The Food and Drug Administration (FDA) authorized updated COVID booster shots on Wednesday created to specifically target subvariants of Omicron.
The FDA shared the approval in a Wednesday announcement that amended the emergency use authorizations for both Pfizer/BioNTech and Moderna&#8217;s boosters.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert Califf said in the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use" target="_blank" rel="noopener">statement</a>. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
Pfizer&#8217;s booster will be made available for those 12 years old and older. Moderna&#8217;s approval is for those 18 years old and above.
The boosters include the components of the original COVID vaccine along with an mRNA component to target the BA.4 and BA.5 subvariants of Omicron.
The most recent <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank" rel="noopener">data</a> provided by the CDC reveals that the BA.5 variant is responsible for 88.7% of all new cases between August 21 and August 27. The BA.4 variant included an additional 3.6% of new cases.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” <a href="https://www.businesswire.com/news/home/20220822005376/en/Pfizer-and-BioNTech-Submit-Application-to-U.S.-FDA-for-Emergency-Use-Authorization-of-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine" target="_blank" rel="noopener">said</a> Albert Bourla, chairman and CEO of Pfizer.
“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” he added.
For both booster shots, individuals are eligible “if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine,” according to the FDA.
A committee from Centers for Disease Control and Prevention is expected to approve the final step in the process this week before the new vaccine boosters begin distribution later this month.
Some health professionals are concerned regarding the new FDA approval, however, as <a href="https://www.dailywire.com/news/report-covid-boosters-could-be-authorized-for-use-before-human-testing-is-completed" target="_blank" rel="noopener">testing in humans</a> has not yet been completed.
“I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data,” Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, <a href="https://www.wsj.com/articles/latest-covid-boosters-are-set-to-roll-out-before-human-testing-is-completed-11661679003" target="_blank" rel="noopener">told</a> the Wall Street Journal in a report published on Sunday.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the news release that much care has been given regarding the safety of those taking the new boosters.
“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” he stated.

COVID vaccine

FDA Authorizes Pfizer and Moderna’s Updated COVID Boosters

FDA Authorizes Pfizer and Moderna’s Updated COVID-19 Boosters

COVID-19 Vaccine

Moderna

Pfizer

Biopharmaceutical giant <a href="https://www.dailywire.com/topic/moderna" target="_blank" rel="noopener">Moderna</a> is filing a lawsuit against <a href="https://www.dailywire.com/topic/pfizer" target="_blank" rel="noopener">Pfizer</a>-BioNTech in U.S. and German courts on Friday, alleging patent infringements in the development of its mRNA-based <a href="https://www.dailywire.com/topic/covid">COVID</a> vaccine.
Pfizer&#8217;s vaccine, now marketed as Comirnaty, was the first COVID vaccine approved on an emergency basis in the U.S., and in nearly two years since its approval, has been given hundreds of millions of times. But the other mRNA vaccine, which was authorized in the U.S. several weeks later, was based on the same technology and Pfizer didn&#8217;t have the right to use it, Moderna argues.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” said Stéphane Bancel, chief executive officer of Moderna. “This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck.”
“As we work to combat health challenges moving forward, Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer,” he said.
Pfizer said in a statement Friday morning that it was surprised by the lawsuit.
&#8220;Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,&#8221; the company said. &#8220;We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.&#8221;
Moderna says it does not want Pfizer&#8217;s vaccine removed from use, and would consider a &#8220;reasonable license&#8221; should its competitors want to use the vaccine in other markets, particularly in lower-income countries. They are also not seeking damages for the vaccine&#8217;s use in lower-income countries. But in other wealthier countries, Moderna is looking for compensation.
&#8220;Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty®&#8217;s ongoing use of Moderna&#8217;s patented technologies,&#8221; said Moderna&#8217;s chief legal officer Shannon Thyme Klinger. &#8220;Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.&#8221;
This is a developing story; refresh the page for updates.

