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Archive from February 26th – November 17th, 2020

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February 26

‘Mission Possible’: Pfizer and BioNtech Star in Their Own Vaccine Discovery Movie

FiercePharma reported:

It’s lights, camera, action for Pfizer and BioNTech vaccine scientists and executives. They’re starring in “Mission Possible,” a branded content film from Pfizer and National Geographic that tracks the COVID-19 vaccine’s journey to market.

The movie-length product placement is a behind-the-scenes look at Comirnaty, the now-authorized coronavirus shot Pfizer developed and produced in concert with its partner BioNTech. Pfizer provided National Geographic’s scientific storytellers “unprecedented access” to the vaccine’s development, said Sally Susman, Pfizer executive vice president and chief of corporate affairs, said.

COVID-19 Vaccine Testing on Children: What Scientists Want You To Know

ABC News reported:

Though Dr. Anthony Fauci, the White House chief medical adviser, predicted a COVID-19 vaccine may not be available for high schoolers until the fall and for younger kids until early next year, scientists and vaccine makers say studies are moving as quickly as possible to ensure the vaccines are safe and effective for the nation’s children.

Pfizer and Moderna are in the midst of testing their vaccines in children and teen ages 12 to 15 and 12 to 17, respectively, and both companies expect to have data by June. Next, the companies will start testing their vaccines in progressively younger ages groups. Currently, the Pfizer-BioNTech vaccine is authorized for persons 16 and older, and Moderna’s vaccine is authorized for those 18 and older.

Pfizer CEO: ‘Every Year You Will Have to Get Your Annual Shot for COVID’

The Defender reported:

Despite the purported 95% effectiveness of the Pfizer-BioNTech COVID-19 vaccine, Pfizer CEO Albert Bourla announced Thursday that the vaccine maker is testing a third dose of its vaccine in anticipation of annual booster shots.

In a press release, Pfizer stated its goal was to understand the effect of a booster on immunity against COVID caused by the circulating and newly emerging SARS-CoV-2 variants and to engage in ongoing discussions with the U.S Food and Drug Administration (FDA) and European Medicines Agency regarding a clinical trial to test a modified mRNA vaccine.

Pfizer director and board member Scott Gottlieb, who also served as former FDA commissioner in charge of vaccine approval, told CNBC the vaccine maker is exploring two paths to boost effectiveness of the COVID vaccine.

The first study will give 144 participants from the phase 1 clinical trial conducted last May a third lower-dosage of the current two-dose formulation. The second study involves testing a modified version of the existing vaccine designed to provide broad defense against a range of COVID mutations.

Johnson & Johnson COVID-19 Vaccine, Which Requires Just One Shot, Is Back on Track To Become Third Allowed for Use in U.S.

USA Today reported:

A government advisory committee is likely to give a thumbs up Friday to a third COVID-19 vaccine, paving the way to increased supply of the much-in-demand vaccines.

The new vaccine, from drugmaker Johnson & Johnson, offers a few advantages over the two that have been administered to 45 million Americans since mid-December, although it may be somewhat less effective.

The J&J vaccine requires only one shot; the others, from Pfizer-BioNTech and Moderna, need two. It can be kept refrigerated rather than frozen for longer, making it easier to distribute through doctors’ offices and rural outposts. And it may cause fewer side effects.

The advisory panel, called the Vaccines and Related Biological Products Advisory Committee, is likely at the end of an all-day meeting to recommend the shot for use in adults. An emergency use authorization from the acting commissioner of the Food and Drug Administration is anticipated to follow within days.

Three-shot Combo? Pfizer, Biontech Roll COVID-19 Booster Trial as Real World Data Back First Vaccine

FiercePharma reported:

The third-dose study now underway will gauge the effects of that follow-up dose on circulating and new COVID-19 virus variants.

At the same time, the companies are in talks with the FDA and EMA about studying a new booster specifically designed to tackle new variants. They’re hoping to validate “future modified mRNA vaccines with a regulatory pathway similar to what is currently in place for flu vaccines,” according to a press release.

BioNTech CEO Ugur Sahin said the partners are “evaluating a second booster in the current regimen as well as preparing for a potential rapid adaption of the vaccine to address new variants which might escape the current version of our mRNA-based vaccine.”

The Pfizer announcement follows news that mRNA vaccine rival Moderna has sent a newly designed booster shot for NIH testing. The booster targets the South African variant of the virus. Moderna is also looking at potential multivariant boosters and at its original shot as a half-dose booster.

