FactCheck

A Guide to Johnson & Johnson’s COVID-19 Vaccine

The Johnson & Johnson vaccine is the third COVID-19 vaccine to be authorized by the Food and Drug Administration. Here, we give a rundown of basic facts about the vaccine and an overview of how it works.

Quick Summary

Vaccine name: Ad26.COV2.S

Design type: Adenovirus viral vector 

Dose number: 1 dose

Efficacy: Overall, 66.1% efficacy in preventing moderate to severe COVID-19 in adults 28 days or more after vaccination, but efficacy was higher in the U.S. population (72% efficacy in preventing moderate to severe COVID-19 and 85.9% efficacy in preventing severe or critical COVID-19) than in South Africa (64% and 81.7% efficacy in preventing moderate to severe or severe/critical disease, respectively), where a new strain of coronavirus emerged.

Safety: No serious safety concerns reported. The shot, however, did elicit temporary side effects in some recipients, including pain at the injection site, headache, fatigue, and muscle pain or ache. 

Expected dose availability: Nearly 4 million available immediately in the U.S. upon FDA authorization; 20 million by the end of March and 100 million by the end of June

Expected timeline: On Feb. 27, the FDA authorized the vaccine for emergency use in adults age 18 and older. 

Operation Warp Speed involvement: The U.S. government provided about $1 billion for clinical trials and vaccine development. It spent another $1 billion for vaccine manufacturing, contracting for 100 million doses with an option to purchase up to another 200 million. 

Storage considerations: normal refrigerator temperature (36°F to 46°F) for at least three months; -13°F to 5°F for long-term storage

More than two months after its last COVID-19 vaccine authorization, the FDA authorized for emergency use a one-shot vaccine from Janssen Biotech Inc., a Johnson & Johnson pharmaceutical company, on Feb. 27.

Unlike the Pfizer/BioNTech and Moderna vaccines, which use an mRNA design, the Johnson & Johnson shot uses a harmless adenovirus — a type of virus that typically causes the common cold — modified with the genetic material for SARS-CoV-2 to trigger an immune response. The Johnson & Johnson vaccine has the advantages of being one shot, not two, and being stored at regular refrigeration temperatures for up to three months. The Pfizer and Moderna two-shot vaccines can only be kept at refrigerator temperatures for five or 30 days, respectively.

Johnson & Johnson submitted its request for emergency use authorization on Feb. 4. An external panel advising the FDA met on Feb. 26, and voted unanimously (22 to 0) that “based on the totality of scientific evidence available … the benefits of the Janssen COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older.” The FDA then authorized the vaccine for emergency use the following day.

Johnson & Johnson Q&A What is in the vaccine and how does it work?

The design is different from the mRNA vaccines authorized in December, but all of the vaccines fundamentally work in the same way: They trigger an immune response against the SARS-CoV-2 virus’s spike protein, which sits on the surface of the virus and is what the virus uses to enter cells.

Johnson & Johnson COVID-19 vaccine vials. Photo by Phill Magakoe/AFP via Getty Images

The Johnson & Johnson vaccine uses another, harmless virus — adenovirus 26 — modified with DNA for the SARS-CoV-2 spike protein. Adenoviruses typically cause common-cold symptoms, and for the vaccine, the virus is also modified so it can’t replicate in the body.

The modified adenovirus enters human cells, which then read the genetic material and begin making the coronavirus spike protein. This triggers the immune system, generating protective antibodies and activating other immune cells known as T cells.

In other words, the vaccine doesn’t include the COVID-19 virus, but rather, genetic material that prompts the body to produce an immune response to SARS-CoV-2 so that the body will recognize and react to the actual coronavirus if needed.

Dr. William Schaffner, an infectious disease expert with the Vanderbilt University School of Medicine, summarized how the vaccine works to CNN. “So essentially it’s a sheep in wolf’s clothing, and when your immune system sees it, it responds to it and creates protection against it and in the future, against the real virus that causes Covid-19,” he said.

How was the vaccine developed?

Johnson & Johnson has experience working with adenovirus-based vaccines, and gained approval in Europe in July for an Ebola vaccine that uses this technology.

The company is also working on adenovirus-based vaccines for HIV and Zika.

In January 2020, when the sequence for SARS-CoV-2 became available, Johnson & Johnson collaborated with Harvard’s Beth Israel Deaconess Medical Center to test multiple COVID-19 vaccine candidates. At the end of March, researchers announced they had identified a lead candidate.

In July, J&J launched a phase 1/2a randomized controlled trial in the U.S. and Belgium with 1,051 participants ages 18 to 55 and over 65 to assess dosage, safety and immune response. The company also is conducting a phase 1 trial in Japan and a phase 2a in Germany, Spain and the Netherlands.