GERMANY-HEALTH-VIRUS-VACCINE

Moderna Suing Pfizer Over COVID Vaccine

Moderna Suing Pfizer Over Its COVID Vaccine

COVID-19

Pfizer&#8217;s COVID pill reportedly offered no measurable benefit for adults 40 to 65, according to a study published on Wednesday.
The <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2204919" target="_blank" rel="noopener">Israeli study</a> was conducted among 109,000 patients who were 40 years old or older.
“Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not,” the study published in the New England Journal of Medicine concluded. “No evidence of benefit was found in younger adults.”
The research affirmed the benefits of Paxlovid among certain older adults but showed little difference among middle-aged adults who received the treatment.
The conclusion was based on the results of the study that found the rate of hospitalization due to COVID for 40-64-year olds was “15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients.”
Under an emergency use authorization order, the U.S. Food and Drug Administration authorized the use of Paxlovid to treat the coronavirus in December for adults and children 12 and older who are considered at high risk due to conditions like obesity, diabetes, and heart disease.
The FDA&#8217;s decision was based on a Pfizer study of patients who were unvaccinated or untreated for prior coronavirus infection.
The Associated Press <a href="https://www.usatoday.com/story/news/health/2022/08/24/paxlovid-pfizer-covid-pill-benefits-adults/7889907001/" target="_blank" rel="noopener">reported</a> that 3.9 million prescriptions for the drug have been filled since it was authorized late last year. The treatment includes three pills taken twice daily for five days.
Pfizer CEO Albert Bourla <a href="https://www.dailywire.com/news/quadruple-vaccinated-pfizer-ceo-tests-positive-for-covid" target="_blank" rel="noopener">noted</a> that he was personally using Paxlovid after testing positive for the coronavirus earlier this month. President Joe Biden also reportedly used Paxlovid after he tested positive for COVID.
Biden tested negative days later but then quickly tested positive again in a “rebound” case. First Lady Jill Biden shared a similar rebound positive test on Wednesday.
“After testing negative on Tuesday, just now, the first lady has tested positive for COVID-19 by antigen testing. This represents a ‘rebound’ positivity,&#8217;” the first lady&#8217;s deputy communications director, Kelsey Donohue, said in a statement.
“The first lady has experienced no reemergence of symptoms, and will remain in Delaware where she has reinitiated isolation procedures. The White House Medical Unit has conducted contact tracing and close contacts have been notified,” she added.
In addition to Paxlovid, Pfizer and BioNTech <a href="https://www.dailywire.com/news/pfizer-requests-fda-authorization-for-omicron-covid-booster" target="_blank" rel="noopener">requested</a> on Monday that the FDA grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant.
The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Bourla <a href="https://www.businesswire.com/news/home/20220822005376/en/Pfizer-and-BioNTech-Submit-Application-to-U.S.-FDA-for-Emergency-Use-Authorization-of-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine" target="_blank" rel="noopener">said</a>. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”

COVID pill

Study: Pfizer’s Paxlovid COVID Pill Showed No Measurable Benefit In Adults 40 To 65

<a href="https://www.dailywire.com/topic/pfizer">Pfizer</a> and BioNTech have requested that the <a href="https://www.dailywire.com/topic/fda">Food and Drug Administration</a> (FDA) grant an emergency use authorization for its <a href="https://www.dailywire.com/topic/covid-19">COVID</a> <a href="https://www.dailywire.com/topic/covid-19-vaccine">vaccine</a> adapted to the BA.4/BA.5 versions of the Omicron variant.
The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” <a href="https://www.businesswire.com/news/home/20220822005376/en/Pfizer-and-BioNTech-Submit-Application-to-U.S.-FDA-for-Emergency-Use-Authorization-of-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine" target="_blank" rel="noopener">said</a> Albert Bourla, Chairman and CEO of Pfizer. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.&#8221;
Ugur Sahin, CEO and co-founder of BioNTech, noted that the updated vaccines would quickly target the most dominant current strain of the coronavirus.
“Given the ongoing evolution of SARS-CoV-2 and its variants, it&#8217;s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” Sahin said in the statement. “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”
The updated vaccine contains mRNA of the original SARS-CoV-2 spike protein found in the current vaccine together with mRNA spike protein for the Omicron BA.4/BA.5 variant.
The FDA previously authorized the Pfizer/BioNTech vaccine for active immunization in adults to prevent COVID in 2019 under the Emergency Use Authorization (EUA). Later versions have been approved for younger individuals, including a recent three-dose series available to children as young as six months old.
While COVID case numbers have decreased recently across the nation, officials are recording more than 5,500 hospitalizations per day, <a href="https://covid.cdc.gov/covid-data-tracker/#datatracker-home">according</a> to the Centers for Disease Control and Prevention (CDC). On Sunday, more than 93,000 positive COVID tests were reported nationwide.
The most recent <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank" rel="noopener">data</a> provided by the CDC reveals that the BA.5 variant is responsible for 88.9% of all new cases between August 14 and August 20. The BA.4 variant included an additional 4.3% of new cases.
Several well-known Americans have tested positive despite being fully vaccinated and receiving booster shots. Both President <a href="https://www.dailywire.com/news/president-joe-biden-tests-positive-for-covid-again-will-return-to-isolation">Joe Biden</a> and First Lady <a href="https://www.dailywire.com/news/first-lady-jill-biden-has-covid">Jill Biden</a> tested positive in recent weeks.
The first lady tested positive on August 16, leading to added precautions for the president.
“The President tested negative for COVID this morning on an antigen test,” the White House press secretary <a href="https://twitter.com/PressSec/status/1559535345607360513" target="_blank" rel="noopener">tweeted</a> at the time. “Consistent with CDC guidance because he is a close contact of the First Lady, he will mask for 10 days when indoors and in close proximity to others. We will also increase the President’s testing cadence and report those results.”
Vice President <a href="https://www.dailywire.com/news/vice-president-kamala-harris-tests-positive-for-covid-19">Kamala Harris</a> and Second Gentleman <a href="https://www.npr.org/2022/03/15/1086790648/second-gentleman-doug-emhoff-tests-positive-for-covid-19">Douglas Emhoff</a> also tested positive for the coronavirus earlier this year. Other leading officials, including House Speaker <a href="https://www.dailywire.com/news/breaking-pelosi-tests-positive-for-coronavirus-day-after-attending-event-with-biden">Nancy Pelosi</a> (D-CA), have also tested positive despite being vaccinated.