Still, Pfizer thinks a third dose of its current shot will amp protection against variants. CEO Albert Bourla told NBC News the company believes the third dose “will raise the antibody response 10- to 20- fold.”

Germans Clamor for COVID Vaccines, but Shun AstraZeneca’s Offering

The New York Times reports:

At the start of the year, many Germans were complaining about a shortage of coronavirus vaccines that could free them from onerous lockdowns and limited social lives. Just weeks later, many are now upset that they’re not getting the vaccine they want.

As people around the world clamor for inoculations, and many countries have seen severe shortages, a preference for a vaccine developed by the German company BioNTech with Pfizer, is causing a pileup in Germany of the shot developed by AstraZeneca, a British-Swedish company, according to state health officials.

Many people — including health workers — are skipping appointments or refusing to sign up for the AstraZeneca shot, which they fear is less effective than the Pfizer-BioNTech vaccine, the officials say. As a result, two weeks after the first delivery of 1.45 million doses of the AstraZeneca vaccine arrived in Germany, only 270,986 have been administered, according to data collected by the public health authority, the Robert Koch Institute.

“The point is that we have a German-made product that is the market leader, but we are not able to get it,” said Michael Breiden, 53, a night nurse in a psychiatric hospital in the western state of North Rhine-Westphalia. He said he would prefer the Pfizer-BioNTech shot, but would take the AstraZeneca one if it meant getting immunized more quickly.

Pharma is Both Friend and Foe to EU Lawmakers as BLOC Fights for More Coronavirus Vaccines

Politico reported:

Parliamentarians are angry at coronavirus vaccine producers — but also need them more than ever.

Almost every company with EU vaccine contracts made their CEOs, presidents or chief scientific officers available for a public grilling in the European Parliament Thursday afternoon.

The session was the first time MEPs got a chance to take a hit at the bigwigs of Big Pharma, especially AstraZeneca CEO Pascal Soriot — the main focus of EU frustration over vaccine supply issues after massive quarter one shortfalls.

Anti-Vaccine Billboard ‘Played Upon The Fear of Parents,’ Violated Ad Accuracy Rules

CTV News reported:

An anti-vaccine billboard posted in Edmonton violated advertising rules on clarity and accuracy and “played upon the fear of parents,” according to Canada’s Ad Standards council.

The traffic billboard advertising Vaccine Choice Canada appeared near 142 Street and 167 Avenue during October 2019.

The ad depicted a young woman holding a child in her arms along with text reading “The science is NOT settled.”

An investigation began after the billboard was the subject of at least four complaints.

The council ruled the ad broke three clauses of the Canadian Code of Advertising Standards and was unanimous in finding the ad violated the code’s rules against misleading consumers through fear.

“Several members of Council felt that the ad played upon the fear of parents in making the wrong choice for their child in the context of ‘unsettled’ science,” the ruling reads.

“By not qualifying what was intended by the statement in question, and what specifically is not settled, the advertisement omitted relevant information, was misleading and was not supported by competent and reliable evidence.”

United Center To Host Mass COVID-19 Vaccination Site

Chicago Tribune reported:

The United Center will be a mass COVID-19 vaccination site capable of giving thousands of shots as the federal government ramps up its distribution capabilities, sources with knowledge of the plan said.

The vaccination site will be in the West Side stadium’s parking lot, which is unused due to restrictions on fans at basketball and hockey games, according to sources who were not authorized to speak publicly about the plan. An announcement is expected on Friday, and operations there could begin as soon as next month.

What You Should Know About the California COVID-19 Variant

Yahoo! News reported:

Researchers are sounding the alarm about a COVID-19 variant found in California, warning that emerging evidence shows it could possibly be deadlier, more transmissible and more resistant to vaccines.

The strain, known as B.1.427/B.1.429 or CAL.20C, was discovered by two separate research teams earlier this year. While the studies are still in the early stages and are yet to be published, scientists looking into the variant say it can’t be ignored.

“The devil is already here,” Dr. Charles Chiu, an infectious diseases researcher and physician at the University of California, San Francisco, who’s leading an analysis of the new variant, told the Los Angeles Times this week. “I wish it were different. But the science is the science.” His research suggests this strain of the virus has been circulating in California since May 2020.

Chiu’s research is expected to be made public later this week on MedRxiv, a website serving as a platform to share research before it’s formally published. A separate analysis of the strain by researchers at Cedars-Sinai Medical Center in Los Angeles was shared there late last month.

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February 25

Indonesian Nurse Dies After Being Given Chinese-Made COVID-19 Vaccine

The Epoch Times reported:

A nurse died 17 days after being vaccinated with the first dose of Chinese-made CoronaVac vaccine in East Java on Feb. 14, Indonesian media reported.