After the phase 1/2a trial showed a single dose of the vaccine produced neutralizing antibodies for COVID-19, J&J launched a phase 3 randomized controlled trial of a single dose. It began enrollment in the U.S. on Sept. 21, ultimately enrolling 44,325 people age 18 or older in the U.S., South Africa and six Latin American countries. Enrollment in that trial was complete on Dec. 17. The EUA application is based on the results of that trial, which is ongoing. Participants will be followed for two years.

J&J is also still enrolling participants for a second phase 3 randomized controlled trial in 10 countries, including the U.S., assessing a two-dose regimen. And it has planned future clinical studies of children, pregnant women and their infants, and immunocompromised individuals. 

How effective is the vaccine?

Overall, J&J reported 66.1% efficacy globally in preventing moderate to severe COVID-19 in adults 28 days or more after vaccination, and an efficacy of 85.4% in preventing severe or critical COVID-19. The efficacy was similar across demographics including age, race and ethnicity.

The FDA noted in its briefing document that there were small numbers of participants 75 years and older in the phase 3 trial, creating “limited interpretability” on the efficacy rate for that subgroup, as well as “insufficient” data to assess efficacy in those who had prior SARS-CoV-2 infection.

Moderate to severe disease was defined as a positive COVID-19 test result and either one respiratory-related or deep vein thrombosis symptom, or two symptoms from a list including fever, chills, sore throat, cough, malaise, headache and gastrointestinal upset, the FDA said. A severe/critical case was defined as a positive test result and one symptom including clinical sign of severe systemic illness, respiratory failure, shock, admission to the ICU and death.

As we’ve explained before, a 66.1% efficacy roughly means a vaccinated person has a 66.1% reduced risk of developing moderate disease, compared with a similar person who wasn’t immunized.

Due to new variants of the virus emerging in recent months, J&J provided data on efficacy by location, showing that the vaccine doesn’t appear to be as effective against the B.1.351 variant, which was first observed in South Africa.

In the U.S. population, there was 72% efficacy in preventing moderate to severe COVID-19 and 85.9% efficacy in preventing severe or critical disease, while than in South Africa, those figures were 64% and 81.7%, respectively.

In Brazil, where another variant first emerged, efficacy was closer to that of the U.S. population: 68.1% in preventing moderate to severe disease.

The vaccine had 100% efficacy in preventing COVID-19 that would require medical intervention — meaning hospitalization, ICU admission, mechanical ventilation or a life support machine — 28 days or more after vaccination.

As of Feb. 5, there were no COVID-19-related deaths in the vaccinated group and seven COVID-19-related deaths in the placebo group, the FDA briefing document said.

There may be some efficacy against asymptomatic cases. J&J said preliminary data suggest an effect “based on a limited number of Day 71 results,” but more investigation was needed.

The participants in the vaccinated group who developed moderate symptoms had “fewer and less severe symptoms” than those in the placebo group, J&J said. After 28 days post-vaccination, 66 people developed such symptoms in the vaccinated group, compared with 193 in the placebo group. For severe/critical cases, there were five in the vaccinated group and 34 in the placebo group.

The table below was part of Johnson & Johnson’s briefing document for the Vaccines and Related Biological Products Advisory Committee.

How safe is the vaccine?

There were “no specific safety concerns” identified in the trial, the FDA briefing document said. Some of those receiving the vaccine did report side effects, including injection site pain, headache, fatigue and myalgia (muscle pain or ache), generally lasting a day or two post-vaccination. These side effects were more common in 18- to 59-year-old participants.

Among the 44,325 participants in the phase 3 trial, 21,895 received the COVID-19 vaccine and 21,888 were in the placebo group.

The FDA determined three non-fatal serious adverse events in the vaccinated group were likely related to the vaccine: a hypersensitivity reaction involving urticaria or hives, injection site pain unresponsive to over-the-counter pain medicine, and a case involving a few days of symptoms including “generalized malaise, weakness, myalgia, shortness of breath, headache, sensation of numbness and tingling in upper extremities, chest pain and fever.”

The FDA noted two reports of Bell’s palsy, a form of temporary facial paralysis, in the vaccine group and two in the placebo group, and one case of Guillain-Barre Syndrome in each group. The FDA said those reports “are unlikely related to study vaccine but a causal relationship cannot be definitively excluded.”  

Six vaccine recipients reported deep vein thrombosis, while two placebo recipients did so. Four vaccine recipients reported pulmonary embolism, as did one person in the placebo group. The FDA said there were risk factors among those individuals, but the imbalance between the vaccine and placebo groups meant that “vaccine cannot be excluded as a contributing factor,” recommending surveillance as the vaccine was deployed in larger populations.

There were also more reports of tinnitus, or ringing in the ears, among vaccine recipients: Six reports, compared with none in the placebo group. The FDA again said there was insufficient data to determine a causal relationship to the vaccine, complicated by the fact the individuals had risk factors.

And there were a few cases urticaria, or hives — eight in the vaccine group, three in the placebo group — which the FDA said are “possibly related” to the vaccine.