Pfizer Requests FDA Authorization For Omicron COVID Booster

COVID

Omicron Variant

The <a href="http://dailywire.com/topic/biden-administration" target="_blank" rel="noopener">Biden administration</a> plans to stop paying for COVID <a href="https://www.dailywire.com/topic/covid-19-vaccine" target="_blank" rel="noopener">vaccines</a> and will begin shifting costs toward the <a href="https://www.dailywire.com/topic/health-care" target="_blank" rel="noopener">marketplace</a>, according to a Thursday report from The Wall Street Journal.
The Department of Health and Human Services will hold a planning session at the end of the month with pharmaceutical companies and state health departments to chart the transition, according to the outlet. The move could result in higher profits for <a href="https://www.dailywire.com/topic/pfizer" target="_blank" rel="noopener">Pfizer</a> and <a href="https://www.dailywire.com/topic/moderna" target="_blank" rel="noopener">Moderna</a>, which, along with other pharmaceutical companies, have earned more than $79 billion in global sales from COVID shots and treatments.
“We’ve known at some point we’d need to move over into the commercial market, and we’re approaching that time now,” Health and Human Services Assistant Secretary Dawn O’Connell <a href="https://www.wsj.com/articles/biden-administration-plans-for-end-of-covid-19-shot-treatment-coverage-11660838418?mod=hp_lead_pos6">told</a> The Journal. “We don’t want to do it by fiat.”
Because a shift to the marketplace will lead to insurers negotiating with manufacturers to determine prices, costs for COVID treatments will likely increase as insurance premiums rise. Meanwhile, roughly 31.6 million Americans do not have health insurance, according to the <a href="https://www.cdc.gov/nchs/data/nhsr/nhsr169.pdf">Centers for Disease Control and Prevention</a>.
The White House <a href="https://www.dailywire.com/news/this-is-science-pelosi-says-22-5-billion-in-extra-covid-money-is-absolutely-necessary">requested</a> $22.5 billion in new funds for COVID treatments in March. Office of Management and Budget Acting Director Shalanda Young <a href="https://www.documentcloud.org/documents/21417654-covid-letter_pelosi-31521">contended</a> in a letter to House Speaker Nancy Pelosi (D-CA) that a lack of funding would leave the nation “unequipped to deal with a future surge,” especially with regard to variant-specific booster shots.
Republicans, however, noted that billions of dollars from past stimulus packages remained unspent. “The American people need an accounting on how much is left,” Sen. Richard Shelby (R-AL) <a href="https://thehill.com/homenews/senate/596726-senate-republicans-oppose-bidens-225-billion-covid-relief-request/">argued</a>. “Let’s spend that first before we start borrowing more.”
The report comes days after President Joe Biden lambasted Republican lawmakers for voting against provisions in the Inflation Reduction Act meant to reduce certain medical costs.
“Every single Republican in Congress voted against this bill. Every single Republican in Congress voted against lowering prescription drug prices, against lowering healthcare costs, against a fairer tax system,” Biden <a href="https://www.whitehouse.gov/briefing-room/speeches-remarks/2022/08/16/remarks-by-president-biden-at-signing-of-h-r-5376-the-inflation-reduction-act-of-2022/">said</a> at a Tuesday bill signing. “Every single Republican — every single one — voted against tackling the climate crisis, against lowering our energy costs, against creating good-paying jobs.”
Biden likewise <a href="https://www.dailywire.com/news/biden-takes-credit-for-hearing-aids-made-available-over-the-counter-the-law-that-made-it-happen-was-signed-under-trump">took credit</a> for a law passed under President Donald Trump that made hearing aids available over the counter.
“For millions of Americans, hearing aids and the doctor’s visit to get them prescribed are too expensive,” Biden said in a statement. “In the executive order I issued last year to increase competition in key industries and lower costs, I called on the FDA to finally make hearing aids available over the counter.”
The new policy, however, was initially crafted by the 2017 Over-the-Counter Hearing Aid Act and implemented after the Food and Drug Administration issued a final rule on the legislation.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” Health and Human Services Secretary Xavier Becerra added. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Joe Biden

Days After Biden Pinned Drug Costs On Republicans, White House Will Stop Paying For COVID Treatments, Report Says

Biden Administration To Stop Paying For COVID Treatments, Will Pass Costs To Consumers

