Novavax COVID-19 Vaccine is still hopeful after frustrated on trials?

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Novavax COVID-19 Vaccine is still hopeful after frustrated on trials?

Novavax COVID-19 Vaccine is still hopeful after frustrated on trials?  Novavax, which uses subunit technology to develop a COVID-19 vaccine, is frustrated. Can it break the barrier and welcome the spring again?

Introduction:

On January 28, Novavax integrated clinical trials in the United Kingdom and South Africa and announced the efficacy of their vaccine:

• For the common strains of the new coronavirus, it showed an effective rate comparable to that of the mRNA vaccine (96%);
• For the British variant, there is still a high efficiency (86%);
• The effective rate for the variant in South Africa has been greatly reduced. The HIV-negative population has dropped to 60%, and if the HIV-positive population is included, it has even fallen below 50%.

Unlike the mRNA technology used by Moderna (MRNA) and BioNTech (BNTX), Novavax uses subunit vaccine technology. However, recently, Novavax’s vaccine development has encountered some setbacks…

Novavax, headquartered in Maryland, is a small company that has been working hard to bring their product, the promising COVID-19 vaccine, to the market for several months. The vaccine they produce is made with protein as the basic raw material.

On August 5, the company announced that they had encountered a certain setback in applying for an emergency use authorization (EUA) in the United States, which caused its stock price to plummet the next day. The U.S. government has stopped the company’s production of vaccines in the U.S. and stated that it will no longer provide any financial support for the company’s production and manufacturing; until the company can meet the strict production requirements of the U.S. Food and Drug Administration, it will not resume Its financial support, these strict production requirements include: to ensure that each batch of vaccines have the same protective effect on humans.

The incident was published in an article titled “COVID-19 vaccinemaker Novavax faces manufacturing setback” in “Science” magazine:

The company submitted a quarterly report on August 5th. They wrote in the report: “Recently, the U.S. government asked us to pay attention to the production standards set by the U.S. Food and Drug Administration. The quality of the vaccines we make must be consistent with them. The requirements are consistent.” As mentioned above, the U.S. government once again emphasized that they will not fund any funds produced by this company in the U.S. until the vaccines they manufacture actually meet the specified standards.

On August 6, Amy Speak, a company spokesperson, wrote in an email to Science Insider: “It will only take a while to meet the testing standards of the US Food and Drug Administration. This interaction is also part of the normal business process. We will continue to work with the U.S. Food and Drug Administration and the U.S. government to complete the emergency use authorization application for our products with the highest efficiency.”

In June of this year, Novavax conducted a large-scale trial in North America to prove that the vaccines they produce have almost the same efficacy as mRNA vaccines. They are effective for 90% of patients with symptomatic COVID-19 disease and 100% for patients with moderate and severe COVID-19 disease. Novavax has been working hard to solve the production problems they are facing. They said in June this year that they plan to submit an emergency use authorization application to the U.S. Food and Drug Administration in the third quarter. On August 5, the company postponed this plan to the fourth quarter of this year. According to the New York Times, an anonymous Biden government source said that it is not yet clear whether the vaccine produced by Novavax will eventually be authorized in the United States, nor is it sure when it will be authorized in the United States. The United States has provided the company with $1.75 billion in funding for the development and production of vaccines.

Novavax’s contractors produce vaccines in North Carolina and Texas. Despite their setbacks in the United States, they are still advancing the production of vaccines in other countries. The company also announced on August 5 that they had submitted emergency use authorization applications in India, the Philippines, and Indonesia with their partner, the Serum Institute of India. This is the first time that Novavax has submitted such an application; they are also expected to submit an emergency use authorization application to the World Health Organization this month. If the World Health Organization passes their application, it means that they have received permission to export products to many countries. prerequisites.

Novavax’s spokesperson, Speak, also wrote in the report: “The production network in the United States is separate from the production network that produces vaccines in other parts of the world. Therefore, although our application has been rejected at this stage, it will not be right. We have an impact on the supply of vaccines in other regions.”

Novavax has agreed to supply more than 1 billion doses of vaccine to countries around the world, which also includes providing 350 million doses of vaccine to poorer countries through the use of the COVID-19 vaccine implementation plan. The company also finalized a pre-purchase agreement with the European Union on August 4 for up to 200 million doses. They said they will complete emergency use authorization applications in the European Union and the United Kingdom in the third quarter.

On August 6, Novavax’s stock price fell 20% to $190. However, some stock analysts disagree with the news of the US manufacturing industry. The short-sightedness of these analysts in the US tends to overlook the quality of vaccine research and development and the strong and urgent global market demand for vaccines.

Charles Duncan, an analyst at Cantor Fitzgerald Co., Ltd., wrote in a report to investors on August 6: “We believe that Novavax already has the analysis data they need, because they have started now. The procedures submitted to various regulatory agencies should have similar production requirements and indicators to the U.S. Food and Drug Administration.

Mayank Mamtani of B. Riley Securities said: “The news of the US ban on the production of Novavax vaccine is not so important in this situation, because Novavax vaccine has strong and extensive market demand, and there are also some in the market. A clear regulatory path.”

Mamtani predicts: Novavax vaccine, as the currently authorized vaccine booster, will play an important role in the United States and will be widely welcomed by the American people. Novavax also announced on August 5 the results of a clinical study of their self-made vaccine booster. This result showed that the neutralizing antibody level of the population who received the third injection will increase four times than before.

Although Novavax has not fully approved the US government for vaccine production, it is believed that their strength and the booster needles they produce are highly protective, and hope that this vaccine can benefit more people in the near future.

(source:internet, reference only)

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Important Note: The information provided is for informational purposes only and should not be considered as medical advice.