There were no reports of anaphylaxis immediately after vaccination; however, on Feb. 26, Johnson & Johnson said it had received a report of one such reaction in South Africa.

Editor’s note: This story will be updated as necessary.

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Post Revives Fabricated Image of View from Mars

Quick Take

A computer-rendered image has been mischaracterized on social media posts as a photo taken from Mars, purportedly showing Earth, Venus and Jupiter in vertical alignment. Although the same image was previously debunked in 2012, the claim resurfaced after the Perseverance rover landed on Mars in mid-February.

Full Story

Perseverance, the NASA rover, landed on Mars on Feb. 18. As part of NASA’s multibillion-dollar Mars 2020 mission, Perseverance has been tasked with seeking out “signs of ancient life” and bringing back samples of rock and soil.

Within minutes of landing, Perseverance produced two low-resolution images of the Martian surface. These images sparked a burst of viral posts on Facebook regarding other sights — mostly in jest — showing a McDonald’s and a Dollar General store on the Mars landscape.

On Feb. 21, a Facebook account called AstrophileDaily.com — which says it is “dedicated to sharing latest news in science, especially astronomy, physics and technology” — shared this image, which it claims to depict “Earth, Venus and Jupiter as seen from Mars.” The post has since amassed nearly 2,000 shares, and 3,000 reactions.

But the image and description are deceiving and did not come from the Mars Perseverance mission.

Derrick Pitts, chief astronomer at The Franklin Institute, told us in an email that the photo was “most likely generated from a desktop planetarium program.”

He also directed us to an article from 2012 in Discover Magazine titled “An unreal Mars skyline.”

When NASA’s earlier rover, Curiosity, landed on Mars in August 2012, the same image of Earth, Venus and Jupiter began orbiting on social media. Discover debunked claims about the image, noting various clues that it wasn’t authentic, including the “rendered by software” colors of the sky and landscape.

The article’s author, Phil Plait, wrote: “I have a lot of experience looking at space images, and you just get a sense of what’s real and what isn’t. This one screams fake.” 

The final giveaway is the tiny “NE,” as in northeast, on the lower left corner of the image. Images rendered by planetarium software programs, like Starry Night and SkySafari, include coordinates along the horizon to contextualize the user’s point-of-view, Plait said.

The article concluded, “the picture itself isn’t a hoax! It’s just a computer generated image probably meant to represent a real scene.”

Actual images of Mars from Perseverance are easy to view on the NASA website. See one below:

This panorama, taken on Feb. 20, 2021, by the Navigation Cameras, or Navcams, aboard NASA’s Perseverance Mars rover, was stitched together from six individual images after they were sent back to Earth. Photo by NASA/JPL-Caltech.

 

Editor’s note: FactCheck.org is one of several organizations working with Facebook to debunk misinformation shared on social media. Our previous stories can be found here.

Sources

Achenbach, Joel, et al. “NASA rover Perseverance lands on Mars in mission to search for past life.” Washington Post. 18 Feb 2021.

Derrick Pitts. Chief astronomer, The Franklin Institute. Email sent to FactCheck.org. 24 Feb 2021.

Kaufman, Mark. “Mars Rover Landing a Success—What Happens Now?” National Geographic. 7 Aug 2012.

“Mars 2020 Perseverance Rover.” NASA Science. Accessed 26 Feb 2021.

NASA’s Perseverance Mars Rover. “Hello, world. My first look at my forever home. #CountdownToMars.” Twitter. 18 Feb 2021.

Plait, Phil. “An unreal Mars skyline.” Discover Magazine. 10 Aug 2012.

 

The post Post Revives Fabricated Image of View from Mars appeared first on FactCheck.org.

No Evidence Vaccines Impact Fertility

Q: Do the COVID-19 vaccines cause infertility?

A: There’s no evidence that approved vaccines cause fertility loss. Although clinical trials did not study the issue, loss of fertility has not been reported among thousands of trial participants nor confirmed as an adverse event among millions who have been vaccinated. 

FULL QUESTION

A group of woman in their 20’s I know are not getting the vaccine. They are nurses and teachers. They say that the vaccine can cause infertility. Is this true?

FULL ANSWER

On Feb. 5, the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine and the Society for Maternal-Fetal Medicine released a statement assuring patients that there’s no evidence that the approved COVID-19 vaccines can impact the capacity to conceive children. 

Although there’s limited research on the matter since clinical trials did not specifically study fertility, no related issues have been reported among thousands of trial participants. In fact, some of them got pregnant. Initial studies on animals for the Moderna vaccine showed no impact on female reproduction or fetal development either. And although detecting fertility issues can take time, as of Jan. 20, fertility loss has not been found to be a side effect among millions who have already received the vaccines after authorization, according to the Centers for Disease Control and Prevention. 

“Loss of fertility is scientifically unlikely,” health reproductive experts concluded in their statement.  

