Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

Monday, November 22, 2021

The Veterinary Doctor Who Saved American Lives

A medical pioneer, whose career began in animal health, is the mystery man behind the accelerated development of the first life-saving Covid vaccine approved last November. His company, the pharmaceutical giant Pfizer, has churned out 2.5 billion dosages for distribution to 116 nations. 

Dr. Albert Bourla, the drug firm's chairman and chief executive officer, steered the company in the development of a ground-breaking vaccine using mRNA technology. He green-lighted $2 billion in research and development for the technology.  His decision was a gigantic risk for his company. 

Although mRNA technology had been studied for decades, many in the scientific community considered it a tricky challenge to use it for a COVID vaccine. Scientists hoped an mRNA vaccine could be engineered to teach our cells to make a protein that triggers an immune response to COVID.  

Dr. Bourla made the decision to collaborate with BioNTech, a German firm with experience in the field of immunology and a leader in the development of therapeutics for the treatment of cancer.  The partnership marshaled the resources and scientists of two firms to tackle the vaccine conundrum.  

Development of the vaccine turned out to be a supply chain nightmare.  The 280 different materials or components in the vaccine were sourced by suppliers in 19 countries.  Adding to the challenge, many of the countries were locked down, including the U.S. It was a daunting obstacle to overcome. 

Additionally, Pfizer had to create a manufacturing process from scratch.  An army of scientists, engineers and manufacturing workers developed an efficient manufacturing machine for the vaccine. The first dosages were shipped on December 15, less than nine months after the project was launched.

The vaccine development was hailed as a stunning scientific achievement, reducing the timeframe from years to months.  For Dr. Bourla, it was the capstone of a more than 25-year career at Pfizer that began in 1993 when he was hired as the firm's technical director in the Animal Health Division in Greece.

Dr. Bourla holds a Doctor of Veterinary Medicine degree and a PHD in the Biotechnology Reproduction from the Veterinary School of Aristotle University in Thessaloniki, Greece.  An unlikely degree path for someone who would occupy the CEO office at the one of the world largest pharmaceutical companies.

What makes his life story fascinating is that he was born in the Ancient Greek city of Salonica, where his mother and father were among the few Jews to survive Nazi Germany's brutal occupation. Of the more than 50,000 Jews living in Salonica before World War II, about 2,000 survived the death camps.

Bourla's father, uncle and two brothers eluded the initial Nazi roundup for Jews in the Greek city, escaping to Athens on fake ID's supplied by leaders in the Greek Orthodox Church. His mother dodged death under miraculous circumstances.  

She was facing execution by Nazi soldiers in Salonica. She was lined up against a brick wall facing a machine gun just feet away.  Seconds before the firing began, two Nazi soldiers arrived in the nick of time with an order for her release. They whisked her away to safety.

According to Dr. Bourla, his mother's freedom was purchased by a bribe paid by her wealthy Christian brother-in-law to Salonica's top Nazi SS officer. Her father and three of his brothers found each other after the war had ended in the old city.  

Dr. Bourla's says his parents' account of their gruesome memories of Nazi occupation motivated him to lead a positive life, despite his family's past, cocooned in the darkness of Germany's horrific occupation of his homeland.

The irony of Pfizer's decision to ally with a Germany company to create a vaccine that saved countless lives is not lost on Dr. Bourla. He credits his parents with engraining a spirit of forgiveness and thankfulness in their children. 

"They never spoke to me about revenge," Dr. Bourla recalls. "They never told us that you should hate those that did that to us.  The way their stories always ended was a celebration of life. 'We were almost dead and now we are alive.  Life is wonderful.'"

These lessons are worth celebrating on this Thanksgiving and throughout our lives. 

Sunday, February 7, 2021

News and Social Media Sabotaging Vaccinations

Even as more Americans roll up their sleeves for life-saving COVID-19 vaccinations, suspicions fueled by the news media and misleading information on social media sites are causing many to skip the shot. Public skepticism is endangering America's effort to beat a menacing, year-long pandemic.

Worries over the safety, the "rushed" nature of the pharmaceutical development and politicization of the vaccines are behind the public reluctance to be vaccinated.  Online conspiracies are spiraling out of control even as millions of vials of the vaccines are dispatched to every state.  

