Novavax vaccine shows 89% efficacy in UK trials

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Source: BBC

A new coronavirus vaccine has been shown to be 89.3% effective in large-scale UK trials.

The Novavax jab is the first to show it is effective against the new variant of the virus discovered in the UK, the BBC’s medical editor Fergus Walsh said.

The PM welcomed the “good news” and said the UK’s medicines regulator would now assess the vaccine.

The UK has secured 60 million doses of the jab, which will be made in Stockton-on-Tees.

The doses are expected to be delivered in the second half of this year, if approved for use by the Medicines and Healthcare Products Regulatory Agency (MHRA), the government said.

The UK has so far approved three coronavirus vaccines for emergency use – one from Oxford University and AstraZeneca, another by Pfizer and BioNTech, and a third from drug firm Moderna.

The Novavax jab was shown to be 89.3% effective at preventing Covid-19 in participants in its Phase 3 clinical trial in the UK, which enrolled more than 15,000 people aged between 18-84, of whom 27% were older than 65, Novavax said.

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Press release:

Categories: Vaccine

6 replies

  1. Novavax (NVAX) CEO Stanley Erck is hoping the U.S. Food and Drug Administration (FDA) will consider using the company’s U.K. data to speed up rollout of its COVID-19 vaccine, rather than waiting until later in March.

    The 89.3% efficacy rate in the U.K. is a blended result of efficacy against the original and the U.K. strain (B.1.1.7). The vaccine was 96% efficacious against the Wuhan strain and 86% efficacious against the U.K. strain, Erck told Yahoo Finance in an interview Friday.

    The company has confidence in working through the regulatory process, but Erck said he is working with the FDA to try get the U.K. data to start filing for an emergency use authorization (EUA).

    “You’re looking at way off in March to get the U.S. trial closed and then analyze the data,” Erck said.

    The company also had interesting results from its Phase 2b trial in South Africa, the source of the most concerning coronavirus strain (B.1.351). The company is working on creating either an additional shot or a booster to protect against this strain, Erck said, noting the effort to do so would not be as heavy a lift.

    “They are basically the same entity,” Erck said of the variants.

    The company has scaled up quickly in the past one year, readying itself for its first vaccine on the market — a story it shares with Moderna (MRNA) — and investing heavily in manufacturing capacity through purchases and partnerships.

    https://finance.yahoo.com/news/novavax-ceo-uk-data-should-be-used-for-quicker-us-covid-19-vaccine-rollout-145332626.html

  2. OTTAWA — Canada’s hopes of speeding up COVID-19 vaccinations brightened slightly over the weekend as regulators began work to approve a new inoculation, even as the federal government sought to head off any restrictions on vaccine shipments from Europe.

    Pharmaceutical company Novavax quietly submitted its COVID-19 vaccine to Health Canada for regulatory approval on Friday, less than two weeks after Ottawa finalized a deal with the Maryland-based company for 52 million doses of the shot.

    Because of the emergency nature of the pandemic Health Canada is accepting applications for vaccines before the final trial data is ready, allowing the review team to start pouring over the documents on an ongoing basis, rather than waiting until everything is finished.

    https://www.ctvnews.ca/health/coronavirus/novavax-submits-vaccine-for-approval-as-ottawa-seeks-eu-reassurances-on-export-rules-1.5289719

  3. TipRanks
    TipRanks
    Mon, February 1, 2021, 2:34 PM

    NVAX
    +21.80%

    More content below
    In the race to bring a coronavirus vaccine to market, Novavax (NVAX) looked like a loser — lagging rivals like Pfizer and Moderna by months. Now, all of a sudden, Novavax looks like a winner — and its stock doubled over the past two trading sessions.

    What rabbit did Novavax pull out of which hat to accomplish this?

    After close of trading Thursday, the company announced that in clinical Phase 3 trials, its NVX-CoV2373 vaccine has shown “strong efficacy” in preventing infection with COVID-19, even when “over 50%” of the cases combated were of the “now-predominant UK variant” of the disease. Furthermore, the company says that Phase 2b trials in South Africa have demonstrated “clinical efficacy” in preventing infection with the “South Africa escape variant” of the disease. Overall, NVX-CoV2373 is looking to be 89.3% effective at protecting patients against coronavirus.