The statement was issued to address public anxiety caused by baseless viral claims stating that vaccines can lead to infertility, and even female sterilization. And it reiterates previous recommendations for pregnant patients, as well as those undergoing fertility treatment or planning to conceive. 

“Since the vaccine is not a live virus, there is no reason to delay pregnancy attempts because of vaccination administration or to defer treatment until the second dose has been administered,” according to a document prepared by the American Society for Reproductive Medicine in December.

As we have explained, the two COVID-19 vaccines authorized for use in the U.S. are messenger RNA vaccines, or mRNA, which do not contain a weaker or inactivated version of the virus. The mRNA provides instructions for cells to make their own spike proteins (found on the surface of SARS-CoV-2), prompting the body to generate protective antibodies and activate T cells.

According to the CDC, there is “no risk” of getting COVID-19 from this type of vaccine, and because the mRNA doesn’t enter the nucleus of the cell, it does not affect or interact with a person’s DNA. After making the spike protein, the cells break down the mRNA fairly quickly.

“Given the mechanism of action and the safety profile of the vaccine in non-pregnant individuals, COVID-19 mRNA vaccines are not thought to cause an increased risk of infertility,” recommendations posted on the American College of Obstetricians and Gynecologists website say. 

Dr. Eve C. Feinberg, medical director of Northwestern Fertility & Reproductive Medicine and former president of the Society for Reproductive Endocrinology & Infertility, says there are really two questions when trying to find out the impact of vaccines in fertility: What do we know about the vaccine and fertility, and what do we know about COVID-19 and pregnancy?  

“And I think that we know a lot more about the negative impact of COVID in pregnancy, on both the mother and potentially the fetus, than about the vaccine on fertility. The mechanism of action of the vaccine is such that there really is no biological possibility as to how the vaccine may negatively impact fertility,” Feinberg, who is also a member of the American Society for Reproductive Medicine’s Coronavirus/COVID-19 Task Force, told us. 

Dr. Paul Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia, said people shouldn’t be worried about COVID-19 vaccines causing infertility. He said it is very hard for a vaccine to do something that natural infection doesn’t do, and fertility loss has not been reported even after roughly 67 million people in the U.S. have been infected with SARS-CoV-2, according to antibody surveillance studies. 

“If you know that 20% of the population has been infected with this virus, is there any evidence that we’ve had a decrease in fertility associated with this massive worldwide pandemic? And the answer is, no,” he said in a video. 

Vaccines Do Not Cause Female Sterilization

Multiple false claims tying mRNA vaccines with infertility have been circulating, in both English and Spanish, for months. But among them, a false rumor saying they could cause “female sterilization” by training the body to attack a protein vital for the formation of the placenta has been particularly pervasive. 

The false rumor started with an article titled “Head of Pfizer Research: Covid Vaccine is Female Sterilization” that baselessly stated the “vaccine contains a spike protein… called syncytin-1, vital for the formation of the human placenta” and therefore, the vaccine could form an immune response against that protein, causing infertility. 

Syncytin-1 is an envelope protein, derived from a human endogenous retrovirus, critical in the formation of the syncytiotrophoblast, the outermost layer of the human placenta, responsible for nutrient exchange from mother to embryo. 

But according to researchers, none of the approved COVID-19 vaccines contain syncytin-1.

The story, published on Dec. 2, on a blog called Health and Money News, linked to a petition demanding the European Medicines Agency stop clinical trials on the vaccines for safety concerns. The petition was co-filed by Wolfgang Wodarg, a German physician, and Michael Yeadon, a retired British doctor who worked as a respiratory research employee for Pfizer until 2011, according to his LinkedIn profile. Yeadon had previously claimed the pandemic was “effectively over” in the U.K. and no vaccines were needed. 

According to Wodarg and Yeadon’s petition, syncytin-1 is “also found in homologous form in the spike proteins of SARS viruses,” including SARS-CoV-2. They acknowledge that “[t]here is no indication whether antibodies against spike proteins of SARS viruses would also act like anti-Syncytin-1 antibodies.” But they maintain if it happens, it would cause women to “essentially becoming infertile” by preventing the formation of placenta. 

The false claims were debunked by multiple fact-checkers in December.

In January, a group of independent reproductive health experts published an article in ASRM’s Fertility and Sterility, stating that the vaccine “contains neither syncytin-1 nor the mRNA sequence for syncytin-1.” 

To prove that the SARS-CoV-2 surface glycoprotein, or spike protein, is not “homologous,” or similar in structure, to syncytin-1 protein, as Wodarg and Yeadon claimed, the scientists aligned the amino acid sequences of both proteins using a program that compares nucleotide or protein sequences to sequence databases. Little similarities were found – a finding confirmed by Pfizer.

Eduardo Hariton, a clinical fellow in reproductive endocrinology and infertility at the University of California, San Francisco, and one of the co-authors of the article, told FactCheck.org the researchers published their results after having to constantly reassure worried colleagues, friends and family members that there was no basis to these claims. 