In little more than a month, 59.3 million dosages of the Moderna and Pfizer-BioNTech vaccines have been dispatched. States have struggled to administer 42.1 million shots, despite months of lead time to develop public health plans.  A total of 9.1 million Americans have received the required two dosages.

While the snail's pace is unsettling, the more vexing issue is the public mistrust, apathy and even hostility toward promising vaccines that will end America's lockdown nightmare.  This anti-vaccine drumbeat is at odds with fatality statistics: More than 2 million worldwide and 460,000 in the U.S.

Pew Researchers tracked mushrooming apprehension among Americans.  In May, a Pew survey showed 27% of Americans would decline a COVID vaccination.  By November, that number had surged to 39%.  Polls indicate many are adopting a wait-and-see attitude to judge the vaccine's safety.

Speeding up the distribution and inoculation process will not halt the pandemic if four-in-10 adults are unwilling to be vaccinated.  Health experts believe that a vaccination rate of 75%-to-80% of Americans could potentially allow the country to achieve herd immunity later this year.

"By the time we get into fall, we can start approaching some degree of relief where the level of infection will be so low in society we can start essentially approaching some form of normality," says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

His encouraging assessment has failed to motivate many Americans to bare their arms for a vaccination.  Here are just a few examples of what is happening across the country:

  • Center for Disease Control (CDC) statistics document that only 37.5% of skilled staff at nursing homes are agreeing to be vaccinated.  The CDC reviewed data from 11,000 nursing facilities.
  • Public records in Los Angeles show that between 20% to 40% of all frontline health workers refused to be vaccinated.
  • In December about 60% of nursing home staff in Ohio declined to take the vaccines.  The state's governor expressed alarm at the statistics.
  • The director of the United Memorial Medical Center in Houston publicly complained about the resistance from staff to take the vaccine.  About 50% of nurses are choosing not to be vaccinated.
  • The New York City Firefighters are balking at being vaccinated. More than half of the 2,000 members of the Firefighters Association say they will not take a shot.
When frontline health workers and nursing home staff turn thumbs down on being vaccinated, it sends the wrong signal to average Americans.  They rightly wonder: If people in the health care profession reject the vaccines, they must know something is wrong with the safety and efficacy of the shots.

Cynicism over the vaccine unfolded even before the first vaccines were approved.  Democrats complained former President Trump was "rushing" the scientific development of a vaccine for political reasons. There are many examples that could be cited, but here's just one:

"We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic," Speaker Nancy Pelosi said in a public statement issued October 6.

Throughout the presidential campaign, a Democrat theme was to raise alarm about the administration's handling of the pandemic and to dismiss the promise of vaccines to eradicate the virus.  The media echoed that narrative and deliberately downplayed the advance of science on the vaccine front.    

A new National Bureau of Economic Study of news coverage found a striking difference in the way the U.S. media covered the pandemic compared to journalists in other countries.  A staggering 91% of stories by major news outlets were negative versus 54% in non-U.S. media.  

The study, published by Dartmouth College and Brown University scholars, analyzed more than 20,000 news reports from 15 top U.S. media outlets and 39 international sources.  Among their discoveries was the way the media dismissed the likelihood of having a successful vaccine.

The authors noted that a vaccine was mentioned in 1,371 stories during the period while researchers found 8,756 print and broadcast reports involving Mr. Trump not wearing a mask and 1,636 mentions of the former president's endorsement of hydroxycholroquine. 

Some still want to pin the blame on President Trump.  But Mr. Trump touted the vaccines.  Vice President Mike Pence and members of both the Trump and Biden Administrations were shown receiving vaccinations to tamp down any speculation that the vaccines were unsafe.

Today every instance of someone experiencing a negative reaction to the vaccine is covered by the media in alarmist tones.  When a Democrat congressman tested positive after receiving two dosages of the vaccine, it erupted into a national news story.  Negative news about the vaccines stokes fear.     

Social media has been a sewer of conspiracy theories about the vaccine.  Some of the claims: The needle used to vaccinate people has a microchip with the mark of the Beast; vaccines alter your DNA; vaccines contain a microbe that tracks you; and the vaccines cause COVID. 