Erny Kusuma Sukma Dewi, 33, tested positive for the CCP (Chinese Communist Party) virus, commonly known as novel coronavirus, and was treated in a hospital, but then died. All her colleagues and friends tested negative for the virus, while her husband tested positive without symptoms, according to her employer Endah Woro Utami, president of Ngudi Waluyo Regional General Hospital in Blitar Regency.

“[Her body] temperature is normal. [She has] no history of illness. [She is] young. She is healthy [before being vaccinated],” Utami told Indonesian Kompas on Feb. 21.

The nurse cared for COVID-19 patients inside the hospital before becoming sick herself.

Facebook Posts Back Up VAERS Reports Linking COVID Vaccines to Injuries, Including Death

The Defender reported:

Facebook users have identified people who posted having a COVID-19 vaccination and then dying within hours.

The most recent Facebook post of 39-year-old Brittany Hall Perez of Atlanta on Jan. 12, for example, shows her wearing a mask while holding up a vaccination card with the slogan, “SAVE LIVES. Say Yes to COVID-19 vaccine,” and framing her photo. An obituary for Brittany Hall Perez of Owens Cross Roads, Alabama on Tribute Archive announced the death of the mother of two young girls on Jan. 13, but does not say how she died.

Other Facebook users have pointed to the latest post of Julie Schlachter Splattstoesser, a 50-year-old from Grand Island, Neb., whose Facebook page features the motto “The love of a family is life’s greatest blessing” and shows her most recent post on Dec. 31, 2020 with her husband and a heart-shaped logo saying, “I GOT MY COVID-19 VACCINE!”

An obituary in The Grand Island Independent states that Splattstoesser, the mother of five sons, died “unexpectedly” on Dec. 31, 2020. She had been A Clinical Research Coordinator at CHI Health Cancer Treatment Center.

Moderna Predicts $18.4 Billion In Covid-19 Vaccine Sales in 2021

CBS News reported:

Moderna Inc., the producer of one of two coronavirus vaccines currently being distributed throughout the country, said in a release on Thursday that it has already signed deals for $18.4 billion in product sales scheduled for delivery in 2021.

Additional deal discussions with several governments relating to supplies of its COVID-19 vaccine for 2021 and 2022 are ongoing.

The Cambridge, Massachusetts-based biotech company also on Thursday reported a loss of $272.5 million in its fourth quarter. On a per-share basis, the company said it had a loss of 69 cents.

Moderna Ready To Test Version of COVID-19 Vaccine Aimed at Worrisome Variant

STAT reports:

Moderna is pressing forward with a modified version of its COVID-19 vaccine meant to protect against an emerging strain of the virus, the company said Wednesday, planning to start a clinical trial as soon as regulators give the green light.

Laboratory tests have suggested that Moderna’s authorized vaccine confers less protection against the variant, known as B.1.351, than it does against other strains. Pfizer has reported similar findings with its vaccine, and human trials conducted by Johnson & Johnson and Novavax suggest vaccines designed for the original strain of SARS-CoV-2 are less effective against B.1.351 as well.

Moderna said it is seeking to test the novel vaccine on its own and as a combined shot with its current vaccine. It also plans to test whether giving a booster of the current vaccine on its own will give enhanced protection against new variants of the virus that causes COVID-19.

COVID Variants Could ‘Undermine All of Our Efforts’ if Virus Spreads Globally, CDC Director Says

CNBC reported:

New, highly transmissible COVID-19 variants “stand to reverse” the nation’s control of the pandemic and could “undermine all of our efforts” against the disease if the virus is left to proliferate in different parts of the globe, the head of the U.S. Centers for Disease Control and Prevention said Wednesday.

Top U.S. health officials have warned in recent weeks that the emergence of highly contagious variants, particularly the B.1.1.7 strain that emerged in the U.K., could reverse the current downward trajectory in infections in the U.S. and delay the nation’s recovery from the pandemic.

The problem isn’t isolated to the United States. As the coronavirus spreads, it makes huge numbers of copies of itself, and each version is a little different from the one before it, experts say. As more people become infected, the more likely it is that problematic mutations will arise.

Harris Acknowledges ‘Righteous Skepticism’ Over COVID-19 Vaccine, but Says ‘It Will Save Your Life’

Fox News reported:

Vice President Kamala Harris is urging Americans to get vaccinated for coronavirus while acknowledging the mistrust some have for medical research and development.

