Novavax again delays seeking US approval for COVID-19 vaccine

Novavax again delays seeking US approval for COVID-19 vaccine

6/8/2021 12:03:00 AM

Novavax again delays seeking US approval for COVID-19 vaccine

Novavax on Thursday (Aug 5) again delayed its timeline for seeking US authorisation for its two-dose COVID-19 vaccine, and the company now expects to file for its emergency use in the fourth quarter of 2021. It had previously said it would seek emergency use authorisation (EUA) from the US Food and Drug Ad

Novavax on Thursday (Aug 5) again delayed its timeline for seeking US authorisation for its two-dose COVID-19 vaccine, and the company now expects to file for its emergency use in the fourth quarter of 2021.It had previously said it would seek emergency use authorisation (EUA) from the US Food and Drug Administration in the third quarter.

1,178 new COVID cases, 3 more deaths reported in Singapore 62-year-old woman among three COVID-19 deaths; 1,173 new local cases reported in Singapore 1,173 new locally transmitted Covid-19 cases in S’pore, including a record 1,038 in the community; cluster found at tuition centre

Novavax shares dropped 8.5 per cent in after-hours trading."It's a matter of getting validation work done" to demonstrate consistency in the vaccine's manufacturing process to the FDA, said Chief Executive Officer Stanley Erck, adding that other countries' regulators have been more aggressive in moving Novavax's vaccine through the authorisation process.

Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer and Johnson & Johnson. It has repeatedly delayed regulatory filings and the timeline for ramping up production as it struggled to access raw materials and equipment needed to produce the vaccine. headtopics.com

The company said it has filed for regulatory authorization of NVX-CoV2373 in India, Indonesia and the Philippines and expects to file for the World Health Organization's emergency listing for its shot this month, a prerequisite for exports to numerous countries participating in the COVAX international vaccine sharing program.

Erck told Reuters the company is on track to submit a regulatory filing in the United Kingdom in September followed within weeks by submissions in Australia and Canada.He expects Novavax to emerge as a major distributor of vaccines to lower and middle-income countries in 2021.

Separately, Novavax said a single booster shot of its vaccine given six months after an initial two-dose regimen, elicited a 4.6-fold increase in antibodies.According to Erck, the company will file a separate application with the FDA once its EUA submission is processed.

The company said it remained on track to produce 100 million doses per month in the current quarter and 150 million doses by the fourth quarter."We appear to have got past (certain) supply issues and are now being able to produce at scale," Erck said. headtopics.com

Permission to Dance? BTS sing their way through United Nations India government won't buy Pfizer, Moderna COVID-19 vaccines amid local output: Sources ‘I was burning’: Worker who survived deadly Tuas blast recalls explosion that burnt 58% of his body’s surface area

Novavax reported a net loss of US$352 million, or US$4.75 per share, for the second quarter of 2021, far higher than its net loss of US$18 million for the same period in 2020. It's second quarter revenue was US$298 million. Read more: CNA »

Permission to Dance? BTS sing their way through United Nations

NEW YORK — Fully vaccinated South Korean band BTS danced its way through the United Nations (UN) in a Monday (Sept 20) broadcast, promoting global goals tackling poverty, inequality, injustice and climate change ahead of the annual UN gathering of world leaders.

US developing plan to require foreign visitors to be vaccinated against COVID-19: OfficialWASHINGTON: The Biden administration is developing a plan to require nearly all foreign visitors to the United States to be fully vaccinated against COVID-19 as part of eventually lifting travel restrictions that bar much of the world from entering the United States, a White House official told Reuters on Wednesday 本來就應該是這樣的。

US COVID-19 cases hit six-month high, Florida grapples with surgeThe United States hit a six-month high for new COVID-19 cases with over 100,000 infections reported on Wednesday (Aug 4), according to a Reuters tally, as the Delta variant ravages areas where people did not get vaccinated. The country is reporting over 94,819 cases on a seven-day average, a five-fold incr

Telecom firm Lumen to sell some US business in US$7.5 billion dealREUTERS: Lumen Technologies said on Tuesday it would sell some of its U.S. business, to Apollo Global Management Inc in a deal valued at ...

Olympics-Athletics-'Embarrassing and ridiculous' - US men under fireTOKYO : With world records smashed and dozens of personal best times achieved on its speedy track, Tokyo's Olympic athletics programme is proving to be one of the most memorable for decades.For an ever-growing number of what is normally an all-powerful United States' men's team, however, these are fast be

Taiwan's Foxconn buys US$90.8 million wafer plant from Macronix, eyeing EV chipsTAIPEI :Foxconn said on Thursday it has bought a chip plant from Taiwan chipmaker Macronix International for TUS$2.52 billion (US$90.8 million), as the electronics giant looks to make auto chips amid its foray into the electric vehicle (EV) market.Electronics manufacturing conglomerate Foxconn, which counts g

Malaysia's AirAsia nets US$56.8 million from Fly Leasing mergerKUALA LUMPUR : Malaysia's flagship budget carrier AirAsia Group Bhd earned US$56.83 million from a merger between Fly Leasing Limited and Carlyle Aviation Partners, it said in a statement on Thursday. Carlyle in March announced it would buy Fly Leasing for an enterprise value of US$2.36 billion.Air