    In short, said Novavax CEO Stanley C. Erck: “NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants.” In so doing, Novavax has addressed the concerns of multiple medical professionals (and patients) worrying that, no sooner had we invented vaccines to beat coronavirus, than the virus already mutated into forms against which the vaccine could not defend.

    B. Riley analyst Mayank Mamtani explained the significance of the news, calling the data both “overwhelmingly positive” and “above Street expectations.” Indeed, the 5-star analyst points out that at 96% efficacy against the original strain of coronavirus, Novavax’s vaccine appears to be the “best-in-class” vaccine. Better than Pfizer’s. Better than Moderna’s, too. (And probably way better than Sputnik V).

    In Mamtani’s view, the United Kingdom (where the Phase 3 trial was conducted and the “UK variant” is obviously a primary concern), rollout to market of Novavax’s vaccine is likely to begin within the “next few weeks.” In the US as well, the analyst is predicting rapid Emergency Use Authorization.

    This seems patently good news — good enough that Mamtani was willing to jump to the conclusion that “NVAX shares are undervalued and [even after the 3845% jump in share price, over the past 12 months, the stock] doesn’t fully reflect the potential of the underlying adjuvant platform that enables rapid creation and large-scale production of vaccine candidates.”

    Regardless of how big the orders end up coming in, explains Mamtani, Novavax’s vaccine has significant advantages over the competition, including in particular the ability to be shipped at room temperature. Furthermore, Novavax has demonstrated a facility at employing small doses and combinations with other drugs and vaccines “to remain one of the pioneers in addressing the evolving C-19 pandemic globally,” such that even as the virus mutates, Novavax’s vaccines can still target it. In fact, that’s probably the best news of all.

    Accordingly, Mamtani reiterates a Buy rating on Novavax shares and bumped the price target up from $223 to a Street high of $334. Investors could be pocketing gains of 23%, should Mamtani’s thesis play out over the coming months.

    https://finance.yahoo.com/news/novavax-stock-gets-street-high-193458982.html

  4. As recently as December, the vaccine maker Novavax appeared to once again be on the brink of failure.

    Manufacturing troubles had forced the little-known Maryland company, which in its 34-year history had never brought a vaccine to market, to delay the U.S. clinical trial of its experimental Covid-19 inoculation, jeopardizing its $1.6 billion contract with the federal government. And two Covid-19 vaccines made by its competitors were already shipping around the country, leaving some to wonder whether Novavax would ever catch up.

    But the picture has significantly improved. The company announced last week that its vaccine showed robust protection in a large British trial and also worked, although not nearly as well, in a smaller study in South Africa against a contagious new variant.

    And the scarcity of the two vaccines authorized in the United States, made by Moderna and Pfizer, seems to have made it easier for Novavax to recruit volunteers in its trial here. That speedy enrollment has put the company on track to have results this spring, with possible government authorization as early as April. If all goes right — and nothing is guaranteed — that would mean an influx of 110 million vaccine doses, enough for 55 million Americans at two doses each, by the end of June.

  5. Feb 3 (Reuters) – Europe’s drugs regulator said on Wednesday its panel is reviewing Novavax’s COVID-19 vaccine on a rolling basis, to speed up potential approvals as the region reels from surging infections due to new variations of the virus.

    The human medicines committee of the European Medicines Agency will review data from ongoing trials of the U.S.-based company’s vaccine, NVX-CoV2373, as they become available until there was enough for conditional approval, the regulator said

    https://finance.yahoo.com/news/eu-drugs-regulator-begins-rolling-170022556.html

  6. The government of Switzerland has entered into an agreement with Novavax (NVAX +7.8%) for the delivery of 5M doses of the company’s experimental COVID-19 vaccine.
    The purchase order for the COVID-19 vaccine from Moderna (MRNA +4.0%) has also been raised by 6M doses to 13.5M, according to a statement from the Swiss federal office of public health.
    An agreement has also been reached between CureVac (CVAC +6.0%) and the Swedish government to secure 5M doses of investigational COVID-19 vaccine from the German pharmaceutical company.

    https://seekingalpha.com/news/3657985-novavax-moderna-and-curevac-secure-new-covid-19-vaccine-orders-in-switzerland

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