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COVID-19 antibody therapies available right now require infusions or subcutaneous injections. However, a more convenient type of therapy could be on the way.In this Motley Fool Live video recorded on Sept. 22, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss the leaders in the race to develop a COVID-19 pill. (Note: This recording was made prior to Merck's (NYSE:MRK) announcement on Friday of positive results from a late-stage study of its oral antiviral therapy molnupiravir.)
Keith Speights: RedHill Biopharma's (NASDAQ:RDHL) oral COVID-19 candidate recently just flopped in a phase 3 study. But there are several other oral COVID antiviral therapies that are in development. In your view, which companies appear to be the leaders in the race to develop a COVID-19 pill?
Brian Orelli: Yeah, there are really three pills. Merck and Ridgeback have molnupiravir. They're expecting data later this year in outpatients, and then for post-exposure prophylaxis in the first half of next year. Pfizer (NYSE:PFE) has another drug that goes by the code-name PF-07321332.
Speights: What was that again, Brian? [laughs]
Orelli: The data for that in outpatients is also expected later this year. Then Roche (OTC:RHHBY) and Atea (NASDAQ:AVIR) have a drug called AT527 -- a lot easier to say. That data in outpatients is also expected later this year. I think it's a three-horse race.
In theory, maybe all of them work. I think Merck's and Ridgeback's wasn't necessarily designed specifically for the coronavirus that causes COVID-19. I believe Pfizer's was, so maybe it has a slight advantage, but we have to wait and see about the actual data. I think this is a difficult space to invest in somewhat from obviously the three-way competition, but also because of the endpoints.
A lot of companies have had trouble actually proving that their drugs actually help patients. Do you do look at viral levels, or do you look at "does it keep them out of the hospital?" All those different endpoints can affect your actual outcomes of whether you can prove your drug works. Whether it actually works is completely different question. It's just whether you can prove your drug works.
I think that it's a difficult space for investors to invest in, and then of course, all three of those companies -- Merck, Pfizer, and Roche -- are obviously all really large companies. Adding one additional drug, even if it has a billion-dollars-plus in sales potential isn't going to necessarily move the needle that much on the revenue side.
Speights: Those are really good points, Brian. I did see that Pfizer is projecting that, assuming it's phrase 3 studies go well, Pfizer has projected that it could file for EUA for its COVID-19 pill, perhaps by the end of this year. So this is a story that is probably going to develop more quickly than you might even think because of the EUA path here.
I would think that if any of these pills do get authorization, and again, like you said, there's an uphill climb to prove that they actually work, but if they do win authorization or ultimately approval, they could bring in a big chunk of sales.
Orelli: I think we saw what Regeneron (NASDAQ:REGN) did maybe to $2.2 billion in sales to the US government. That's infused drug and these are oral drugs which are obviously a lot easier to take, and so you can expect that their use might go up, and then their manufacturing is probably easier. I would expect that they can probably make more of it, and that would help them with sales.
Speights: I would even see these pills being taken by people who are fully vaccinated too, because of the vaccines aren't 100% effective, and so if there's a post-exposure prophylaxis that has been proven to be effective, then you could see both unvaccinated and vaccinated people taking these pills -- again, if they make it to market.
Orelli: Yeah. Again, giving people a pill versus having them sit in an infusion center -- if they've been exposed then you're going to have to take a lot of more precautions to keep them isolated, and so that makes things difficult, where if you [can] just give them a pill, they can just go take it at their own house. I think that makes it a lot easier in the prophylaxis category as well, but we'll have to see what the data pans out there.
This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.
Jordyn Locks couldnt believe the call she got from a Rider University administrator: The sophomore won a full year of free tuition, valued at more than $46,000, just for being vaccinated against COVID-19.
I was like, What? This has to be a joke, said the exercise science major from Bear, Del. When I submitted my vaccination card, I didnt even know that was a thing.
Locks was one of three students out of a potential pool of about 2,700 to win that honor under an incentive program by the New Jersey university to encourage students to get vaccinated before the school year started.