In an excerpt of an interview Harris did with Al Sharpton for MSNBC, Harris said that the Biden administration is distributing 2 million vaccines to local pharmacies, and that people should go out and get them.

“I got vaccinated. I can tell you, first of all, that these vaccines are safe, it will save your life,” Harris said.Harris appeared to be addressing concerns among Black Americans, which Sharpton has addressed in the past. She noted that it was a Black doctor who was instrumental in the development of one of the vaccines.

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February 24

54-year-old Man Dies After Taking COVID-19 Vaccine Covishield in Delhi

The HealthSite reported:

In yet another shocking incident, a 54-year-old sanitation worker from Delhi, died a day after receiving the COVID-19 vaccine – Covishield [the vaccine developed by AstraZeneca].

According to the reports, the deceased sanitation worker Ramesh Kumar was administered the coronavirus vaccine – Covishield on Feb. 17, and soon a day after that he started developing uneasiness.

“My father received his first shot of Covishield vaccine on Feb. 17. That day, when he returned home, he started feeling uneasy and the very next day was running temperature, which lasted for 2-3 days,” Kumar’s son Dheeraj was quoted as saying.

He further added that Ramesh Kumar was rushed to Deep Chand Bandhu Hospital following the negative symptoms post-vaccination and died there in the afternoon.

150,000 With Learning Disabilities To Be Prioritized For Vaccine

BBC reported:

People with a “severe or profound” learning disability in England and Wales were already in priority group six for the coronavirus vaccine, along with unpaid carers for those with disabilities and the elderly.

And adults with Down’s Syndrome have already been offered a jab, in priority group 4, as part of the UK’s target to vaccinate 15 million people by mid-February.

Now everyone on their GP’s learning disability register will be invited for vaccination as part of priority group six, Public Health England has confirmed, regardless of how severe their disability is.

And the NHS is being asked to work with local authorities to identify other adults, in residential care or receiving support to live in the community, who are severely affected by a learning disability and may not be registered, but who should be offered a vaccine.

FDA Says J&J COVID Vaccine ‘Safe,’ Emergency Approval Expected Within Days

The Defender reported:

The U.S. Food and Drug Administration (FDA) said today that the single-dose Johnson & Johnson (J&J) COVID vaccine is safe and effective.

The FDA’s report paves the way for the agency to grant Emergency Use Authorization (EAU) for the vaccine’s use in the U.S., according to USA TODAY.

An FDA advisory committee will meet Friday to review the data and is expected to authorize the vaccine for emergency use in individuals 18 and older within days

The vaccine maker has 4 million doses of its COVID vaccine ready to ship if the FDA grants EAU.

J&J submitted its COVID vaccine data to the FDA earlier this month. Only two months of phase 3 safety data is needed for emergency approval compared to six months of data needed for a vaccine to be fully licensed, according to CNBC.

According to the FDA’s report, J&J’s vaccine has an overall efficacy rating of 66% for preventing “moderate to severe COVID-19,” but was even less effective against the new South Africa variant. The vaccine was only 42.3% effective about a month after getting the shot in people 60 or older who had comorbidities, reported CNBC.

The Pfizer and Moderna vaccines currently require two doses and are 94% and 95% effective, though some scientists have questioned the methodology used to arrive at those numbers.

Cameroon Parents Pull Children From Schools on Rumors of Vaccine Plan

VOA News reported:

Cameroon’s education authorities are pleading with parents to return their children to schools after thousands stayed home on rumors that the youngsters would be vaccinated against COVID-19. The exodus shows the challenge Cameroonian authorities are facing to educate the public on the infection and fears of vaccines.

Cameroonian authorities said several thousand children from at least 15 schools had not shown up to class Monday morning after social media posts that the schools would vaccinate students against COVID-19, the disease caused by the coronavirus.

Police officer Willibroad Tabot, 25, says his neighbor told him about a COVID vaccination plan at school, so he kept his children at home.

“Right now, the scientific world is not yet certain on the vaccine,” he said, speaking via a messaging application from the western town of Kumba. “As of now there are different versions; we hear China has its own version, the United States has their own version, maybe Russia has their own version of the vaccine, so I do not trust it. My children cannot take it now. There are also rumors on social media saying that this vaccine is trying to cut down the population of blacks in Africa, so I am scared of it.”

Federal Law Prohibits Employers and Others From Requiring Vaccination With a COVID-19 Vaccine Distributed Under an EUA

STAT News reported:

Ever since the Food and Drug Administration granted emergency use authorization for two new vaccines, employers, schools, and other organizations are grappling with whether to require COVID-19 vaccination.

