca’s Vaxzevria and the vaccine made by Johnson’s pharma subsidiary Janssen.

Novavax and J&J with Vaccine Delivery Delays

As wealthy countries with ample supplies of Covid-19 vaccine struggle to convince more people to get the shot, and poorer countries struggle to nail down supplies, two US vaccine makers are making negative headlines. While EU and UK approval of the Novavax vaccine was just celebrated with fanfare, that company as well as Johnson & Johnson is now said to face delivery delays.

UK Gives the Final OK for Novavax Covid Shot

February kicked off with a major publicity coup for US vaccine maker Novavax, based in the state of Maryland. Its Covid-19 vaccine was granted conditional marketing authorization in the UK, Germany’s vaccine advisory panel recommended its use and the company officially filed with the FDA for emergency use authorization.

Novavax Files for EUA as Covid Market Sees more Moves

Between the Christmas and the New Year’s bells and on both sides, the international pharmaceutical and healthcare sector continued battling the coronavirus pandemic. In one of the most watched developments – most of which took place in the US – Novavax finally fulfilled its pledge to file final data to the US Food and Drug Administration (FDA) for Emergency Use Authorization of its protein-based Covid-19 vaccine during the year’s fourth quarter.

WHO and EU Nod off on Novavax Covid Vaccine

Following a recommendation by the European Medicines Agency (EMA), the European Commission has granted conditional marketing authorization to the protein-based Covid-19 vaccine made by US biotech Novavax. It is the fifth shot to be made available in all 27 member states and the first protein-based.

Fujifilm to Expand Vaccine Production in UK

Fujifilm Diosynth Biotechnologies is investing £400 million to expand its Teesside site in northeast England, where it makes the active ingredient for the Novavax Covid-19 vaccine. The Japanese company said the expanded facilities are set to open in 2023 or early 2024, creating as many as 350 “highly skilled jobs” in contract manufacturing.

Novavax Files to EMA for Covid Vaccine Nod

The European Medicines Agency (EMA) has begun evaluating a formal application from US biotech Novavax for conditional marketing authorization of the company’s Covid-19 vaccine, now branded as Nuvaxovid. The EU’s health regulator said it will accelerate the approval process and issue an opinion “within weeks” if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine.

Novavax Files for Covid Vaccine Approval in UK

Novavax has completed the submission of real time data to the UK’s Medicines and Health Regulatory Authority for the authorization of its Covid-19 vaccine candidate. It would be the first protein-based shot to be approved by the British drugs regulator.

Japan Orders 150 Million Takeda-made Novavax Doses

Japanese drugmaker Takeda has clarified its plans to produce and distribute the Novavax Covid-19 shot in the country, if and when it is approved. After several delays, in its last announcement the US biotech said it planned to apply to the US Food and Drug Administration (FDA) for Emergency Use Authorization in this year’s fourth quarter.

Novavax Hires Two Pharma Stalwarts to Push Covid Vaccine

US biotech Novavax, in the final stage of developing its protein-based Covid-19 vaccine, NVX-CoV2373, is adding muscle in human resources before applying to the US Food and Drug Administration, along with other national and international regulators for emergency use authorization in the fourth quarter.

Novavax Again Delays EUA Filing with FDA

As it continues to grapple with documentation issues, US biotech Novavax has again altered its timeline for seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its two-dose Covid-19 vaccine. Concurrently, the US government is curbing some of the funding awarded last year by the administration of former president Donald Trump.

EU Commission Orders up to 100 million Novavax Covid Vaccine Doses

The European Commission has finalized an advance purchase agreement with Novavax covering 100 million doses of the US biotech’s protein-based Covid-19 vaccine initially, combined with an option to take an additional 100 million doses by 2023.

Novavax Again Delays Filing for Vaccine Approval

US biotech Novavax has again delayed filing for approval of its protein-based Covid-19 vaccine at least until July this year, citing issues related to an assay needed to show that its manufacturing process is consistent across different sites. CEO Stanley Erck said the company now aims to submit data to regulators in the UK, US and EU in the third quarter of 2021 rather than in the second quarter as previously planned. The vaccine is currently in a rolling review with the European Medicines Agency (EMA).

Vaccine Makers Pledge Caution on Covid Rollout

With some potential Covid-19 vaccine makers suggesting they could have a candidate ready for approval and maybe even deployment this autumn, concerns are arising that a doubting public could shun inoculation.

Vaccine Research – an Ambitious and Important Venture

U.S. Government Investment Gives Flu Vaccines a Shot in the Arm