Today the Food and Drug Administration (FDA) announced the approval of the Pfizer-BioNTech vaccine to now authorized for use for those aged 12-15.
In December, the two-dose vaccine was given approval to be administered to anyone 16 and up.
Canada is the only other country to allow younger teenagers to be administered the Pfizer vaccine. It’s authorization was on May 5th.
Business Insider notes that immunization has been going down since early, a peak of 1.9 million doses administered a day, to roughly 830,000.
Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.
Dr. Janet Woodcock. The acting commissioner of the FDA, said in a statement.
Pfizer’s clinical study enrolled over 2,200 children aged 12-15. Half got the real shot while the other half received a placebo. 18 Covid cases recorded, but all were in the placebo group. The side effects noted were those similar to those aged 16-25.
According to Business Insider, Pfizer hopes to have data collected from their tests involving children aged 2-11. They should see the results by September. Pfizer should know by November the data for those aged 6 months to 2 years-old.
Durable Revenue Stream
The following report is from AFP:
Pfizer sharply increased its 2021 profit projections on [May 4th], citing much higher Covid-19 vaccine sales which are on track to provide a “durable” revenue stream in the wake of the pandemic.
The drugmaker reported a jump in first-quarter profits based on surging revenues, with nearly one-fourth of sales coming from Covid-19 vaccines.
With German partner BioNTech, the pharma giant is ramping up vaccine production and now estimates 2021 revenues of $26 billion from the vaccine, up from the $15 billion projected in February.
But the surging profits have drawn criticism as governments face pressure to step in to ensure vaccines are provided to underserved countries.
Pfizer, which says it is on the cusp of winning US approval for individuals 12 to 15 years old to receive its vaccine, is holding talks with “basically all governments of the world” about providing booster shots through 2024, Chief Executive Albert Bourla told analysts on a conference call Tuesday.
The company is studying the efficacy of giving the jabs six or more months after the second vaccine dose, and developing doses that could be stored at standard refrigerated temperature for up to 10 weeks.
Bourla expects “durable demand” for Covid-19 vaccines, similar to that of the flu vaccine.
It is our hope that the Pfizer-BioNTech vaccine will continue to have a global impact by helping to get the devastating pandemic under control and helping economies around the world not only open, but stay open.
Albert Bourla
That would create “a scenario in which Pfizer can continue to be both a leader and a beneficiary,” he said.
Pfizer has won wide praise for its technological prowess in developing a game-changing vaccine in record time. However, critics called the profits troubling given the divide in vaccine availability between rich and poor countries.
World Health Organization chief Tedros Adhanom Ghebreyesus last month decried a “shocking imbalance in the global distribution of vaccines” and called for efforts to fortify the WHO’s Covax programs, which aims to ensure that poorer nations can access the shots.
India and South Africa are leading an effort in the World Trade Organization to waive intellectual property and patent rules, at least temporarily, which would open the door to broader production of vaccines at a time when the virus is causing mass misery in India and some other countries.
President Joe Biden said Tuesday he had not made a decision on whether to support a vaccine waiver, but that the United States was moving “as quickly as we can” to export doses.
Biden also said he was ready to “immediately” begin vaccinations for 12 to 15-year-olds as soon as Pfizer’s Covid shot is approved by regulators for the age group.
Additional Supply
Pfizer reported net income of $4.9 billion, up 45% from the same period of the prior year.
Revenues also jumped 45% to $14.6 billion, including $3.5 billion in Covid-19 vaccine sales.
The results include the lift from Covid-19 vaccines, which generated profit margins of “high-20s,” implying around $900 million in profits in the most recent quarter.
As of May 3, Pfizer and BioNTech have shipped about 430 million doses of the vaccine to 91 countries around the world.
The company has reached an agreement to provide up to 40 million doses for Covax, a globally-pooled coronavirus vaccine procurement effort aimed at providing vaccines to low- and middle-income economies.
However, the company on Tuesday pointed to a series of deals to expand offerings in richer countries, including the United States, the European Union, Canada and Israel.
Criticism Of Profits
Pfizer has defended its approach to vaccine pricing, saying it has moderated pricing through a “pandemic phase” that could last into 2022 at levels “to encourage broad access.”
The company said it is charging $19.50 per vaccine dose in the United States, but has not disclosed its US profit margin.
Zain Rizvi, a law and policy researcher at progressive Public Citizen advocacy group, said Pfizer’s rising profits showed the need for governments to take action to save lives.
Pfizer is cashing in on the crisis and hoarding technology, even as billions of people around the world go without a vaccine.
Pfizer’s profiteering shows the urgent need for governments to step-in. Governments should require Pfizer to share technology with manufacturers around the world to help ramp up global production.
Rizvi said in an email to AFP.
The company is building more capacity and expects to manufacture at least three billion doses in 2022, up from 2.5 billion now expected in 2021. In February, Pfizer said it expected to produce up to two billion doses in 2021.
Pfizer shares rose 0.3% to $39.95.
AUTHOR COMMENTARY
[9] But they that will be rich fall into temptation and a snare, and into many foolish and hurtful lusts, which drown men in destruction and perdition. [10] For the love of money is the root of all evil: which while some coveted after, they have erred from the faith, and pierced themselves through with many sorrows. 1 Timothy 6:9-10
A feast is made for laughter, and wine maketh merry: but money answereth all things.
Ecclesiastes 10:19
When in doubt, just follow the money trail and you’ll get the answer every time. Of course, Pfizer, and others, will be offering boosters shots for years to come: it means billions and billions of dollars. Of course, WinePress readers understand that there are other implications for yearly and seemingly endless vaccines, but at the end of the day, the King James Bible has it right: it’s all about the love of money.
Additionally, knowing what we know about the vaccines, prepare for waves of youth to become sick for “no reason” and to see an even drastic slowdown in births in the older generations for the years to come.
Pfizer Says The Unvaccinated Can Be Exposed To The Vaccine. Affects Reproductive Systems
Pfizer And Moderna Vaccines Also Shown To Produce Blood Clots
Pregnant Women Now Urged To Get The Covid Vaccine
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Just wait until the FDA gives a full approval (fully licensed vaccine) for Pfizer. It will only get worse from there. Think about it. Once Pfizer’s vaccine becomes a licensed vaccine, it will be easier for state governments and local municipalities to mandate this poison to the masses. We just have to keep our eyes open and be alert about what’s going on.