On June 7, the US Food and Drug Administration (FDA) will hold a meeting to decide whether to approve Novavax's new crown vaccine for emergency use authorization. However, the FDA reported on Friday local time that there was a risk of heart inflammation after vaccination with Novavax's new crown vaccine. Although the company's data show that its vaccine can improve people's resistance to novel coronavirus.
Novavax is an American vaccine research and development company. Before the outbreak, the company did not have a vaccine successfully approved for listing in its 33 year history. Clinical trials failed repeatedly and it was on the verge of delisting.
During the period from December 27, 2020 to September 27, 2021, Novavax conducted experiments on nearly 30000 participants. The study found that the effectiveness of the new crown vaccine for adults was 90.4%. However, five cases of myocarditis and pericarditis were reported within more than 20 days after vaccination.
The FDA issued a long document to analyze the relevant results. Previously, it had made a similar analysis on the other three vaccines approved for use in the United States. Agence France Presse quoted the agency as saying that researchers found 6 cases of myocarditis in a group of subjects vaccinated with Novavax vaccine, while in the control group injected with placebo, there was only 1 such case. Five cases occurred within two weeks of vaccination.
The food and Drug Administration said that among the 40000 participants in the clinical trial, "multiple vaccine related cases have been found", which has raised concerns that the risk of myocarditis after vaccination with Novavax vaccine "may be higher than" other vaccines such as Pfizer or Modena.
According to the report, in fact, researchers found that there was a slight risk of myocarditis after receiving the messenger RNA vaccine from Pfizer or Modena, especially in young men and adolescent boys.
FDA warned that the risk of heart disease caused by Novavax new crown vaccine was higher than that of other vaccines. The FDA also said it had asked Novavax to mark myocarditis and pericarditis as "important identified risks" for its new crown vaccine. However, Novavax has not yet agreed to such an approach.
In addition, Novavax issued a statement saying that in some post crossover studies, the myocarditis cases found were within the expected range, and it believed that there was not enough evidence to establish a causal relationship.
"The available data from the short-term follow-up show that the symptoms of most people have been resolved, and there is no information about the potential long-term sequelae," the FDA researchers wrote The FDA noted that one patient in the placebo group also developed myocarditis during the study period.
FDA added: "based on the efficacy of the vaccine in clinical trials, due to the spread of Omicron, the vaccine is more likely to provide some meaningful protection against new coronal infections, especially for more serious diseases."
It is understood that Novax 'vaccine does not use mRNA technology. It is based on recombinant protein, just like manufacturing influenza vaccine. As a result, it is easier to transport and manage, helping to improve vaccination rates.
Affected by this news, Novavax was sold off by investors in the session last Friday, and its share price plunged by more than 20%. At the same time, due to the fierce competition in the new crown vaccine market, the market demand is also declining. Novax's share price has fallen by 86% compared with the record in February 2021. However, its performance is far inferior to that of other vaccine manufacturers. Modena fell about 26% over the same period.
Previously, according to the financial report of Novax, the company's revenue in the first quarter was US $704million, compared with us $447million in the same period of 2021, a year-on-year increase of 57.5%, less than the market expected US $845million; The net profit was USD 203million, and the net loss for the same period in 2021 was USD 223million; Diluted earnings per share was $2.56, with a loss of $3.05 for the same period in 2021.
In the first quarter, the sales volume of nvx-cov2373 products of the company's new crown vaccine was $586million. Stanley c.erck, President and CEO of Novavax pharmaceuticals, said: "with the emergence of new variants of covid-19, we have advanced our strategy and are ready to deal with the dynamic environment."
At present, the COVID-19 epidemic in the United States is spreading in the western part of the country. According to the Wall Street Journal on the 5th, people have been required to wear masks again in many places.
According to the data of the Centers for Disease Control and prevention, the western region of the United States has surpassed the northeast, becoming the region with the highest rate of new crown infection per 100000 people in the country. The center recommended that 13 counties in California with serious epidemics should be required to wear masks in public places and indoors. On the 3rd local time, San Francisco Alameda County has asked people to wear masks in public places. Nicholas moss, a health official of the county, said, "we cannot ignore these data and predict when the epidemic will end. Wearing masks again provides us with the best opportunity to reduce the impact of the long-term epidemic.".
According to the data of the US Centers for Disease Control and prevention, the US has reported an average of about 100000 new coronal cases every day in recent days, four times as many as two months ago. U.S. epidemiologists believe that this figure still greatly underestimates the real number of cases, because more and more people are using household detection devices that cannot be tracked by the public health department.