Biden Administration

Health Care

Pfizer CEO Albert Bourla announced Monday that he has tested positive for COVID despite receiving four doses of his company&#8217;s vaccine.
Bourla shared the news in a Twitter post on Monday morning and in a <a href="https://www.pfizer.com/news/announcements/statement-pfizer-chairman-and-ceo-albert-bourla-testing-positive-covid-19" target="_blank" rel="noopener">statement</a> on Pfizer&#8217;s website.
&#8220;I would like to let you know that I have tested positive for #COVID19. I am thankful to have received four doses of the Pfizer-BioNTech vaccine, and I am feeling well while experiencing very mild symptoms,&#8221; Bourla tweeted. &#8220;I am isolating and have started a course of Paxlovid.&#8221;
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
I would like to let you know that I have tested positive for <a href="https://twitter.com/hashtag/COVID19?src=hash&amp;ref_src=twsrc%5Etfw">#COVID19</a>. I am thankful to have received four doses of the Pfizer-BioNTech vaccine, and I am feeling well while experiencing very mild symptoms. I am isolating and have started a course of Paxlovid.
&mdash; Albert Bourla (@AlbertBourla) <a href="https://twitter.com/AlbertBourla/status/1559145992594784256?ref_src=twsrc%5Etfw">August 15, 2022</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
Despite Bourla&#8217;s positive test, the Pfizer leader claimed he looked forward to a quick recovery.
&#8220;We have come so far in our efforts to battle this disease that I am confident I will have a speedy recovery,&#8221; he shared in another post. &#8220;I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world.&#8221;
Pfizer&#8217;s vaccine was the first approved by the Food and Drug Administration for use in the U.S. in December 2020. It has since been approved for Americans 16 years of age and older, as well as for children as young as six months.
The pharmaceutical company has also marketed an authorized booster shot and has most recently been working on updated vaccines to <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-omicron-adapted-covid-19">fight against the Omicron variant</a> that Pfizer expects to release for public usage later in the year.
Pfizer&#8217;s longer statement announcing Bourla&#8217;s positive case included additional details regarding Paxlovid. The FDA granted emergency authorization in December to treat mild to moderate COVID for adults and children 12 and up who meet certain conditions.
President Joe Biden also used Paxlovid when he tested positive for COVID in July. He was also vaccinated and had received two booster shots.
The president experienced four days of consecutive negative tests but <a href="https://www.dailywire.com/news/president-joe-biden-tests-positive-for-covid-again-will-return-to-isolation" target="_blank" rel="noopener">tested positive again</a> on the fifth day in what was called a rebound case of the virus.
Biden later tested negative and has ended his quarantine, since traveling to his Delaware beach house and visiting flood victims in eastern Kentucky.
Dr. Anthony Fauci also tested positive for the coronavirus earlier this summer and was treated with Paxlovid. <a href="https://www.nih.gov/news-events/news-releases/niaid-director-fauci-tests-positive-covid-19">According</a> to a statement from the National Institutes for Health, he is fully vaccinated and has been boosted twice.
The uptick in cases in recent weeks also led Fauci to <a href="https://www.dailywire.com/news/fauci-again-urges-americans-to-wear-masks-indoors-in-group-settings">advise Americans to mask up</a> while indoors regardless of vaccination status.
While not advocating for required mandates, Fauci said during an MSBNC <a href="https://youtu.be/mo1DwGy4c_M" target="_blank" rel="noopener">interview</a> last month &#8220;when you’re in an area where you have a high dynamic of infection, and we’re not talking about mandating anything, but we’re saying recommending people when they are in indoor congregate settings to wear a mask.”

