KDPH announces COVID-19 vaccine distribution draft plan


"To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo". Second, and equally important, the vaccine must prove your safety, with robust safety data generated from thousands of patients.

"We are operating at the speed of science", he wrote in a letter posted to the company's website.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the USA soon after the safety milestone is achieved in the third week of November", Pfizer Chief Executive Albert Bourla said, noting that he published the letter to provide greater clarity on the timeline for the vaccine.

"Each of the information in our United States program could be assessed not only by the FDA's scientists but also by an outside panel of independent experts at a publicly held assembly convened by the bureau".

"We're deeply grateful to all of the agencies and partners involved in this collaborative effort to develop a comprehensive COVID-19 vaccination plan", said Burgum. Its CEO repeatedly pointed to late October as a critical point for knowing more about its progress.

Inactivated "classic" vaccines use a virus germ that has been killed while others use a weakened or "attenuated" strain that is virulent enough to provoke antibodies but not to cause disease.

The approval will be requested through the Food and Drug Administration.

Pfizer and BioNTech's vaccine candidate, BNT162b2, is now being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide including the United States, Brazil, South Africa and Argentina.

The global death toll from COVID-19 has surpassed one.one million.

Authorization in the subsequent week of November would most likely point out the Pfizer vaccine was for provide as fellow front-runner Moderna acknowledged it would seek out the identical per week afterward, by November 25.

Pfizer and Moderna, both with funding assistance from the USA government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization. The current front-runners are Pfizer and Moderna Inc.

In any case, they are unlikely to be a good substitute for mask wearing, social distancing and other recommended behavior to curb transmission because we don't know how effective they will be.

AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States as early as October but its USA trial has been on hold since September.



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