As universities grapple with how to keep a typically invincible-feeling population safe and in-person, other area schools have dangled carrots, too albeit less exciting. Pennsylvania State University offered drawings with cash prizes, gift cards, and footballs autographed by coach James Franklin. West Chester University offered a chance at scholarships. Nationwide, motivation has included everything from laptops, photo shoots, concert tickets, and free parking to pizza parties and therapy dogs.
READ MORE: A professor got a heart transplant so he wanted to teach online. His university said no.
As the school year continues, universities also are applying the stick: Penn State recently placed more than 100 students at its University Park campus on interim suspension for failing to report for required COVID-19 testing after they had not submitted proof of vaccination.
West Chester on an interim basis suspended housing for 39 students who failed to report for testing. West Chester is one of 14 state universities not requiring the vaccine, but West Chester mandates that unvaccinated students living in residence halls submit to random testing.
They are no longer permitted to reside on campus until they test and submit their results, said Nancy Santos Gainer, a West Chester spokesperson.
Other colleges are threatening similar measures, including preventing students from registering for spring classes and having access to campus buildings. Drexel University has said students who are not exempt and fail to get the vaccine which the university has required and which Philadelphia has mandated for college students and staff by Oct. 15 could face other disciplinary action too, including dismissal, said spokesperson Niki Gianakaris.
Vaccination rates are already very high at Drexel, with about 96% of students and staff vaccinated, and others in process as the school completes its second week of classes. Less than 2% of students and 1% of employees have received exemptions, Gianakaris said.
Across the region, vaccination rates vary, with many schools that required the vaccine having more than 90% of students and staff vaccinated, and those that did not somewhat less. At West Chester, 66% of students taking classes in-person and 62% of employees have provided proof of vaccination, Gainer said. At Penn State, which does not require it, 81% of staff and 87% of students are vaccinated, but in the residence halls, it is more than 90%.
I think were getting to the same place without using the word mandate, said Damon Sims, Penn States vice president of student affairs.
So far, none of the local campuses have had to revert to remote instruction for the semester, and some campuses where there were worrisome case spurts earlier in September, including Villanova and La Salle, seem to have stabilized.
READ MORE: This time last year, Temple went virtual because of case counts. How do schools compare now?
At Villanova, where 95% of students are vaccinated, active cases had dropped to 13 by Friday after an uptick last month, which caused the university to tighten some measures. Villanova, which requires the vaccine and also mandates twice-weekly surveillance testing for unvaccinated students and employees, and random testing for the vaccinated, has not had to resort to disciplinary measures, said spokesperson Jonathan Gust. If a student or employee misses testing, they receive a reminder and then a warning email, he said.
Temple University sends noncompliant students multiple emails and then takes away their access to campus buildings, said spokesperson Steve Orbanek. If they still fail to get tested, they are referred to the student conduct office, he said.
At Temple, 96% of the 2,584 students who are required to submit to testing have complied, he said. About 86% of students and staff are fully vaccinated.
Penn State announced the interim suspensions of noncompliant students on Sept. 21. By early last week, about half the students had reported for testing or got vaccinated or had already been vaccinated and just needed to upload their information, Sims said. They were removed from suspension.
None of the students lived in the residence halls, but they were excluded from classes, university activities including football games, and campus facilities, he said.
READ MORE: Vaccinated vs. unvaccinated roommates: As college students move in, some parents and students have concerns
The suspensions occurred only after students had missed three weeks of testing and the university called, emailed, and, in residence halls, even knocked on students doors, he said. Ten staff members from student affairs ran a phone bank, Sims said. Those efforts averted suspensions for several hundred students.
We want as many people as possible to be vaccinated, he said. We hope that most are willing to do that. We also want them to upload the data proving that they are vaccinated so we know that.
About 55 students remained on interim suspension as of Wednesday, Sims said. More students, though, could be added each week if they dont comply, he said. While all the suspensions occurred at the 48,000-student University Park campus, Sims said other Penn State campuses are preparing to take similar action if necessary.
