Novavax shares rose 23% on Thursday after the close of trading amid news of the high efficacy of its original strain and “UK” coronavirus vaccine. The company is preparing to apply for permission to use its vaccine with national regulatory authorities.
Novavax (NVAX) shares surged 22.95% on Thursday after the close of trading, if this gain continues during trading hours, it will help offset the 40.6% decline over the past month. Over the past week, Novavax shares are already up 18.7%.
American vaccine development company Novavax, based in Gaithersburg, Marylin, announced the development of its coronavirus vaccine over a year ago on January 21, 2020. At that time, Novavax shares were trading at less than $ 10 per share, their closing price on Thursday March 11, 2021 was $ 187.63, an increase in 12 months of more than 1,685%.
On Thursday, Novavax released the official research results of its COVID-19 coronavirus vaccine candidate, which has been shown to be 100% effective against serious illness and death.
During the final 3 phase of trials in the UK during a period of high prevalence of the new, more contagious so-called “British” strain of COVID-19, the Novavax vaccine was 86.3% effective in preventing infection. At the same time, the effectiveness of the Novavax vaccine in protection against the original strain of coronavirus was 96.4%.
Novavax has tested its vaccine with more than 15,000 volunteers aged 18 to 84, 27% of whom were over 65 years of age.
Novavax also conducted a randomized trial of its vaccine in South Africa, where a more dangerous strain, COVID-19, was identified, with a 55.4% efficacy among 2,665 HIV-negative adults. Among 240 medically stable HIV-positive adults, vaccine efficacy was 48.6%.
Novavax Chief Medical Officer Filip Dubovsky also noted that the vaccine is well tolerated and the rate of serious side effects is low.
Novavax previously received $ 1.6 billion from the US government to fund trials of its vaccine and supply 100 million doses. The company has not yet announced a deadline for filing applications for approvals from the US Food and Drug Administration, the FDA.
In an interview with Reuters, Dubovsky said Novavax plans to apply for a UK regulatory clearance early in the second quarter of 2021. He also said the Novavax vaccine could be approved for use in the US as early as May if US regulators decide there is enough UK data to make a decision.
Results from studies of the Novavax vaccine involving 30,000 people in the United States and Mexico are expected by early April, if the FDA expects this data, the Novavax vaccine will not appear in the US until July.
Novavax executives previously said that all of the company’s vaccine plants will be fully operational by April. Novavax plans to manufacture its vaccine at eight manufacturing sites, including the Indian Serum Institute.
Novavax CEO Stanley Erk said in an interview with Reuters that he expects the company to have tens of millions of doses in stock at the time the vaccine is approved by the FDA and ready to ship to the United States.
The Novavax vaccine requires two doses at intervals of several weeks, as do the Pfizer (PFE) and BioNTech (BNTX) and Moderna (MRNA) vaccines, which have already received FDA approval and are in widespread use.
The vaccine from Johnson & Johnson (JNJ), which received FDA clearance in late February, has the advantage of requiring only one vaccination.
As health authorities register new strains of COVID-19, vaccine manufacturers are conducting additional trials of the effectiveness of their vaccines. Analysts predict an increase in the profits of vaccine manufacturers, if the COVID-19 vaccination is annual.