... He said they are working on manufacturing and distributing Novavax as well as an undisclosed vaccine candidate.
... “Our colleagues in North Carolina started manufacture back in early summer and they’ve done some initial runs there and they’ve now transferred the manufacturing process to us here in Texas and we have started manufacturing that product for Novavax,” said Farrell.
... Farrell wasn’t sure when local candidates like Novavax would get FDA approval.
”Once Novavax gets approval then we’ll be ready to ship material from here,” Farell said.
Government of New Zealand for 10.7 Million Doses of COVID-19 Vaccine
... The company will work with Medsafe, New Zealand’s regulatory agency, to obtain product approvals as needed. Given the urgency of timely approval and delivery of vaccine during the pandemic, the regulatory review process may leverage review by prioritized regulatory bodies such as the U.S. Food and Drug Administration, European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the United Kingdom.
Ardern Announces New Zealand’s Largest-Ever Immunization Program
-Aims to vaccinate entire population against Covid-19 next year -Government secures vaccines from AstraZeneca, Novavax
... The government has secured two additional vaccines from pharmaceutical companies AstraZeneca Plc and Novavax Inc, and will have enough for all five million New Zealanders, Ardern said Thursday in Wellington. If proven to be safe and effective, immunization will begin with border workers and essential staff in the second quarter of 2021 followed by the general population in the second half, she said. The vaccines will be free to the public.
“This will be New Zealand’s largest immunization roll out ever,” Ardern said in a statement. “Most countries are factoring the roll out to take all of 2021 and some of 2022 to complete due to its scale and complexity, also due to production and delivery timeframes.”
Sollte Modernas Impfstoff spätestens Anfang Januar zugelassen werden, besteht kein Zweifel das der dritte zugelassene Impfstoff NVX-CoV2373 sein wird, imo!
Novavax Vaccine Will Probably Work on New Covid Strain: CEO
Dec.28 -- Novavax Inc. Chief Executive Officer Stan Erck discusses the phase 3 trial of the company's Covid-19 vaccine and says the data so far have been at or above the levels of Moderna Inc. and Pfizer Inc. He speaks with Bloomberg's Alix Steel on "Bloomberg Markets."
Banani
: Manufacturing for Novavax vaccine ramping
up in RTP as phase 3 clinical trials begin
...Meeson said that normally a clinical trial would be done with a small amount of product and "hopefully that trial would be successful." After that, he said, you'd start making lots of product to take out and treat people with.
...But they're hopeful this different process will allow them to have millions of doses ready to go out to the American people once the trial comes to a conclusion.
"Vaccines are very safe. We wouldn't be putting this into people or even testing at all if there was any hint it was not going to be safe." @Novavax president of R&D Dr. Gregory Glenn
Banani
: efficacy endpoint against the two strains
Novavax can assess shot’s efficacy on new COVID-19 variant - Cantor Fitzgerald
Weighing in on the COVID-19 vaccine candidate from Novavax (NVAX +3.4%), Cantor Fitzgerald analyst Charles Duncan says the company has an opportunity to assess the shot's efficacy against the original strain and the newly-found U.K. variant.
In December, the U.K. notified the WHO on the new strain of COVID-19 thought to be highly transmissible than its predecessors.
“We believe the study has a high [probability of success] as it will be a composite efficacy endpoint against the two strains,” Barron’s quoted the analyst saying.
In November, Novavax announced that it completed the enrollment of 15,000 participants in a pivotal Phase 3 clinical trial for the vaccine candidate conducted in the U.K. with results expected in Q1 2021.
In December, the Phase 3 study for its COVID-19 vaccine candidate started in the U.S. and Mexico. Novavax’s vaccine candidate, NVX-CoV2373, is a protein-based jab engineered from the genetic sequence of SARS-CoV-2, the virus causing COVID-19.
Noting that the vaccine is not based on messenger RNA technology, but with a more established approach,’ the article says, ‘an effective Covid- 19 vaccine that works differently from the currently authorized vaccines could help relieve supply chain pressures, and get more people vaccinated faster.’
Duncan pegs a 60% probability for the vaccine to reach a 90% efficacy rate in line with those achieved by Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX). Such a result will drive shares up 30%, he predicts.
However, Novavax has already surged over 2,500% over the past 12-month period, but Wall Street remains cheery on the stock, with five ratings on the stock outnumbering two neutral or bearish recommendations.
Baxter-Werk in Halle produziert bald im Auftrag von Biontech – später auch für Novavax
Impfstoff aus OWL ab März
Halle (WB/dpa) - Der Pharmakonzern Baxter will in seinem Werk in Halle spätestens Anfang März mit der Auftragsfertigung des Corona-Impfstoffs von Biontech beginnen. Später soll auch für das US-Unternehmen Novavax ein Vakzin in OWL hergestellt werden.
Serum Institute to stockpile Novavax vaccine candidate from around April
The Serum Institute of India, the world's biggest vaccine maker, will start stockpiling millions of doses of the Novavax coronavirus vaccine candidate starting around April, CEO Adar Poonawalla told the Reuters Next conference on Thursday.
"Upwards of 40-50 million doses per month is what we are trying to stockpile starting from April," he said.
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