The Coalition for a Just University, a group of largely university professors who have been critical of Penn States response to COVID-19, would have rather seen the university mandate the vaccine, said Gary King, a professor of biobehavioral health at University Park and a coalition spokesperson.
Part of the measures they are taking are the result of the measures they didnt take, he said.
At Rider, administrators announced the free tuition incentive July 29. The university had previously said all students without medical or religious exemptions would need to be vaccinated by the fall semester, but only 65% had uploaded their vaccine cards.
By Aug. 5, the percentage jumped to 85, said Drew Aromando, vice president for enrollment management.
Its difficult to gauge whether [the tuition incentive] was exclusively the reason, he said. There were a number of things we were doing to try to move the needle.
But it definitely helped, he said.
All students were eligible except those already receiving full free tuition and those taking all classes online. A winner was randomly chosen from each enrollment category: traditional undergraduate, graduate, and continuing education for non-traditional-age students. Winners received the tuition, less other institutional aid or scholarships they already had, Aromando said.
Locks said for her, the win amounted to about $19,000. Between her campus job as a resident adviser and free tuition, she said college isnt costing her anything this year. Last fall, her first at Rider, vaccines were not yet available and all her classes were on Zoom.
Its so much better this year, she said. I get to finally wake up and walk to class and see other students.
Aromando said 96% of students are fully vaccinated and the remaining 4% have approved exemptions and must submit to weekly testing. Since the semester began, Rider has had 17 COVID-19 cases among students and staff as of Sept. 24, according to its dashboard.
Locks said she was vaccinated before Rider announced the incentive. Even if the vaccine wasnt required, she said she would have gotten it.
If I can do my part and slightly change the world with my little impact, she said, it will make me feel better.
After implementing first-in-the-nation school masking and staff vaccination measures, California becomes the first state to announce plans to require student vaccinations adding the COVID-19 vaccine to list of vaccinations required for school, such as the vaccines for measles, mumps, and rubella
Students will be required to be vaccinated for in person learning starting the term following FDA full approval of the vaccine for their grade span (7-12 and K-6).
SAN FRANCISCO At a school in San Francisco, Governor Newsom announced plans to add the COVID-19 vaccine to the list of vaccinations required to attend school in-person when the vaccine receives full approval from the Food and Drug Administration (FDA) for middle and high school grades, making California the first state in the nation to announce such a measure. Following the otherfirst-in-the-nation school masking and staff vaccination measures, Governor Newsom announced the COVID-19 vaccine will be required for in-person school attendancejust like vaccines for measles, mumps, rubella and more.
The state already requires that students are vaccinated against viruses that cause measles, mumps, and rubella theres no reason why we wouldnt do the same for COVID-19. Todays measure, just like our first-in-the-nation school masking and staff vaccination requirements, is about protecting our children and school staff, and keeping them in the classroom, said Governor Newsom. Vaccines work. Its why California leads the country in preventing school closures and has the lowest case rates. We encourage other states to follow our lead to keep our kids safe and prevent the spread of COVID-19.
Thanks to the states bold public health measures, California continues to maintain thelowest case rate in the entire countryand is one of only two states to haveadvanced out of the CDCs high COVID transmissioncategory.More information about the announcement can be foundhere.
The vast majority of school districts have reported that over 95% of students have returned to in-person instruction this school year, as can be seen on the statesStudent Supports & In-Person Dashboard. Thanks to unprecedented resources and public health measures (measures shown to be highly effective), California isleading national trends in preventing school closuresand keeping kids in classrooms, accounting for only 14 out of over 2,000 school closures nationwide, or roughly 0.7% despite the fact that California educates an estimated 12% of the nations public school students. If Californias rates had aligned with national trends, the state would have seen upwards of 240 school closures.
In order to further protect students and staff and continue supporting a safe return to in-person instruction for all students, the Governor directed the California Department of Public Health (CDPH) to follow the procedures established by the Legislature to add the COVID-19 vaccine to other vaccinations required for in-person school attendancesuch as measles, mumps, and rubellapursuant to the Health and Safety Code. COVID-19 vaccine requirements will be phased-in by grade span, which will also promote smoother implementation.
