What does emergency use for a COVID-19 vaccine mean?

Joanna Estrada
November 21, 2020

It took 15 years to develop a vaccine for human papilloma virus, which can cause six kinds of cancer.

"We have seen tremendous uptake of that option already", Azar said yesterday.

The BioNTech/Pfizer shot and another one from United States firm Moderna have taken the lead in the race for a vaccine, after large-scale trial data this month showed their jabs were around 95 percent effective against Covid-19.

Glimpses of the Pfizer data through news releases have so far exceeded expectations: The two-dose vaccine regimen was 95 percent effective at preventing disease in clinical trials and had no major safety problems, according to the company.

The FDA did not say how long it would take to review the data on vaccine efficacy and safety, the two main criteria. "Our scientists are well-ahead of others in terms of research around vaccine development", Vardhan said while addressing a webinar organised by the FICCI FLO on "The Shifting Healthcare Paradigm During and Post-Covid" as reported by news agency PTI. Of 170 infections detected to date, only eight were among people who'd received the actual vaccine and the rest had gotten a dummy shot.

The Moderna vaccine is likely to be authorised within seven to 10 days of Pfizer receiving an emergency use authorization (EUA).

"In considering EUA requests, the agency promptly and carefully evaluates the totality of the scientific evidence that is available on the product's safety and effectiveness to determine whether the medical product may be effective for its proposed authorized uses", Hahn wrote in a statement.

Data from an advanced trial showed the vaccine protects 94% of adults over 65.

The company also said the vaccine's efficacy was consistent "across age, gender, race and ethnicity demographics". Still, FDA guidelines sought to set a high standard for a vaccine, even under emergency authorization. The companies are also submitting two months of follow-up data on 38,000 people, far more than the minimum of half the participants in their 44,000-person trial.

Researchers enrolled almost 44,000 volunteers in the study, which started in late July, to increase the odds that some would develop Covid-19 with at least one symptom, though only a fraction were needed to assess whether the shot works safely. Instead, officials indicated they were considering using expanded access protocols to allow the vaccines to be used.

If the vaccine is authorized, Pfizer, health authorities and physicians will then face the arduous tasks of making enough shots to meet demand, distributing them and convincing individuals to take the vaccine. As more doses become available, the elderly and people with chronic health conditions would be vaccinated, and eventually, the rest of the population. Faced with these encouraging results, Pifzer and BioNTech declare that they want to produce 50 million doses by the end of the year and more than a billion in a year. The more people who can experience milder symptoms and recover at home, the less burden on the health care system and the less exposure that health care workers will have to the virus, which all contributes to better control of the pandemic.

The general public could begin receiving the two-shot vaccinations in the spring or summer of 2021.

Pfizer has set up its own system in the US and certain other countries for distributing the shots. They can be stored for up to 6 months at minus-20 degrees Celsius. Federal health officials said patients would be able to receive the shots free of charge.

Other reports by Click Lancashire

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