Albert Bourla

Quadruple-Vaccinated Pfizer CEO Tests Positive For COVID

Pandemic

A senior <a href="https://www.dailywire.com/topic/biden-administration">Biden administration</a> adviser has been told that she will need to recuse herself from consulting on a number of high profile policy issues because of her work representing major entities like <a href="https://www.dailywire.com/topic/pfizer">Pfizer</a> and the American Clean Energy Corporation.
CNBC <a href="https://www.cnbc.com/2022/08/12/biden-senior-advisor-anita-dunn-has-to-divest-investment-portfolio-to-avoid-conflict.html">reported</a> this week that Anita Dunn, who joined the Biden administration in May as a senior adviser will also need to divest from a large investment portfolio, estimated to be valued at between $16-$48 million after the release of her financial <a href="https://fm.cnbc.com/applications/cnbc.com/resources/editorialfiles/2022/08/11/AnitaDunn278.pdf">disclosures</a>.
The move to recuse herself from certain policy issues and divest from her investment portfolio comes after warnings from lawyers that her portfolio and corporate ties could constitute a conflict of interest.
The filings reveal that Dunn has worked for major entities like AT&amp;T, Micron, the American Clean Power Association, Lyft, Pfizer, Reddit, and Salesforce. The filing also reveals work for the Ford Foundation, Valerie Biden Owens, and the Center for American Progress.
The investment portfolio, held in conjunction with her husband and former Obama administration lawyer Bob Bauer, has a number of individual stocks in brokerage accounts, and corporate and municipal bonds.
“The ethics rules require White House officials to recuse from matters that conflict with their financial interests. When officials have a large scope of duties and an even larger stock portfolio, sunlight is the best disinfectant,” said Kedric Payne of the Campaign Legal Center.
Two of the entities, the American Clean Power Association and Pfizer, have been linked to contentious Biden administration policies.
The American Clean Power Association <a href="https://cleanpower.org/">describes</a> itself as “the leading federation of renewable energy companies expediting the advancement of clean energy as the dominant power source in America.” It <a href="https://cleanpower.org/news/acp-applauds-president-bidens-bold-action-to-reinvigorate-the-domestic-solar-industry/">has</a> often praised Biden for his stances on environmental issues.
Most recently, its CEO Heather Zichal applauded the passage of the Democrats’ “Inflation Reduction Act,” which Biden is expected to sign. She <a href="https://cleanpower.org/news/acp-ceo-heather-zichal-statement-on-house-passage-of-historic-inflation-reduction-act/">said</a> the bill &#8220;marks the point in time when the US decided to: get serious about climate change.”
Pfizer, a pharmaceutical company responsible for one of the COVID vaccines, has also been impacted by Biden admin policies, as the president has strongly pushed for vaccine mandates for private businesses and the military.
Former Office of Government Ethics head Walter Shaub told CNBC that Dunn needed to either divest from the companies or recuse herself from issues pertaining to companies in her stock portfolio.
Initially, Dunn had avoided filing the disclosure when she worked in the Biden administration previously due to her role only as a temporary adviser. The Intercept <a href="https://theintercept.com/2021/05/04/anita-dunn-ethics-disclosure-biden-skdk/">reported</a> in May that, because of this loophole, she had not been subject to the same scrutiny as others in the administration.
The White House has said that Dunn will recuse herself from issues pertaining to her previous work and divest from her investment portfolio.

Presidential Advisor Anita Dunn Meets With Democrats On Capitol Hill

Top Biden Adviser Forced To Recuse Herself From Consulting On Key Issues After Pfizer, Green Energy Ties Revealed

Biden Adviser Forced To Recuse Herself From Consulting On Key Issues After Pfizer, Green Energy Ties Revealed

Energy

Stock Market

SARS-CoV-2, the virus that causes COVID, has been morphing to stay alive &#8212; and there are now at least 11 variants and subvariants, <a href="https://disasterphilanthropy.org/disasters/covid-19-coronavirus/?gclid=CjwKCAjwiJqWBhBdEiwAtESPaNf0ZqeKZWrJoH0C64R-UaUTlCl2rTKruA5CbuOYAsNJaXlfu0RPSxoC2soQAvD_BwE">according</a> to one health site.
Scientists have noted that various vaccines out there &#8212; all created to battle the original strain &#8212; are less effective against newer variants.
&#8220;While two doses of an mRNA COVID-19 vaccine were 85% effective in preventing hospital admission for infection with the Alpha and Delta variants of SARS-CoV-2, they were only 65% effective in preventing hospitalization following an Omicron infection,&#8221; Medical News Today <a href="https://www.medicalnewstoday.com/articles/pfizer-and-biontech-to-test-universal-covid-19-vaccine-candidate#Universal-vaccines">noted</a> in a report on Thursday.
But now, two pharmaceutical giants, Pfizer and BioNTech, are working together to create a new super &#8220;universal&#8221; vaccine that will target multiple variants of the virus.
“A universal coronavirus vaccine has the potential to better protect against future variants of SARS-CoV-2 as well as other coronaviruses that have the potential to spill over into the human population,” Dr. Jarrod Mousa, assistant professor at the Center for Vaccines and Immunology at the University of Georgia, told MNT.
Researchers say boosters and new vaccines might not be needed with a universal vaccine.
But the scientists warn creating such a super vaccine will not be easy.
“Things we can look for in deciding the success of new or newer generation vaccines will be things like lasting — or durable — protection from infection, reductions in hospitalization and severe disease many months after vaccination, and inducement of immune response to new or unknown variants in the future,”  Dr. Dana Hawkinson, infectious diseases and medical director of the Infection Control and Prevention (IPAC) program at The University of Kansas Health System, told MNT.
“In addition, as it would be a universal coronavirus vaccine, it should help protect us from further spillover events of animal coronaviruses as we have seen with SARS, MERS, and SARS-CoV-2,” he noted.
The new effort comes as scientists are increasingly worried about a couple of new strains of SARS-CoV-2, noting that the variants appear to be able to slip past some antibodies against the virus and attack the lungs, according to a new report.
The subvariants of the now-dominant Omicron variant &#8212; dubbed BA.4 and BA.5 — appear to evade antibodies from prior infection or vaccination, making them more easily spread than other forms of the COVID-causing virus, The Daily Beast <a href="https://www.thedailybeast.com/this-may-be-the-covid-variant-scientists-are-dreading?source=articles&amp;via=rss">reported</a>. It is possible the new subvariants have evolved to target the lungs, going deeper into the respiratory tract than the less-dangerous Omicron, the outlet reported.
The Omicron variant has proven more contagious than earlier strains of the virus, but symptoms are most often far less severe. Scientists are hopeful the same holds true for the new subvariants, and so far, in the United Kingdom, where the variants have been found, hospitalizations and deaths have not increased dramatically.
“This could mean higher transmissible variants, BA.4 or 5, are in play, [and] these variants are much less severe,” Edwin Michael, an epidemiologist at the Center for Global Health Infectious Disease Research at the University of South Florida, told the Beast.
Joseph Curl has covered politics for 35 years, including 12 years as White House correspondent for a national newspaper. He was also the a.m. editor of the Drudge Report for four years. Send tips to josephcurl@dailywire.com and follow him on Twitter @josephcurl.

