Pfizer Inc gained emergency US authorization for its Covid-19 vaccine on Friday, completing an unprecedented scientific sprint that could eventually help bring an end to a pandemic that has killed nearly 300,000 Americans.<\/p>\n
The Food and Drug Administration\u2019s decision to authorize use of Pfizer and partner BioNTech SE\u2019s vaccine will now set in motion a complicated immunization drive that will launch across the country in coming days.<\/p>\n
Among the first to be inoculated will be health-care workers and seniors living in long-term care facilities.<\/p>\n
\u201cWith science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine\u2019s known and potential benefits clearly outweigh its known and potential risks,\u201d Peter Marks, the head of the FDA\u2019s office that oversees vaccines, said in a statement.<\/p>\n
The approval also caps a fraught political struggle that has seen President Donald Trump push drug regulators to swiftly clear a vaccine.<\/p>\n
In the final hours of the review Friday, White House chief of staff Mark Meadows suggested to FDA Commissioner Stephen Hahn that failure to clear the vaccine for use soon could cost him his job.<\/p>\n
The Pfizer-BioNTech shot is a landmark scientific achievement, a vaccine built from a breakthrough technology in a matter of months, in the face of a pandemic that has sickened millions worldwide. It has already been cleared by regulators in the UK, Canada and other countries.<\/p>\n
\u201cWe have worked tirelessly to make the impossible possible, steadfast in our belief that science will win,\u201d Pfizer chief executive officer Albert Bourla said in a statement.<\/p>\n
\u201cAs a US company, today\u2019s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic.\u201d<\/p>\n
The first doses will begin shipping throughout the country immediately, Bourla said in a video message released following the emergency-use authorization.<\/p>\n
Trump called it \u201cone of the greatest scientific accomplishments in history\u201d in a video on Twitter, saying the vaccine will save millions of lives and end the pandemic.<\/p>\n
A shot similar to Pfizer and BioNTech\u2019s made by Moderna Inc is expected to gain US clearance next week, providing the country with a potent combination for beating back the pathogen.<\/p>\n
More vaccines are also expected to be brought to market next year, expanding the arsenal doctors will have to rein in Covid-19.<\/p>\n
Pfizer\u2019s vaccine, like Moderna\u2019s, uses a new technology called messenger RNA that turns the body\u2019s own cells into vaccine-producing factories to fight the coronavirus.<\/p>\n
In a trial of almost 44,000 people, it was 95% effective at preventing symptomatic cases of Covid-19, protecting people of all ages and ethnicities. Crucially, it was able to prevent the most severe infections.<\/p>\n
Pfizer and BioNTech plan to provide clinical trial participants who received the placebo the authorized shot \u201cat scheduled timepoints in the study,\u201d the companies said in a joint-release, without elaborating on when those timepoints would be.<\/p>\n
\u201cThe vaccine option will be voluntary and will be implemented in alignment with the regulatory authorities where the trial is conducted.\u201d<\/p>\n
Allergy Issues<\/strong><\/p>\n Following a Thursday vote by an advisory panel of outside experts backing the vaccine for use in people 16 and older, the FDA was weighing how to address reports of serious allergic reactions in the UK, where the vaccine was approved earlier this month. Officials there have since told people with a history of significant allergic reactions not to get the vaccine.<\/p>\n In a fact sheet for patients, the FDA said \u201cthere is a remote chance\u201d the vaccine could cause a severe allergic reaction and told doctors in a similar document they should have medical interventions on hand to help treat such a side effect.<\/p>\n Many Americans have expressed skepticism about the vaccines being developed to fight the coronavirus. A wider campaign to convince the hesitant to get inoculated is expected in the weeks and months ahead.<\/p>\n \u201cAs a physician, I have no hesitation recommending that my parents and my patients\u2019 families receive the vaccine, and I encourage all Americans to get vaccinated in the order recommended by the CDC,\u201d said Richard Besser, the president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC. \u201cWhen my group is called, I will gladly roll up my sleeve.\u201d<\/p>\n Side effects in Pfizer\u2019s clinical trial were mild and developed more frequently in younger participants in the study, specifically those aged 55 and younger, with no signs of serious safety concerns, according to an FDA staff report on the vaccine\u2019s safety and efficacy.<\/p>\n After the second injection, fatigue and headache were the most common systemic reactions, occurring in 59% and 52% of the younger participants, compared with 51% and 39% in those over age 56.<\/p>\n Pfizer said patients in the trial did not experience serious allergic reactions.<\/p>\n It\u2019s unclear whether the vaccine is effective at preventing Covid-19\u2019s spread. It\u2019s possible the shot didn\u2019t work as well at preventing cases where people didn\u2019t have symptoms, meaning there will likely be a continued need for basic public-health measures such as wearing masks and social distancing.<\/p>\n Limited Supply<\/strong><\/p>\n Among the vaccine front-runners, the Pfizer-BioNTech shot is the only one that didn\u2019t take funding from the White House-led Operation Warp Speed program to accelerate development, manufacturing and distribution of Covid-19 shots.<\/p>\n However, the two companies have secured a $2 billion deal to supply 100 million doses to the US, with an option for 500 million more.<\/p>\n The shot requires special freezers to be kept extra cold temperatures until a few days before use, making distribution more complicated. Pfizer has developed special dry-ice containers to make it easier to store for facilities that don\u2019t have the needed equipment.<\/p>\n With initial supply very limited, the vaccine is expected to be given first to health-care workers and residents of long-term care facilities. Countries are clamoring for more doses, said Sean Marett, BioNTech\u2019s chief business and commercial officer, in an interview.<\/p>\n \u201cEverybody wants all their doses on January 2nd of next year, but that\u2019s not practical,\u201d he said in an interview. \u201cThis is a new technology, there does not exist a manufacturing network. We are building it.\u201d<\/p>\n To help increase the number of shots on hand, the US agreed to buy 100 million more doses of Moderna\u2019s vaccine on Friday, doubling its initial order. The government has an option to buy another 300 million doses of the shot.<\/p>\n
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