“What they were claiming is that because the COVID spike protein looks like syncytin-1, by training your immune system against the COVID protein, your body would attack syncytin-1. And that is not correct because when you look at the genetic sequences of the spike protein and syncytin-1 there is not that much overlap. So even if that was the case, you would not expect the COVID vaccine to train your body to attack syncytin-1, because they’re just so different,” he said. 

Several scientists have proved the same: The similarities of both proteins are too small for the immune system to be confused by the two. In fact, they are as similar as the spike protein could be to other proteins abundant in the body. Therefore, even if the immune system could be confused, scientists would have already seen related issues in patients who have had COVID-19 or in people who have received the vaccine. That hasn’t happened. Pfizer has said that the spike protein targeted by its vaccine only shared a sequence of four amino acids with syncytin-1, which is made up of 538 amino acids.

“These proteins are extremely divergent and do not look anything like one another,” Alice Lu-Culligan, a medical student and Ph.D. candidate  in the department of immunobiology at Yale School of Medicine, told us. Lu-Culligan co-authored an opinion piece in the New York Times with her professor Akiko Iwasaki debunking Wodarg and Yeadon’s claim as “completely false.” 

In addition to analyzing the amino acid sequence alignments of the coronavirus protein and the syncytin-1 protein, Lu-Culligan and Iwasaki evaluated serum from women with COVID-19. They found no reaction between antibodies for the coronavirus and the syncytin-1 protein. Lu-Culligan, who has been investigating the impact of maternal antiviral responses on fetal development during pregnancy, said that based on the history of vaccines, the plausibility of the COVID-19 vaccines leading to infertility is “extremely unlikely.” 

Other types of vaccines are deemed safe and are recommended to those trying to conceive because they help prevent serious complications during pregnancy. Unvaccinated pregnant individuals who get infected with the flu, for example, are at risk of miscarriage, premature labor, serious lung infection and even death.

With men, experts have observed a short-term impact on sperm count, but Hariton said that’s common for other infections that cause fever.

Should Pregnant or Lactating Women Get The Vaccine?

There’s limited data on vaccine safety for pregnant women because they were excluded from the first clinical trials of both the Pfizer/BioNTech and the Moderna vaccines. So for now, the recommendation for pregnant women is to discuss it with their clinical team and evaluate the risks and benefits of getting vaccinated. 

A health worker administers the Pfizer/BioNTech COVID-19 vaccine to a pregnant woman in Tel Aviv, Israel on Jan. 23. Photo by Jack Guez/AFP via Getty Images.

Pregnant individuals are not more likely to get COVID-19, but they are at increased risk for severe illness and death from COVID-19 than those who are not. According to the CDC, a pregnant COVID-19 patient is more likely to need hospitalization, intensive care unit admission and mechanical ventilation than a COVID-19 patient who’s not pregnant. Pregnant COVID-19 patients also experience preterm birth and other adverse pregnancy outcomes more frequently than healthy expecting parents.

Based on that knowledge, and the way mRNA vaccines work, experts in reproductive health from the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine and the Society for Maternal-Fetal Medicine recommend not withholding vaccines from pregnant and breastfeeding individuals who are eligible, and allowing patients to make their own decision. But they don’t unequivocally recommend them, as they would do with other kinds of vaccines that are proved to be safe. 

What experts know so far is that because mRNA vaccines do not contain the SARS-CoV-2 virus, there’s no risk for the carrier or the infant to get COVID-19. Because the body eliminates the mRNA quickly, it’s unlikely for those particles to reach the placenta. And side effects, such as fever or allergic reactions, are rare but possible. Whether maternal immune response to infection protects the fetus, remains unknown.  

“The risk of getting COVID in pregnancy puts the maternal health and the fetal health at much greater risk than any theoretical risk from vaccination,” said Dr. Feinberg, from ASRM’s Coronavirus/COVID-19 Task Force. 

The World Health Organization guidelines for pregnant individuals are less clear. The WHO states that “we don’t have any specific reason to believe there will be risks that would outweigh the benefits of vaccination for pregnant women” based on the little vaccine safety data available. It says those at high risk of exposure or who have comorbidities “may be vaccinated in consultation with their health care provider.”

According to the CDC, there are no data on the safety of COVID-19 vaccines in lactating women nor on the effects on milk production or the breastfed infant. The recommendation of the Academy of Breastfeeding Medicine is to therefore balance potential risks with potential benefits, even though it says a vaccine is “unlikely to have any biological effects.” 

“During lactation, it is unlikely that the vaccine lipid would enter the bloodstream and reach breast tissue. If it does, it is even less likely that either the intact nanoparticle or mRNA transfer into milk. In the unlikely event that mRNA is present in milk, it would be expected to be digested by the child and would be unlikely to have any biological effects,” a statement on its website reads. 