Covid-19 Omicron sign

Two Big Pharma Firms To Test ‘Universal’ COVID Vaccines To Protect Against Multiple Variants

Pfizer and BioNTech To Test 'Universal' COVID Vaccines To Protect Against Multiple Variants

Text messages exchanged between the <a href="https://www.dailywire.com/topic/european-union">European Union</a>&#8216;s boss and <a href="https://www.dailywire.com/topic/pfizer">Pfizer</a>’s CEO just before they sealed a lucrative COVID vaccine deal have vanished, a letter released Wednesday revealed, in the latest chapter of what Europeans are calling &#8220;delegate.&#8221;
European Commission President Ursula von der Leyen acknowledged over a year ago that she had been in regular contact with Pfizer boss <a href="https://www.dailywire.com/news/pfizer-ceo-covid-19-could-be-controlled-by-annual-vaccines-pills-to-treat">Albert Bourla</a> while they worked out a deal for 1.8 billion doses of Pfizer’s mRNA vaccine. But after a reporter sought the text messages, the commission, which is the EU&#8217;s executive body, said they are gone, according to a letter published by the EU watchdog.
&#8220;The Commission can confirm that the search undertaken by the President&#8217;s cabinet for relevant text messages corresponding to the request for access to documents has not yielded any results,&#8221; European Union Justice Commissioner Vera Jourova <a href="https://www.reuters.com/article/eu-pfizer-vaccines-von-der-leyen/eus-von-der-leyen-cant-find-texts-with-pfizer-chief-on-vaccine-deal-letter-idUKL1N2YG0ID">said</a> in a letter to the agency’s ombudsman, according to Reuters.
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The elite demand that YOU have no privacy while themselves refusing all transparency:
“Ursula von der Leyen exchanged TEXTS with PFIZER CHIEF Albert Bourla for a month when they were negotiating a massive vaccine contract”
She can ‘no longer find them’<a href="https://t.co/uR21K9gkqR">https://t.co/uR21K9gkqR</a>
&mdash; Maajid أبو عمّار (@MaajidNawaz) <a href="https://twitter.com/MaajidNawaz/status/1542092173138710531?ref_src=twsrc%5Etfw">June 29, 2022</a></blockquote>
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The deal was <a href="https://www.bloomberg.com/news/articles/2021-05-07/eu-set-to-sign-off-new-pfizer-vaccine-contract-as-soon-as-friday">announced with fanfare</a> in May of 2021, but the commission did not reveal the price of the contract. It covered 1.8 billion doses for the 450 million European Union residents from 2021-2023 as well as booster shots. Pfizer made an estimated <a href="https://www.dailywire.com/news/pfizer-set-to-rake-in-15-billion-from-covid-19-vaccine-sales">$15 billion</a> last year off of its vaccine.
Von der Leyen revealed last year that <a href="https://www.jpost.com/breaking-news/article-694877">she had exchanged texts</a> with Bourla for a month when they negotiated the deal, believed to be worth billions of dollars. When a journalist sought the texts and was denied, EU ombudsman Emily O’Reilly accused the governing body of “maladministration” and asked the commission to look again for the texts, Reuters reported.
The letter released on Wednesday said the messages are no longer in Von der Leyen’s possession, and argued that text messages are not subject to public scrutiny anyway.
“Due to their short-lived and ephemeral nature, text and instant messages in general do not contain important information relating to policies, activities and decisions of the commission,” the letter <a href="https://www.theguardian.com/world/2022/jun/29/european-commission-defiant-over-von-der-leyens-pfizer-texts">stated</a>, per The Guardian.
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O&#8217;Reilly&#8217;s office called the commission’s response “problematic on several points” and said it intends to publish a detailed report on the matter sometime in July.
European Parliament Member Kathleen Van Brempt, a Belgian Social Democrat and chair of the special committee on Covid-19, told the <a href="https://www.theguardian.com/world/2022/jun/29/european-commission-defiant-over-von-der-leyens-pfizer-texts">Guardian</a> the European Commission&#8217;s response was unacceptable.
“The complete lack of transparency benefits the industry, not European citizens,” she said.
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In addition to concerns about the secrecy of negotiations, some European leaders have sought to renegotiate the deal because many of the doses are going to waste as more residents refuse to get vaccinated, according to Reuters.