Upon full FDA approval of age groups within a grade span, CDPH will consider the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services, the American Academy of Pediatrics, and the American Academy of Family Physicians prior to implementing a requirement. Following existing statute, full approval of ages 12+ corresponds to grades 7-12, and full approval of ages 5-11 corresponds to grades K-6. Students who are under the age of full approval, but within the grade span, will be required to be vaccinated once they reach the age of full approval (with a reasonable period of time to receive both doses), consistent with existing procedures for other vaccines. The requirement will take effect at the start of the term following full approval of that grade span, to be defined as January 1st or July 1st, whichever comes first. Based on current information, the requirement is expected to apply to grades 7-12 starting on July 1, 2022. However, local health jurisdictions and local education agencies are encouraged to implement requirements ahead of a statewide requirement based on their local circumstances.
Governor Newsoms historic$123.9 billion Pre-K and K-12 education packageis providing an unprecedented level of school and student funding to transform the states public schools into gateways of equity and opportunity, supporting the potential of every California student by: achieving universal transitional kindergarten for four-year-olds by 2025, expanding afterschool and summer programs, providing universal free school nutrition, increasing the number of well-prepared staff per pupil, creating full-service community schools to support the mental and social-emotional well-being of students, and more.
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SPRINGFIELD To increase access and availability of COVID-19 services, five of the states ten Community Based Testing Sites (CBTS) now offer the COVID-19 vaccine to patients age 12 and older. All three vaccines are available during operating hours. No appointment or doctor referral is needed at state operated sites, and all services are offered at no cost to the individual.
With this latest wave of COVID-19 cases and hospitalizations, overwhelmingly caused by the Delta variant, we continue to work to expand access to both COVID-19 testing and vaccination, said IDPH Director Dr. Ngozi Ezike. Testing is crucial for identifying new cases to reduce the spread of the virus, and the COVID-19 vaccine is our clearest path to ending this pandemic.
Parents or guardians of children younger than 17 years of age must be present and provide written consent in order for the minor to receive the COVID-19 vaccine.
Due to the demand for these services, there could be varied wait times associated with these drive-thru community-based testing sites. Please be patient. If you are experiencing a medical emergency, you are urged to call your doctor or emergency department to seek immediate care and instructions.
A list of public and private testing sites can be found on the IDPH website at http://www.dph.illinois.gov/testing. For additional vaccine locations, please visit www.vaccines.gov.
Dr. Vanessa Kerry, cofounder and CEO of Seed Global Health, discusses the need to place equity and fairness at the heart of the global health agenda.
Access to Covid-19 vaccines remains elusive for children as well as adults in many parts of the ... [+] world.
This week parents across the United States were greeted with the news that Pfizer was submitting data to the FDA that its Covid-19 vaccine has been found to be safe and effective for children as young as five. As a parent myself, I imagine my sighs of mingled relief, exhaustion, and joy were mirrored in millions of households.
Equally, as a medical doctor and public health professional, I am pleased to see the data showing how the vaccine generates an appreciable antibody response and proving it is safe.
But that doesnt erase how exceedingly difficult the last two years have been. Parents have borne a unique burdentrying to balance the demands of work, a dramatic and difficult shift to remote school for kids, and protecting their families from Covid-19.
And the joy that parents like me felt this week has yet to extend to too much of the world, where access to Covid-19 vaccines remains elusive for children as well as adults.
In addition to being a doctor and a parent, I also head Seed Global Health, a nonprofit organization that seeks to improve health around the world by ensuring no country lacks the doctors, nurses, and midwives needed to care for individuals and communities. Yet every day in our work, we see historic inequities and injustices in health play out just like this vaccine rollout.
Countries like Malawi have fewer than one doctor for every 25,000 people (by contrast, the U.S. has 65). In Sierra Leone, a womans lifetime risk of dying during childbirth is 1 in 17. Half of deaths in Uganda could be prevented if emergency care services existed. Here in the United Stateseven though stark health disparities remainmost people dont face these same challenges or lack of options.
