Pfizer applies for COVID-19 vaccine emergency use authorization to US FDA |
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Pfizer applies for COVID-19 vaccine emergency use authorization to US FDA
Reuters,  21 November 2020
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Pfizer gave an application to US health officials for emergency use authorization oftheir COVID-19 vaccine on Friday. This is the 1st of its kind application towards a most important step providing protection against the novel coronavirus infection.

The application to the US Food and Drug Administration (FDA) was done after Pfizer and German partner BioNTech SE had reported their final trial results showing that the vaccine was 95% effective in preventing coronavirus with no major safety concerns.

Albert Bourla, Pfizer’s chief executive officer also confirmed that the application has been made in a video that was posted on the companys website on Friday. The possibility of a vaccine soon has raised hopes for the end of this ongoing pandemic that has claimed almost a quarter of a million lives in the United States and above 1.3 million deaths worldwide.

The application includes safety data on approximately 100 children 12-15 years of age. The company said that 45% of US trial participants were 56-85 years old. If the data is solid and robust then it is weeks away from the approval of a 95% effective vaccine, said Alex Azar, the US Health and Human Services secretary.

The companies are expectant that the FDA would grant the EUA by this mid-December and will initiate the shipping doses immediately. Pfizer said it is expecting to have 50 million vaccine doses ready by this year end, which is enough to protect almost 25 million people.

An FDA advisory committee is tentatively planning to meet on December 8-10 for the discussion of the vaccine. The final trial data has shown that the vaccine provides a similar level of protection in different ages and ethnicities. This is an encouraging outcome as the coronavirus disease disproportionately harms the elderly and minorities.

Out of the 170 volunteers who had contracted COVID-19 in Pfizers trial which involved more than 43,000 people, 162 volunteers received only a placebo, denoting that the vaccine was 95% effective. The US FDA had set a minimum standard for efficacy of 50%. Pfizer said that approximately 42% of global volunteers and 30% of US volunteers in the Phase 3 trial had racially and ethnically diverse backgrounds.

The next company to seek a US emergency approval for a COVID-19 vaccine is ModernaInc. Anpreliminary analysis of data from the late-stage trial has shown that the vaccine was 94.5% effective. Final outcomes with safety data are expected in the few days or weeks.

Both the Pfizer/BioNTech and Moderna vaccines are working by using a new technology to activate an immune response that is known as synthetic messenger RNA. This can be produced at a large scale quickly than traditional vaccines.

Out of lots of drug makers and research institutions to develop COVID-19 vaccines, the next late-stage evidence is expected from AstraZeneca Plc, who is working with the University of Oxford. Also, Johnson & Johnson said it is also expecting to have evidence required to get US authorization for its investigational vaccine by February 2021.

Source: ET Healthworld

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