The ongoing talks with the US FDA as cited by the chief executive Mr. Stanley Erck was focused on Novavax. The potential new entrant in the Covid-19 vaccination is directed to the submission of data ahead of the US trials.
The US clearance could see being generated mid-summer owing to the additional time taken for completion of formalities.
Novavax – The Newest Entrant In Covid-19 Vaccination In The US
The Covid-19 vaccine by Novavax Inc is awaiting clearance from the regulatory agency in the US for general usage. The authorization is in lieu of the data that is sampled from the British trials and is slated for completion in the next few weeks.
This is based on reports as confirmed by the chief executive as of 1st March 2021.
Novavax boasts of a 5.6% stake in the shares that was valuated at 226.85 dollars in the extended sector for trading.
The shares saw a whopping surge that surmounted to 2400%. Thus, standing at 9.82 dollars as of 21st of January 2020. This is when the company first declared in an announcement that it was venturing into the field of creating a vaccine against Covid-19.
The UK trial’s preliminary reports as released in January showcased the vaccine’s efficacy to be 96%. This is against the original variant of the coronavirus. The vaccine has registered to be 86% effective against the newest variant of the coronavirus that is spreading like wildfire in current times. Like the one, we saw originated in Britain a couple of weeks ago.
The manufacturing capacity of Novavax has shot up to a scale that has now progressed to tens of millions in doses. One that is stockpiled and ready to be shipped across the United States after a foreclosure on the authorization.
The amount is substantial and may cover up to a hundred million as confirmed by Mr. Erck over an interview. The vaccine as developed by Novavax has promised deliverance by the ending of the third quarter. Handing in over 110 million does to the government of the US. This is slated to be complete by the first half of July.
Coming April the production units of the Novavax vaccine shall see being fully operational. This is confirmed by a conference call with Mr. Gregory Glenn, the research chief at Novavax. This is after the initial reports of the quarterly results having been studied and evaluated. April, May, and June will be the testing months where most of the finishing and filling works shall be done depending on the approvals from the regulatory authorities.
Novavax is preparing for boosting up its production capabilities to suit the demand of preparing 150 million doses by May or June. This was confirmed earlier by Mr. Erck who elaborated on the clearance that is still several weeks away.
However once released in the market, the Novavax vaccine is sure to boost and add to the vaccine options for millions of Americans waiting for their dose of immunization.
Johnson & Johnson became the third beneficiary to win over the authorization for being used in emergencies for treating Covid-19. That came right after the sanctions of Pfizer and Moderna.
Novavax is a two-dose vaccine quite like Pfizer and Moderna. But is differentiated in terms of the ease in storing. That does not require to be frozen and can very well be stockpiled in normal refrigerator temperatures.
The Trump administration had paved the way for the Novavax vaccine by granting an award of 1.6 billion dollars to fund the research, development as well as the production of Covid-19 vaccine. February saw 30,000 subjects enrolling for trials of the Novavax vaccine.