So, even as we stand at the pinnacle of vaccinations in the United States, with children as young as five on the precipice of receiving protection, I refuse to accept the growing chasm between countries with resources like ours and every other vulnerable country and person around the world.
It is an unfairand unnecessarydivide.
The World Bank has estimated the cumulative cost of Covid-19 at $16 trillionand counting. In contrast, the International Monetary Fund has estimated the cost to vaccinate every person on this planet at $50 billion.
To be clear, given the choice, every parent should protect their children. I would never argue otherwise. Every family has a right to the safety and security of health that makes education, employment, and opportunity possible. Health is truly fundamental for children to not just survive but to thrive. The problem is that not every family has that option today.
I was raised in a household that emphasized public service, finding ways to courageously address hard challenges, and contributing to those solutions for the greater good. Im raising my own children with values of fairness, service, global citizenship, and a belief in our common humanity.
With innovation, courage, and political will, we can make these values real and translate them into durable change for children in the United States and around the world. We can also cast aside any myopic reasons why such a transformation in health might not be possible: it takes too long; it costs too much; the financial returns are too hard to measure.
Data and the work of many refute these arguments. The World Bank has estimated the cumulative cost of Covid-19 at $16 trillionand counting. In contrast, the International Monetary Fund has estimated the cost to vaccinate every person on this planet at $50 billion. Such investment promises dividends beyond health in development, economic growth, and wellbeing.
The world that every child deserves is not out of reach. Building on the momentum of the Biden Administration convening a Covid-19 summit and world leaders meeting atthe United Nations General Assembly this month, there is a significant opportunity toplace equity and fairnessvalues we should teach our children for a stronger, safer worldat the heart of our global agenda.
Today, parents in certain parts of the world can cheer a closer return to normalcy for their children and communities. Tomorrow, we must move beyond celebration and into action, ensuring that every parent can breathe the same sigh of relief.
Full coverage and live updates on the Coronavirus
When use or disclosure of an individuals health information or medical records is at issue, the assumption seems to be, much more often than not, that the HIPAA privacy and security rules apply. This has certainly been the case during the COVID-19 pandemic. Of course, it is true that in most healthcare settings, HIPAA is the primary law governing the use and disclosure of individually identifiable health information. However, HIPAA is often incorrectly applied in workplace settings.
Today, in an effort to clarify some of these issues as they relate to COVID-19 vaccination data, the Office for Civil Rights (OCR), the agency responsible for enforcing the HIPAA privacy and security rules (the HIPAA rules), issued this guidance. We have summarized some of the key points below.
Do the HIPAA rules prohibit businesses or individuals from asking whether their customers or clients have received a COVID-19 vaccine?
The OCRs answer is clear No.
The HIPAA Privacy Rule does not prohibit any person (e.g., an individual or an entity such as a business), including HIPAA covered entities and business associates, from asking whether an individual has received a particular vaccine, including COVID-19 vaccines.
It is important to remember that the HIPAA rules apply only to covered entities and business associates. In general, covered entities include health plans, health care clearinghouses, and health care providers that conduct standard electronic transactions. But, HIPAA does not apply to entities functioning in their role as employers or to employment records.
The OCR also reminds organizations that even if HIPAA applies, it regulates the use and disclosure of protected health information (PHI), not the ability to request information. Thus, the HIPAA rules do not prohibit a covered entity from receiving COVID-19 vaccination information about an individual. Of course, organizations that receive such information, including employers, still may have a duty to safeguard that information and keep it confidential.
Do the HIPAA rules prohibit an employer from requiring a workforce member to disclose whether they have received a COVID-19 vaccine to the employer, clients, or other parties?
This is a popular question these days. The OCRs answer, No.
OCR reminds readers that the HIPAA rules do not apply to employment records:
including employment records held by covered entities or business associates in their capacity as employers.
The OCR also observed that:
federal anti-discrimination laws do not prevent an employer from choosing to require that all employees physically entering the workplace be vaccinated against COVID-19 and provide documentation or other confirmation that they have met this requirement, subject to reasonable accommodation provisions and other equal employment opportunity considerations.