While organizations are certainly free to encourage their employees, students, and other members to be vaccinated, federal law provides that, at least until the vaccine is licensed, individuals must have the option to accept or decline to be vaccinated.

Knowing what an organization can or cannot do with respect to COVID-19 vaccines can help them keep their employees, students, and members safe and also save the them from costly and time-consuming litigation.

Even though the FDA granted emergency use authorizations for the Pfizer/BioNTech and Moderna vaccines in December 2020, the clinical trials the FDA will rely upon to ultimately decide whether to license these vaccines are still underway and are designed to last for approximately two years to collect adequate data to establish if these vaccines are safe and effective enough for the FDA to license.

The abbreviated timelines for the emergency use applications and authorizations means there is much the FDA does not know about these products even as it authorizes them for emergency use, including their effectiveness against asymptomatic infection, death, and transmission of SARS-CoV-2, the virus that causes the disease.

Vaccinating Children Could Be Key to Stifling COVID, Say Experts

The Guardian reported:

Vaccinating children and teens could be key to stifling the pandemic, experts have said, as clinical trials begin to test COVID-19 vaccines in young people.

While COVID-19 is associated with a considerably lower burden of morbidity and mortality in young people, and there is evidence that children may be less likely to acquire the infection, the role of children in transmission is unclear, according to the Royal College of Paediatrics and Child Health.

Until everybody – including children – is vaccinated, said John Edmunds, a member of the UK government’s Scientific Advisory Group for Emergencies (Sage) on Sunday, there remained a “significant risk of a resurgence” of the virus.

‘Held to Ransom’: Pfizer Demands Governments Gamble With State Assets to Secure Vaccine Deal

The Bureau of Investigative Journalism reported:

Pfizer has been accused of “bullying” Latin American governments in COVID vaccine negotiations and has asked some countries to put up sovereign assets, such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases, the Bureau of Investigative Journalism can reveal.

In the case of one country, demands made by the pharmaceutical giant led to a three-month delay in a vaccine deal being agreed. For Argentina and Brazil, no national deals were agreed at all. Any hold-up in countries receiving vaccines means more people contracting COVID-19 and potentially dying.

Officials from Argentina and the other Latin American country, which cannot be named as it has signed a confidentiality agreement with Pfizer, said the company’s negotiators demanded additional indemnity against any civil claims citizens might file if they experienced adverse effects after being inoculated. In Argentina and Brazil, Pfizer asked for sovereign assets to be put up as collateral for any future legal costs.

One official who was present in the unnamed country’s negotiations described Pfizer’s demands as “high-level bullying” and said the government felt like it was being “held to ransom” in order to access life-saving vaccines.

Pharmacists Say ‘Pooling’ COVID Vaccines Could Save Thousands of Doses

NBC News reported:

Some pharmacists say a simple solution could get thousands more people vaccinated each week, but the Food and Drug Administration is standing in the way.

It’s called “pooling” — and it’s not a new concept. Pharmacists have been doing it for years with everything from flu vaccines to some chemotherapy medications to antibiotics. It involves taking what’s left over in a drug vial and combining it with what’s left in another vial to create a full dose.

“It doesn’t look like a lot at the bottom of the bottle,” said Dr. Stephen Jones, CEO of Inova Health System, based in Falls Church, Virginia. “But ultimately, in aggregate, that adds up to a lot of doses that end up being wasted, and we’re not allowed to use that additional vaccine. But there are times where there’s almost a full dose at the end of the vial, which is heartbreaking to let that go to waste.”

Ghana Becomes First Country to Receive Covid Vaccine Through COVAX Program

CNN reported:

Ghana has become the first country to receive COVID-19 vaccines through the World Health Organization’s COVAX program on Wednesday, a joint statement issued by UNICEF Ghana and WHO Ghana said.

The shipment, consisting of 600,000 doses of the AstraZeneca vaccines, arrived at 7 am GMT Wednesday on an Emirates flight at Kotoka International Airport, in Ghana’s capital Accra.

The minister for health-designate, Kwaku Agyeman-Manu, led a government delegation to receive the consignment.

As the plane carrying the vaccines landed, state-run Ghana Broadcasting Corporation journalist Abdul Hayi-Moomen declared: “The flight carrying the vaccines that we so much look forward to receiving, I believe hope has arrived.”

The vaccines were produced by the Serum Institute of India, in the Indian city of Pune, and are part of the first wave of COVID-19 vaccines headed to low and middle-income countries, the joint statement added.