On the other hand, the ABM says “antibodies and T-cells stimulated by the vaccines may passively transfer into milk” and protect the infant from infection. 

A recent post viewed by over 57,000 people, baselessly claims that the vaccine is causing miscarriages and premature births. The article posted on Feb. 23 by Children’s Health Defense — an organization founded by Robert F. Kennedy Jr., who was banned from Instagram for spreading vaccine misinformation — uses unsubstantiated information attributed to the National Vaccine Information Center, which is not an official government agency, as we have reported before, but an antivaccine organization.

According to the publication, the CDC’s Vaccine Adverse Event Reporting System has received 111 reports of adverse reactions to the vaccine in pregnant individuals. But the story cites data published by MedAlerts, an alternative to VAERS search engine run by the National Vaccine Information Center, not the CDC. In any case, as we’ve explained before, VAERS data is unvetted and raw. Anyone can submit a report, but that doesn’t mean the adverse event or illness can be linked to the vaccines as reports could be incomplete, inaccurate, coincidental or unverifiable.

On Feb. 10, the National Institutes of Health called for greater inclusion of pregnant and lactating people in COVID-19 vaccine research. Reproductive health experts have also advocated to include pregnant individuals in vaccine trials in order to have more data for people to make informed decisions. On Feb. 18, Pfizer and BioNTech announced they would start evaluating their vaccine in pregnant individuals. The goal is to enroll a total of about 4,000 healthy pregnant people in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, U.K. and Spain.

“More research needs to be done, and we are doing that research,” Hariton, who is part of a team at the University of California, San Francisco, conducting a nationwide study on pregnancy and COVID-19, told us. They are trying to recruit 10,000 pregnant individuals. 

“That being said, we don’t know about the long-term effects of COVID and we don’t know about the long-term effects of the vaccine, but it is much more likely that the long-term effects of COVID are going to be much worse than the long-term effects of the vaccines,” he said.

The American College of Obstetricians and Gynecologists’ recommends that pregnant women who choose to get vaccinated should get their shots in authorized sites, complete the two-dose series with the same vaccine product, refrain from getting other vaccines 14 days before and after the COVID-19 vaccine, and to treat any fever following vaccination with acetaminophen.

Editor’s note: FactCheck.org does not accept advertising. We rely on grants and individual donations from people like you. Please consider a donation. Credit card donations may be made through our “Donate” page. If you prefer to give by check, send to: FactCheck.org, Annenberg Public Policy Center, 202 S. 36th St., Philadelphia, PA 19104. 

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Vaccination Considerations for People who are Pregnant or Breastfeeding.” CDC. Updated 12 Feb 2021 accessed 23 Feb 2021. 

Zambrano, Laura D., et. al. “Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020.” CDC. 6 Nov 2020. 

Shaffer, Catherine. “COVID-19 Vaccines for Pregnant Moms May Protect Newborns.” The Scientist. 17 Feb 2021. 

Atyeo, Caroline, et. al. “Compromised SARS-CoV-2-specific placental antibody transfer.” Cell. Volume 184. Issue 3. Feb 2021. 

Coronavirus disease (COVID-19): Vaccines safety.” WHO. 19 Feb 2021.

Considerations for COVID-19 Vaccination in Lactation.” Academy of Breastfeeding Medicine. 14 Dec 2020. 

Robert F. Kennedy, Jr. Announces The Launch of Children’s Health Defense.” Press release. PR Newswire. 12 Sep 2018. 

Herrera, Sebastian. “Instagram Bans Robert F. Kennedy Jr. Over Covid-19 Vaccine Misinformation.” The Wall Street Journal. 11 Feb 2021. 

Spencer, Saranac Hale. “Fake Coronavirus Cures, Part 3: Vitamin C Isn’t a Shield.” FactCheck.org. 12 Feb 2020.

McDonald, Jessica. “Instagram Post Falsely Links Flu Vaccine to Polio.” FactCheck.org. 18 Oct 2019.

VAERS Data.” Vaccine Adverse Event Report System. Accessed 24 Feb 2020. 

NIH calls for greater inclusion of pregnant and lactating people in COVID-19 vaccine research.” Press release. National Institutes of Health. 10 Feb 2021.  

SARS-CoV-2 Vaccination in Pregnancy.” Statement. Society for Maternal-Fetal Medicine. 1 Dec 2020. 

Riley, Laura E., and Brenna L. Hughes. “Pregnant and lactating women should not be excluded from Covid-19 drug, vaccine trials.” Stat News. 28 Sep 2020.

Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women.” Press release. Globe Newswire. 18 Feb 2020.

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Posts Spread Fake Biden Tweet About Coca-Cola, Diversity Training

Quick Take

A popular image is made to appear as if President Joe Biden posted a racist tweet discussing Coca-Cola and “cultural reappropriation.” There is no record of Biden ever posting that tweet.