BELGIUM-EU-HEALTH-VIRUS-VACCINE

Texts Between EU, Pfizer Bosses Vanish Amid Questions About Billion-Dollar Vaccine Deal

European Union

Pfizer, the pharmaceutical giant behind one of the three main COVID-19 vaccines in the U.S. in partnership with BioNtech, <a href="https://www.axios.com/pfizer-fda-request-children-vaccine-withdraw-89125dda-a5c2-453a-9292-0606330b4182.html?utm_source=twitter&amp;utm_medium=social&amp;utm_campaign=editorial&amp;utm_content=health-pfizer">announced</a> Friday that they will be postponing their official request of the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the COVID-19 vaccine for children ages six months through 4 years of age. It had previously been reported Pfizer would be making their request by the end of February.
According to Axios, &#8220;The companies said they &#8216;will wait for the three-dose data&#8217; because they &#8216;believe it may provide a higher level of protection in this age group.'&#8221;
CNN also reported that the companies said in a press release that since &#8220;the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group.&#8221;
&#8220;This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen,&#8221; the release added.
As <a href="https://www.nytimes.com/2022/01/31/us/politics/children-covid-vaccine.html">noted</a> by The New York Times, the head of Pfizer&#8217;s vaccine research has publicly stated in the past that the company’s goal was to have vaccine and boosters ready for children under five:
<blockquote>Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek F.D.A. clearance for three doses for young children, a strategy that she said would allow for “a consistent three-dose vaccine approach for all ages.” The company switched its plan because the F.D.A. was pressing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months after that.</blockquote>
The potential EUA-approval from the FDA comes as European nations like Sweden are forgoing recommending the COVID-19 vaccine for young children, saying the risks of COVID-19 do not outweigh the benefits of the vaccine.
In January, The Daily Wire <a href="https://www.dailywire.com/news/sweden-decides-not-to-recommend-covid-19-vax-for-kids-ages-5-11">reported</a> that the Swedish government said in a press release that “children are at a significantly lower risk of developing severe COVID-19 disease compared with adults. In general, the younger the child, the lower the risk.”
“With the knowledge we have today, with a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them,” Health Agency official Britta Bjorkholm <a href="https://www.reuters.com/world/europe/sweden-decides-against-recommending-covid-vaccines-kids-aged-5-12-2022-01-27/">said</a> at a news conference in late January.
“As before during the pandemic, children are at a significantly lower risk of developing severe COVID-19 disease compared with adults,” the Swedish government <a href="https://www.folkhalsomyndigheten.se/nyheter-och-press/nyhetsarkiv/2022/januari/ingen-allman-vaccination-mot-covid-19-bland-barn-5-11-ar/">added</a> in a press release at the time. “In general, the younger the child, the lower the risk. Since the end of October 2021, the Swedish Public Health Agency has been recommending general vaccination against covid-19 from the age of 12 in Sweden. This is based on the benefit to the individual child.”
“Discussions about the decision have been held with the Pediatricians’ Association, the School Medical Association, the National Association of School Nurses, the Child Psychiatric Association, the Swedish Society for Infectious Diseases, vaccine coordinators within the regions, Swedish Municipalities and Regions (SKR), the Medical Products Agency and the Swedish Medical Council (Smer),” the Swedish government noted.
As for America, the data to determine the efficacy and necessity of vaccines for children under 5 is expected to be available in April, according to Pfizer and BioNTech.
This is a developing story; Additional information has been added after publication.
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Baby shot

Pfizer To Postpone Seeking Emergency Use COVID-19 Vaccine Approval For Children Younger Than 5