But, again, once collected, vaccination information must be kept confidential and stored separately from the employees personnel files under Title I of the Americans with Disabilities Act (ADA).
Do the HIPAA rules prohibit a covered entity or business associate from requiring its workforce members to disclose to their employers or other parties whether the workforce members have received a COVID-19 vaccine?
Another popular question and, again, the OCRs answer is no.
The HIPAA rules generally do not regulate what information can be requested from employees as part of the terms and conditions of employment. The following examples from OCR make clear that HIPAA does not prohibit a covered entity or business associate from requiring or requesting each workforce member to:
Do the HIPAA rules prohibit a doctors office from disclosing an individuals PHI, including whether they have received a COVID-19 vaccine, to the individuals employer or other parties?
Here, the answer is generally, yes.The doctors office is a HIPAA covered entity and the HIPAA rules prohibit covered entities from using or disclosing an individuals (patients) PHI except with the individuals authorization, unless an exception applies. Exceptions include, for example, disclosures made for treatment, payment, or health care operations. Absent an exception, the doctors office will need a written authorization in order to disclosure the records.
Note, however, if the physician that owns the practice, while functioning as an employer, has COVID-19 vaccination information about an employee of the practice, the HIPAA rules generally would not apply to prohibit the physician from disclosing that information. But, other laws could apply, such as the ADA.
The OCR provides some additional examples:
Organizations across the country are struggling with COVID-19 related regulations and the impact on their operations screening requirements, vaccination mandates, how to incentivize vaccinations, responding to customer demands for vaccination status information about employees, maintaining adequate staffing levels, arranging for COVID-19 testing, etc. This OCR guidance should help to some degree by clarifying some questions regarding whether an often-cited set of rules the HIPAA rules apply to limit the use and disclosure of information necessary to carry out some of these activities. As explained above, the HIPAA rules often are not applicable.
The Dallas Mavericks are requiring all fans who attend games at the American Airlines Center this season to show proof of full COVID-19 vaccination, or show that they had a negative test taken 48 hours prior to the game, with certain exceptions.
Exceptions exist for children under the age of 12 who are not seated within 15 feet of the court. Since they are not able to be vaccinated they are not required to comply with the vaccine or testing requirements.
However, everyone over the age of 2 must still wear a mask inside the arena unless actively eating or drinking, in accordance with Dallas County's mask mandate.
The team said beginning Oct. 1, fans can upload the desired documents and check-in by following the steps onMavsCheckin.comfor seamless entry into the arena. For those who do not have access to a smartphone, all attendees must bring a printed or digital copy of negative test results or a physical COVID-19 vaccination card.
Connecting you to your favorite North Texas sports teams as well as sports news around the globe.
A list of Dallas County COVID-19 testing facilities can be found here.
The Mavericks said they will have staff at each door of the AAC checking proof of negative tests and vaccination status and that those who are not in compliance will not be allowed in the arena.
Landon Thomas runs the website, MavsFansForLife.com, and says since Thursday's announcement, he's heard from fans on both sides of the issue.
"It's Mark Cuban's responsibility to make sure that Mavs fans are safe inside his house, the AAC, and also keep his investment safe -- protecting the players," Thomas said.
Outside the AAC, fans weighed in on the policy.
"I think thats fine," said Ron Houghton, who told NBC 5 he is vaccinated.
However, his wife Tammy Houghton said she isn't vaccinated yet.
"If I'm not going to get vaccinated, then I'm going to have to do a lot more planning," she said.
Further details can be found on the Mavs' website, on their 2021-2022 Health and Safety Protocols page.
On Wednesday, Mavericks guard Trey Burke told reporters after practice that he has yet to receive the vaccination. According to NBA policies, players who havent received the COVID-19 vaccination will be tested far more often than their vaccinated colleagues and face a slew of other restrictions.
"There's no more unified set of owners than the owners in the NBA and they're all about communicating one message and so the fact that more of them have come out with similar policies as the Mavericks over the last 48 hours is no surprise," said Ray Mallouk, co-founder of Breakaway Sports Marketing in Plano.