Full Story

An image circulating on social media is made to look like a tweet from President Joe Biden discussing Coca-Cola and diversity training. But it’s bunk: There is no record of Biden ever tweeting the message in question.

The purported tweet, dated Feb. 21, reads: “I’m proud to see Coca-Cola educate their staff in cultural reappropriation. The disconnect is because the way white people talk leaving minorities confused. Black people communicate a certain way and me and my staff know how those kinds of people talk and it’s time white people learn to do the same #justforthetasteofit #dietcoke.”

But as we said, there is nothing to suggest Biden posted that tweet.

On Feb. 21, we found, his verified @JoeBiden Twitter account — the one used in the bogus screenshot — didn’t post any direct tweets that day. Instead, it only retweeted two posts from the official presidential account, @POTUS, about the late Rep. John Lewis and COVID-19. We also checked a log of deleted tweets from Biden maintained by ProPublica and didn’t find the supposed Coca-Cola tweet there, either.

The bogus screenshot was spread amid allegations that Coca-Cola’s diversity training included a class that contained a suggestion to “try to be less white” — a claim that our fact-checking colleagues at Snopes explored further. The company has issued a statement saying the course in question was not part of its diversity and equity curriculum.

“The training includes access to the LinkedIn Learning platform on a variety of topics, including on diversity, equity and inclusion,” the statement said. “The video in question was accessible on the LinkedIn Learning platform but was not part of the company’s curriculum.”

Users spreading the phony Biden tweet referring to that issue paired it with captions suggesting the tweet was authentic.

One Facebook post was captioned, “So when white people talk blacks can’t comprehend? Interesting…” Text with another post reads, “He sounds like he’s racist.”

Images of made-up tweets are a common form of misinformation. For example, we’ve checked fake tweets that were attributed to Sen. Ted Cruz, former President Donald Trump and Rep. Alexandria Ocasio-Cortez.

Editor’s note: FactCheck.org is one of several organizations working with Facebook to debunk misinformation shared on social media. Our previous stories can be found here.

Sources

Biden, Joe (@JoeBiden). Twitter. Accessed 25 Feb 2021.

Deleted Tweets From Joe Biden, D-D.C.” PolitiWoops. ProPublica. Accessed 25 Feb 2021.

Fichera, Angelo. “Viral Posts Attribute Fake Tweet to Cruz.” FactCheck.org. 19 Feb 2021.

Fichera, Angelo. “Posts Spread Fake Trump Memorial Day Tweet.” FactCheck.org. 27 May 2020.

Hale Spencer, Saranac. “Fake AOC Tweet Politicizes COVID-19 Business Restrictions.” FactCheck.org. 24 Jun 2020.

MacGuill, Dan. “Did Coca-Cola’s Diversity Training Tell Workers ‘Try To Be Less White’?” Snopes. Updated 23 Feb 2021.

Statement on The Coca-Cola Company Diversity, Equity & Inclusion Training.” Press release, the Coca-Cola Company. 20 Feb 2021.

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Biden Hasn’t Reduced COVID-19 Testing at the Border

Quick Take

The Biden administration has made no changes to COVID-19 testing policies for either U.S. Immigration and Customs Enforcement or Customs and Border Patrol. But a claim circulating online falsely suggests that the administration has stopped testing detained immigrants before they are released.

Full Story

A Texas sheriff told Fox News host Tucker Carlson on Feb. 9, “it’s absolutely true” that immigrants detained after crossing the border have been released into the U.S. without being tested for COVID-19.

The sheriff, A.J. Louderback, then cited and misrepresented a memo issued by David Pekoske, acting secretary of the Department of Homeland Security, on the first day of President Joe Biden’s term.

That exchange was highlighted in a story on a conservative website, The Political Insider, with the headline: “Texas Sheriff Claims Biden Admin Releasing Illegal Immigrants Into U.S. Without COVID Testing.”

It’s true that Louderback made the claim — but the claim itself is false.

Despite that, the headline still garnered comments on Facebook calling for Biden to be impeached or charged with either murder or attempted murder.

In reality, the Biden administration has maintained the same procedures for COVID-19 testing in detention facilities that were in effect during the previous administration.

Nothing in the Biden administration’s policy indicates a break from the standing policy on COVID-19 testing, Josiah Heyman, director of the Center for Interamerican and Border Studies at the University of Texas at El Paso, told us in a phone interview.

Both U.S. Immigration and Customs Enforcement and Customs and Border Patrol confirmed to us that no such policies had changed.

Louderback didn’t specify on Carlson’s show which agency was no longer conducting testing, but he did say that the effect of the memo was to “defund ICE,” so he left the impression that he was talking about ICE.

It’s worth noting, though, that Louderback doesn’t work for either ICE or CBP — he’s the sheriff in Jackson County on the gulf coast of Texas. Louderback told us in an interview that he became vocal about immigration issues while former President Barack Obama was in office. He was invited to the White House at least twice for immigration-related appearances under former President Donald Trump.