Pfizer, the pharmaceutical giant behind one of the three main COVID-19 vaccines in the U.S., is reportedly set to officially ask the Food and Drug Administration for Emergency Use Authorization of the COVID-19 vaccine for children ages six months to five years old. If the FDA were to grant Pfizer the request, shots could reportedly be available by the end of February. The possible move comes as several European nations have recommended against COVID-19 vaccines for children under 12 years old.
According to NBC News, a source <a href="https://www.nbcnews.com/health/health-news/covid-vaccine-pfizer-shot-kids-5-available-end-february-rcna14347">close to the potential development</a> said that &#8220;Federal regulators want to begin reviewing the data on two doses of the vaccine for this age group while the companies continue to gather data on a potential three-dose regimen.&#8221;
That source added that &#8220;The FDA is expected to eventually sign off on three doses for kids under 5, but regulators believe two doses in the meantime should provide enough — though less than ideal — protection against the omicron variant.&#8221;
As <a href="https://www.nytimes.com/2022/01/31/us/politics/children-covid-vaccine.html">noted</a> by The New York Times, the head of Pfizer has publicly stated in the past that the company&#8217;s goal was to have vaccine and boosters ready for children under five:
<blockquote>Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek F.D.A. clearance for three doses for young children, a strategy that she said would allow for “a consistent three-dose vaccine approach for all ages.” The company switched its plan because the F.D.A. was pressing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months after that.</blockquote>
On Tuesday, NPR reported that a Pfizer representative did not confirm or deny that the company would be submitting the approval this week, but rather that, at this time, &#8220;we have not filed a submission, and we&#8217;re continuing to collect and analyze data from both two and three doses in our younger age cohort.&#8221;
While COVID-19 cases have increased amongst children, recent data indicates that the overwhelming number of hospitalizations with COVID-19 are adults. One New York epidemiologist <a href="https://www.healthline.com/health-news/how-omicron-is-affecting-child-safety-at-school">recently told</a> HealthLine.com that children under age the of one are more likely to be admitted to the hospital simply because of a &#8220;lower threshold&#8221; for admittance:
<blockquote>According to <a class="content-link css-5r4717" href="https://nyulangone.org/doctors/1326209909/jennifer-l-lighter" target="_blank" rel="noopener noreferrer">Dr. Jennifer Lighter</a>, hospital epidemiologist at NYU Langone Health and pediatric epidemiologist and pediatric stewardship director, children still represent only <a class="content-link css-5r4717" href="https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%2012.23%20FINAL.pdf" target="_blank" rel="noopener noreferrer">2 percent</a> of COVID hospitalizations.
That said, there are a variety of reasons why hospitalizations for children are rising amid the surge of Omicron.
“Our hospitalization rate is higher for children less than 1 years of age than it is for children between 5 and 11, and that is because there is a lower threshold to admit babies with COVID. Also, if a baby under 2 months of age has a fever, they are automatically admitted,” said Lighter, as one of the reasons for a higher hospitalization rate. </blockquote>
The potential EUA-approval from the FDA comes as European nations like Sweden are forgoing recommending the COVID-19 vaccine for young children, saying the risks of COVID-19 do not outweigh the benefits of the vaccine.
On Friday, The Daily Wire <a href="https://www.dailywire.com/news/sweden-decides-not-to-recommend-covid-19-vax-for-kids-ages-5-11">reported</a> that the Swedish government said in a press release that &#8220;children are at a significantly lower risk of developing severe COVID-19 disease compared with adults. In general, the younger the child, the lower the risk.&#8221;

Vaccine

Report: Pfizer Asking FDA For Emergency Use Of COVID-19 Vaccines For Children Six Months To Five Years Old

Children

A new report states that the Biden administration’s Food and Drug Administration is pushing Pfizer and its partner, BioNTech to request emergency-use authorization for a vaccine for children as young as six months.
“Pfizer and its partner, BioNTech, the manufacturers of the vaccine, are expected to submit to the Food and Drug Administration as early as Tuesday a request for emergency-use authorization for the vaccine for children 6 months to 5 years old, which would make it the first vaccine available for that age group. Older children already can receive the shot,” <a href="https://www.washingtonpost.com/health/2022/01/31/coronavirus-vaccine-children-under-5/">The Washington Post</a> reported, adding, “The FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data, according to the knowledgeable individuals, who spoke on the condition of anonymity because they were not authorized to speak publicly.”
Pfizer spokeswoman Jerica Pitts stated, “At this time, we have not filed a submission and we’re continuing to collect and analyze data from both two and three doses in our younger age cohort.&#8221;
&#8220;As part of our ongoing commitment, we will share new updates as they become available,” she added.
Testing for a two-shot regiment yielded results that were found unsatisfactory in stimulating a strong immune response. The Post quoted a person “familiar with the situation” insisting, “We know that two doses isn’t enough, and we get that&#8230;.The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”
“Pfizer and BioNTech in mid-December <a href="https://www.nytimes.com/live/2021/12/17/world/covid-omicron-vaccines#in-a-trial-pfizer-biontechs-low-dose-shot-did-not-provoke-an-adequate-immune-response-in-2-to-5-year-olds">announced</a> that children 6 months to two years old who were given two doses of the vaccine at a tenth of the strength of adult doses produced an immune response comparable to that of young people ages 16 to 25. But among children ages 2 to 4, the response was less robust,” <a href="https://www.nytimes.com/2022/01/31/us/politics/children-covid-vaccine.html">The New York Times</a> noted.
Last Friday, Pfizer discussed updated trial data with Dr. Anthony Fauci, among other government officials. One administration official told the Post of a “robust conversation” that three doses were likely more effective than two shots, adding, “But to get to three, you have to get two shots first. … There’s interest in seeing this move forward.”
A trial was conducted in which children between six months and five years old received two doses of three-microgram shots. That amount represents one-tenth of the adult dose.
The American Academy of Pediatrics’ chief executive Mark Del Monte declared, “We understand the urgent need for a safe and effective vaccine for that age group.&#8221; He continued, &#8220;We are eager to see the data and will continue to follow the science.”
According to the <a href="https://www.covkidproject.org/deaths">COVKID Project</a>, the number of deaths from COVID-19 per million population among young children in the first year of life was tiny; between 1/1/2020 and 12/11/2021 it was 43.1, it was 8.9 between the ages of one and two, 3.1 between two and three years of age, 3.3 between three and four years of age, and 3.5 between the ages of four and five.

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