Ironically, social media platforms are removing what they consider "violent" content posted by conservatives, but allow conspiratorial scams to fester online, which sow the seeds of distrust for the vaccines and allow disinformation to spread unchecked.      

The damage already done to the public's perceptions will require a massive educational campaign by the health and medical community. It will be a long slog.  However, if it is not done quickly, there is very little light at the end of a long and deadly tunnel.   

Monday, December 14, 2020

Scurrilous Media Raises Fears About Vaccine

Coronavirus is the first disease to kindle a anti-vaccine flrestorm even before the immunization is publicly available.  Surveys show disturbing numbers of Americans will refuse to be vaccinated, despite the endorsement of public health officials.  A dishonest media is guilty of swaying public opinion. 

Ever since President Trump spearheaded Operation Warp Speed to jumpstart research into developing a vaccine, a politically motivated media has deliberately draped ominous clouds of suspicion over the effort.  The scientists are being rushed.  Protocols are being skirted to benefit the president, the media insisted.  

This insidious effort, aided by Democrats, inflamed an anti-vaccine sentiment even before the results of immunization trials were publicly disclosed. A responsible media should be educating the public about the benefits rather than twisting the vaccine into a partisan or ideological issue.  It is disgustingly perverted.

Unfortunately, the unethical media has succeeded.  The non-partisan Pew Research Center unveiled a study documenting the propaganda's impact.  In May, 72% of Americans surveyed said they would get the vaccine.  By September, the percentage plummeted to 51%.  That is a precipitous attitudinal shift.

The research discovered that three-quarters of Americans think it is likely that a COVID-19 vaccine will be approved in our country before its safety and effectiveness are fully understood.  Another 78% are concerned the approval process is moving too fast.  That tracks will the media's coverage of the vaccine.

In this climate, the Federal Food and Drug Administration on December 11 authorized the emergency use of the COVID-19 vaccine produced by Pfizer and BioNTech to turn the tide in the battle against the Coronavirus. Vaccine shipments are underway today.  It won't matter if Americans don't get the shot.  

The media and the incoming administration do not want President Trump to get one iota of credit for delivering a knockout punch to the spread of the virus.  They will do whatever is necessary, even deceive the public, to ensure Americans will be skeptical of the Trump-led campaign.

If you doubt the premise, you have not be reading the New York Times, Washington Post or watching the major network news.  No opportunity has been wasted to quote scientists, professors, immunologists and health officials, who have what the media terms "grave doubts" about the vaccine.

Here is just one sample from Alison Buttenheim, an associate professor of nursing and health policy at the University of Pennsylvania, who referred to the situation as a perfect storm of "justified distrust." "I've heard people say, 'I'll get the European one,'" she said, adding others want Anthony Fauci to get it first. 

The naysayers are the grist of the media propaganda mill.  But most experts in the field are excited about the prospect of a vaccine to help arrest the surge of Coronavirus cases.

Dr. Tom Frieden, former director of the Centers for Disease Control and Prevention (CDC) from 2009 to 2017, cites the results of the trials as good news for Americans.  "The most obvious is the striking efficacy of the vaccines being produced by Moderna, Inc. and Pfizer and its partner BioNTech. "

He points out that the vaccines are game changers with efficacy levels of 90% or higher.  "A 70% uptake (people who voluntarily take the shot) vaccination could end the explosive spread of the virus," he noted in a piece he authored for The Wall Street Journal.  Endorsements like this are rare.

The injustice of the media cries of wolf is this: it preys on the increasing public apprehension about all vaccines, including those for children.  A study in the Journal of Pediatric Pharmacology and Therapeutics  cited the "parental refusal of vaccines" for children as a reason preventable diseases are more prevalent.

The research included a study that found 77% of parents reported having concerns about one or more childhood vaccinations.  Reasons cited are religious beliefs, personal or philosophical reasons, and safety concerns.  The report mentions public education as the key factor in gaining parental acceptance and trust.