The Dallas Mavericks are hosting the annual Fan Jam on Sunday, Oct. 3 at 1 p.m. where fans will get a first look at the complete 2021-2022 Dallas Mavericks team at open practice on the main court. The event will feature the Mavs ManiAACs, Drumline, D-Town Crew and Mascots and is free and open to the public. COVID-19 protocols are in place for this event.
The Mavs' pre-season tip-off is Wednesday, Oct. 6 against the Utah Jazz.
An Instagram post claimedthe COVID-19 vaccine from Pfizer contains an undisclosed mystery ingredient, even though the full ingredient list has been available online since December 2020.
The Sept. 20 post shows a table from the federal Food and Drug Administration titled "composition of COMIRNATY Multiple Dose Vial." Comirnaty is Pfizers brand name for its COVID-19 vaccine.
The table shows the different ingredients that make up the vaccine, according to the Instagram post. However, one of the listed ingredients, described as an excipient, is redacted.
The caption on the post claimed the excipient, a type of inert substance that acts as a vehicle for a drug, makes up 20% of the vaccine and could potentially make up 20% of each dose.
"The undisclosed ingredient is also not disclosed in the vaccine package insert," the post said. "If the American people don't know the identity of an ingredient in an FDA-approved vaccine, how is informed consent possible?"
The post was flagged as part of Facebooks efforts to combat false news and misinformation on its News Feed. Instagram is owned by Facebook. (Read more about our partnership with Facebook.)
Although not all the ingredients of the vaccine were shown in that FDA document, the ingredients of the vaccine are not undisclosed. They have been public since the vaccines came out.
Early version of report
The table featured in the post comes from the FDA as part of a summary report explaining its decision to give final approval to the vaccine. The report includes the studies conducted on the vaccine and an ingredient list.
Although an earlier version of the report had one ingredient redacted, as shown in the Instagram post, the FDA updated the report since the post, removing the redaction.
The formerly redacted ingredient is listed as "water for injection." (A Sept. 30 update to the Instagram post acknowledged the change.)
Pfizers vaccine is distributed in vials of a frozen suspension that must be thawed and diluted with a sterile saline solution of a certain concentration to produce several injectable doses. The table on the FDA report lists the ingredients and their amounts "after dilution."
The package insert for the vaccine lists the ingredients of the suspension and includes the dilution instructions: "Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Do not add more than 1.8 mL of diluent." The insert also details the clinical trials on the vaccine and their findings.
Redactions in FDA reports
Redactions do occur in FDA reports, and are usually for information thats considered a confidential or trade secret, said Alison Hunt, a press officer for the FDA.
The FDA report on Pfizers vaccine still has some redacted information, but Pfizer says it involves "proprietary pieces of the lipid nanoparticle that makes it unique" to the company. Lipid nanoparticles are a type of fatty material that helps transport the vaccine's active ingredient into a person's cells.
Claims that the COVID-19 vaccines contain mysterious or harmful ingredients are not new. They have been checked several times by PolitiFact, and rated False. The ingredients list for the Pfizer, Moderna and Johnson & Johnson vaccines have been available online from the FDA, without redactions, since the vaccines became publicly available.
Our ruling
An Instagram post claimedthe Pfizer COVID-19 vaccine contains an undisclosed ingredient.
The post cited an FDA report in which one of the ingredients listed was redacted. The agency has since updated the file and revealed that the ingredient was water.
Long before the FDA report, the ingredients of the Pfizer vaccine, as well as ones for the Moderna and Johnson & Johnson vaccines, were made public online, without any redactions.
We rate this vaccine claim False.
KANSAS CITY, Mo. Healthcare technology services provider Cerner Corporation announced Friday it will require its employees to receive the COVID-19 vaccine.
The announcement comes on the first day of its new CEO, David Feinberg, taking charge of the company, which is one of the largest private employers in the Kansas City area.
A company spokesperson said all U.S.-based employees will be required to be fully vaccinated as of Dec. 8, 2021.
As part of Fridays announcement, the company delayed its re-entry date to Jan. 10, 2022.
This is a developing story and will be updated.
