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Novavax files for interim authorization of COVID-19 vaccine in Singapore
$Novavax (NVAX.US)$ announces its submission to the Singapore Health Sciences Authority (HSA) for interim authorization of its COVID-19 vaccine, NVX-CoV2373, under the Pandemic Special Access Route.
Shares down 1.4% premarket at $198.
The filing includes clinical data from two pivotal Phase 3 clinical trials, PREVENT-19 conducted in U.S. and Mexico; and U.K. trial including 15,000 participants.
Novavax recently received Emergency Use Authorization (EUA) for the vaccine in Philippines, and has filed for vaccine approval in South Korea.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
The EMA has also started evaluating Novavax's marketing application for its COVID-19 vaccine.
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Brandon Golden : Great job! - Singapore is a financial hub for Asia, so this is very important for their well being and the financial well being of Asia.
Geminiasianboi Brandon Golden : Their [Singapore] cases and deaths skyrocketed beginning in September, followed in October and November. Far-far higher than anytime this year! (link to Singapore dashboard, see daily and weekly) https://covid19.who.int/region/wpro/country/sg
IT farmer Brandon Golden : And Singapore is already 94% vaccinated with mostly mRNA vaccines. Cases AND deaths started to skyrocket once vaccination rate had passed 80%. Interesting, isn't it?
Restrictions have NOT been lifted (contrary what they've told the western media). Masks mandatory even outside. Until 3 days ago can only
Marvan : When are they gonna file in the US?
r8ntdxstAw Marvan : Anticipate within the next 20 days. (Already well known to happen by the end of year.) Get ready for it.
xoshi8HiuI : They might have something to hide. If they believe that they will get EUA easily, they would do it. They understand time is money.
RjqRwaUMHM : EUA is never easy, therefore the delays from Q2 to now. Still targeting this year. Let's see what happens.