Adults are just as nervous about vaccinations for themselves. Estimates from the CDC conclude in the last 10 years less than half of American adults received a flu shot.  It reached a high of 43.6% in 2014 and a low of 37.1% in 2017.  Those are worrisome statistics with the COVID vaccine arriving soon.

As the nation's hospitals, pharmacies and doctors are poised to begin vaccinations, the bureaucrats are still playing politics with Americans' health.  New York's Governor Andrew Cuomo has already signaled that racial preferences will be considered in decisions about who gets vaccinated first.

This flies in the face of commitments by Cuomo and other health officials that those in nursing homes would be a top priority, since they have suffered disproportionately from the virus.  There are 2.1 million adults in nursing homes, less than 1% of the population, but they represent 40% of all COVID deaths. 

In San Antonio and Bexar County, health officials are lobbying to make the vaccine available to teachers in the first wave, despite earlier assurances nursing home staff and patients would get preference. This stunning reversal is nothing more than a blatant political move to placate the teachers union.  

It is unconscionable for nursing home staff and their patients not to be prioritized for the vaccine.  Shame on those who continue to politicize this virus. The attitude of politicians and cultural elites is that old people are going to die soon anyway, so why waste the vaccine on them?  It reeks of a culture of death.

Politicians are not heeding the advice of an independent advisory panel of infectious disease experts, doctors and scientists. The group, known as the Vaccines and Related Biological Products Advisory Committee, recommended parcelling out the vaccine to healthcare workers and nursing homes first.

FDA approval lagged behind the United Kingdom and Canada, which green-lighted COVID vaccines two weeks before the U.S.  The UK rolled out its vaccination program last week, giving the first injection to a 90-year old woman. However, the U.S. media focused on a single negative to hike fears.

Big media hyperventilated over two Britons who suffered significant allergic reactions to the Pfizer vaccine.  Most overlooked the fact both individuals recovered. Of course, there will be those who endure allergic reactions to the COVID vaccine, as there are with even the most common vaccines.

The World Health Organization (WHO) estimates the odds you will have a severe allergic reaction to a vaccine are about 1 in 760,000. To put that into perspective, your chances of being struck by lightening are a little higher: 1 in 700,000.  Don't expect those facts to appear in any American media.

A respectable media would be celebrating the arrival of vaccines that are 90% effective, not unnecessarily raising the specter of health-threatening outcomes.  The prediction here is that the media is setting the stage for the Biden Administration to halt vaccinations for more study to guarantee its safety.

It may sound outlandish but the media's unhinged hatred of all things Trump allows for such dire predictions.  Democrats cannot abide a Trump triumph.  Why else would the media be fostering an environment of distrust for a life-saving vaccine?

Monday, November 23, 2020

Meet America's Clinical Trial Volunteer Heroes

They are nameless, faceless and unsung.  They could be a grad student, a writer or that individual you passed in the grocery aisle. These invisible Americans are risking their personal health to volunteer for about a 1,000 COVID-related research trials in our country. They are America's newest heroes.

Upwards of 100,000 Americans have volunteered for vaccine trials in America.  Thousands are participating in drug trials in other nations. Without these volunteers, the clinical trials required to approve the vaccines would be impossible.  The research ensures the vaccine's safety and effectiveness.

Let's reveal the identities of a few of these courageous volunteers: Ian Haydon, a 29-year old from Seattle. Sophia Upshaw, a 22-year-old graduate student from Atlanta.  Jennifer Haller, a 43-year-old mother of two. And Elle Hardy, an Australian freelance writer based in the United States.

Their personal stories reflect something about the nearly undefinable American spirit.  People in our country are imbued with a desire to help others out of a sense of patriotic duty.  We don't read or hear much about this trait any more yet it is instilled in all who believe in the principles of this country.

Take Jennifer Haller for example.  She had participated in other clinical research trials before volunteering for the COVID test.  Her son had enrolled in three medical trials unrelated to the virus.  She believes in the power of clinical studies, recognizing their value to protect the lives of others.

When she volunteered for the COVID trial by Kaiser Permanente, Jennifer did not realize she would be the very first patient receiving a vaccine that had never been tested on human beings.  Was she frightened? Did she consider aborting the opportunity?  Allow Jennifer to answer in her own words.

