Tuesday, January 18

Pfizer-BioNTech Covid Vaccine Gains Historic US Approval.


The Covid-19 vaccine made by Pfizer Inc. and BioNTech SE received full approval from US regulators, a milestone that is expected to help bolster the immunization campaign amid a renewed surge in infections.

The Food and Drug Administration (FDA) said in a statement Monday that it had approved the vaccine for the prevention of disease caused by the new coronavirus in people over 16 years of age. It will be marketed under the name Comirnaty.

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The approval is the first for a Covid vaccine in the US and comes at a crucial time as the country is caught in a wave of disease caused by the highly communicable delta variant. The Biden administration has made increasing vaccines a priority in its efforts to control the latest outbreak, and it hopes the approval will boost confidence in the vaccine among people who say they distrust its rapid development.

Many large employers, colleges and universities, and state and local governments are expected to establish vaccine requirements after approval. Following the announcement, the Pentagon said it would move forward to make vaccines mandatory for US military personnel worldwide, a Defense Department spokesman said.

The two-dose regimen was initially available in the US through an emergency authorization in December. Since then, it has become the most widely used of the three available vaccines, according to data from the Centers for Disease Control and Prevention, with more than 92 million people receiving two injections.

The vaccine remains available for 12-15 year olds, as is a third dose for certain people with compromised immune systems, under an emergency use authorization.

The designation is temporary and only lasts for the duration of the pandemic.

The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met strict FDA standards for emergency use, this FDA approval should provide greater confidence that this vaccine is safe and effective.

The approval will solidify the shot’s status as a blockbuster. Pfizer said last month that it expects the vaccine to generate $ 33.5 billion in revenue this year, placing it among the best-selling drugs of all time.

Pfizer shares rose 2.7% as of 11:56 a.m. in New York trading on Monday. BioNTech’s US deposit receipts increased 9.5%.

Other vaccines could receive approvals in the coming months. In June, Moderna Inc. said it had started an ongoing filing of its so-called Biological License Application, or BLA, for its vaccine in people 18 and older. The company has not yet completed its filing, said a person familiar with the process. Johnson & Johnson plans to apply for a BLA later this year.

Robust review
The Pfizer and BioNTech application for approval was submitted in two lots. On May 7, they shared more information about the vaccine’s effectiveness and six months of safety data, based on the data that was included in the emergency use app.

Two weeks later, the companies shared information on manufacturing processes and production facilities. The full presentation was completed in mid-July.

In total, the application was 340,000 pages long, more than three times the length of the emergency clearance submission.

Although the review process generally takes eight months, US regulators said they used “speed teams” to evaluate “an enormous amount of data.” Ultimately, the review was completed in less than half the time.

Pfizer hopes to get full approval for its vaccine in children ages 12-15 before the end of the year. For children under the age of 12, the process will take longer. Neither Moderna nor Johnson & Johnson have yet applied for full FDA clearance for the use of their injections in younger children or adolescents.

‘Pandemic of the unvaccinated’
President Joe Biden and top US health officials hope full approval will build confidence in the vaccine among unvaccinated Americans. About 3 in 10 US residents Eligible for immunization have not received a vaccine.

Peter Marks, the head of the FDA division that reviewed the approval request, said the immunization campaign has been riddled with falsehoods, such as that vaccines contain microchips or cause infertility.

“Let me be clear, these claims are simply not true,” Marks said in a briefing on Monday. “Receiving a Covid-19 vaccine can save your life.”

The FDA’s decision is likely to have the biggest impact on people who have suggested they are taking a “wait and see” approach, said Timothy Callaghan, who studies rural health at Texas A&M University.

“This approval, coupled with the spread of the delta variant, could prompt many in that group to vaccinate,” he said. However, Callaghan cautioned that the most indecisive Americans, many of whom cling to misinformation, will remain indifferent.

Ezekiel Emanuel, a medical ethicist at the University of Pennsylvania and a former adviser to Biden’s transition team, puts it another way. “The last excuse would be removed,” he said, “we have more than enough data.”

Opening the market
New York-based Pfizer and its German partner BioNTech are likely to become a more integral part of reaching out to undecided Americans, as formal approval allows companies to launch marketing campaigns.

The approval will also open the opportunity to non-government buyers, although that change in supply negotiations will not occur until next year.

Pfizer expects the US government to remain the sole distributor of vaccine doses nationwide until next April at the earliest. That means the Biden administration will continue to determine where the supply is sent, and those eligible to be vaccinated will continue to receive the regimen and subsequent boosters free of charge.

FDA Acting Director Janet Woodcock said the agency still needs to evaluate additional data before approving a third booster dose for people who are not immunosuppressed.

“We do not encourage unauthorized use,” Woodcock said at the briefing. “Usually our doctors can do this, but this is a circumstance where the vaccine is distributed under a provider agreement with the CDC and therefore the providers agree to meet certain conditions.”

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