"No.  But not because I am super strong, but because I wanted to be able to give something back and contribute in some way.  A lot of people can't do something like what I'm doing.  They couldn't potentially take off work or be healthy enough to participate..." she says in a CNN interview. 

Her unselfishness is inspiring.  So is the story of volunteer Ian Haydon, who endured a systemic adverse reaction to the vaccine being developed by Moderna Therapeutics.  He is one of three people in the research effort to experience side effects from the revolutionary vaccine.

Moderna, a Cambridge, Massachusetts, based pharmaceutical firm, is using a genetic material that triggers the body to create a protein that trains the immune system to recognize the virus as an invader. Moderna partnered with the National Institute of Allergy and Infectious Disease (NAID). 

Despite suffering a negative reaction, Haydon endorses the vaccine. "I understand that sharing the story, it's going to be frightening to some people.  I hope that it doesn't fuel any sort of general antagonism towards vaccines in general or towards even this vaccine, " he allows. 

Haydon's concern for others motivated him to sign up for the Phase I trail designed to be the first opportunity for researchers to evaluate the vaccine on humans. Although the vaccine made him sick, Haydon would do it again. "I don't regret the decision I made to enroll in this study."

Spoken like a patriot swayed by his altruism.  Haydon, a communications manager, learned about the study from a colleague who forwarded a link.  Even though he admittedly "doesn't like needles," He immediately applied and eleven days later Moderna contacted him.  Bravery in action.

Sophia Upshaw also leaped at the chance to help advance research on a vaccine.  "It's something I could do," she told Science News.  "We are all feeling helpless and trying to help in any way we can...Everyone is trying to do what they can," she explains.  

Sophia concedes her family was worried about her participation. "They are happy that people are choosing to participate in the trial. They're just not happy that it's me," she admits in an interview.  Her parents were relieved when Sophia did not develop a severe reaction to the vaccine.

Elle Hardy's original journey from journalist to clinical research volunteer was spurred by simple economics.  She was broke.  That sparked her interest in a medical trial for an anthrax vaccine several years ago.   She made a few dollars, but research volunteers certainly don't get rich.  

She was in South Korea this February doing research on a major Coronavirus outbreak and managed to escape infection.  She returned to her native Australia, but eventually flew to the U.S. to continue her freelance journalist career.  An opportunity arose when recruiting began for a Phase III clinical trial. 

"I wish I could say that I signed up for the vaccine trial out of some sense of public service.  But my first response when I was asked to take part in the trial was, 'Hell yes,' because I wanted a chance to get some protection from the Coronavirus as soon as possible," Elle confesses in a story in Business Insider.

Before she was admitted to the trial, the clinic reviewed her medial history, her medications, administered a pregnancy test, measured her blood pressure and pulse and extracted eight vials of her blood. Throughout the trial the clinicians monitored her blood samples.  

The trial was the Phase III test for Moderna's mRNA-1273 vaccine, which the pharmaceutical firm announced results show the drug is 94.5% effective.  Elle was one of 30,000 people enrolled in the study across multiple sites in the United States.  Participants were either given the vaccine or a placebo.

Elle is certain she did not receive the placebo.  She had a slight reaction to the two doses administered by the clinicians. A recent antibody test confirmed she was positive, meaning the vaccine had done its job giving her body the means to fight off Coronavirus.

"I wasn't concerned about receiving an experimental drug," Elle says. "In spite of political and market pressure, I can't see pharmaceutical companies blowing up their reputations by pushing forward with a vaccine that's dangerous to humans."

Ongoing trials for other Coronavirus drugs still need volunteers. Online screening surveys are available for those who wish to participate.  Compensation varies based on the vaccine trial you enter.  Some drug firms offer pay for travel and time involved with participating. 

However, most volunteers don't raise their hands for the money.  They view their participation as a noble calling and a selfless way to perhaps spare lives that otherwise may be taken by Coronavirus. Every American might pause this week to give thanks for these heroic volunteers.   

When the vaccine arrives soon, a grateful nation should celebrate Jen, Ian, Sophia and Elle along with the thousands of other fearless trial volunteers who made mass inoculation possible.