Both ICE and CBP are part of the Department of Homeland Security, and the memo that Louderback referenced called for a review of policies in each agency.

“The United States faces significant operational challenges at the southwest border as it is confronting the most serious global public health crisis in a century,” Pekoske’s memo said. “In light of those unique circumstances, the Department must surge resources to the border in order to ensure safe, legal and orderly processing, to rebuild fair and effective asylum procedures that respect human rights and due process, to adopt appropriate public health guidelines and protocols, and to prioritize responding to threats to national security, public safety, and border security.”

It also specified that “all enforcement and detention decisions shall be guided by DHS’s ability to conduct operations and maintain custody consistent with applicable COVID-19 protocols.”

For ICE, those protocols, which were in effect when Biden took office, include testing all detainees upon arrival and then keeping them quarantined for 14 days while monitoring for COVID-19 symptoms. “New arrivals who have negative test results and remain symptom free can join the general detained population after the 14-day intake period. Detainees who test positive for COVID-19 receive appropriate medical care to manage the disease,” according to the agency’s guidance, which was last updated Aug. 12, 2020.

Also, the ICE manual for dealing with COVID-19 says that high-risk detainees must be tested before being released into the community.

CBP is supposed to limit its detentions to 72 hours and, according to a spokeswoman who answered our questions by email, officers “conduct initial inspections for symptoms or risk factors associated with COVID-19 and consult with onsite medical personnel, the U.S. Centers for Disease Control and Prevention (CDC), or local health systems as appropriate. Onsite medical personnel can provide basic assessment and supportive treatment, but suspected COVID-19 cases are referred to local health systems for appropriate testing, diagnosis, and treatment.”

Again, this was the existing protocol when Biden took office.

When we asked Louderback to clarify his claim, he didn’t directly address the suggestion he had made on the show. Instead, he focused on the recent change to the Migrant Protection Protocols, better known as the “remain in Mexico” policy that was introduced by the Trump administration in 2019. Under that policy, asylum seekers were sent to Mexico to await their court appearances in the U.S.

The Biden administration has stopped enrolling people in the program and started processing the roughly 25,000 people currently waiting in Mexico.

The policy for processing them includes testing each individual in Mexico before they enter the U.S.

Louderback also suggested in the phone interview that another Trump-era policy was no longer in effect. “Title 42 was left out,” he said, referring to an order from the CDC that permits border patrol officers to send back immigrants in order to slow the spread of COVID-19. Louderback suggested that the order provided testing related to the MPP and, since it wasn’t mentioned in the memo from Pekoske, it was no longer in effect.

None of that is true.

Title 42 doesn’t address testing and it’s still in effect. Biden directed the CDC to review and evaluate the necessity of the order in his Feb. 2 executive order on immigration policy, but he didn’t end its use. Some Democrats have called on him to do so, while some Republicans have called on him to leave it intact. In January, the month Biden took office, more than 60,000 people were rejected at the Mexican border under the order, which is roughly the same number that were rejected in each of the previous three months, according to the most recent numbers from CBP.

Acknowledging that reduced testing isn’t mentioned in the memo, Louderback said in the phone interview, “Reality is, whether or not it’s mentioned in there, there is no testing being done.”

But Heyman, of the University of Texas at El Paso, said, “If there are people who haven’t been tested, it’s a breakdown on the behavior of ICE, not Biden administration policy.”

Editor’s note: FactCheck.org is one of several organizations working with Facebook to debunk misinformation shared on social media. Our previous stories can be found here.

Sources

Texas sheriff claims Biden has ‘defunded ICE by memorandum.’” Foxnews.com. 9 Feb 2021.

Noble, Becky. “Texas Sheriff Claims Biden Admin Releasing Illegal Immigrants Into U.S. Without COVID Testing.” Thepoliticalinsider.com. 9 Feb 2021.

Heyman, Josiah. Director, Center for Interamerican and Border Studies at the University of Texas at El Paso. Telephone interview. 15 Feb 2021.

Spokesperson, U.S. Immigration and Customs Enforcement. Email exchange. 12 Feb 2021.

Spokesperson, U.S. Customs and Border Patrol. Email exchange. 23 Feb 2021.

Louderback, A.J. Sheriff, Jackson County, Texas. Telephone interview. 16 Feb 2021.

Pekoske, David. Memorandum — Review of and Interim Revision to Civil Immigration Enforcement and Removal Policies and Priorities. U.S. Department of Homeland Security. 20 Jan 2021.

U.S. Department of Homeland Security. ICE Guidance on COVID-19. Accessed 23 Feb 2021.

U.S. Department of Homeland Security. “COVID-19 Pandemic Response Requirements.” 27 Oct 2020.

U.S. Department of Homeland Security. Migrant Protection Protocols. 24 Jan 2019.

U.S. Department of Homeland Security. DHS Statement on the Suspension of New Enrollments in the Migrant Protection Protocols Program. 20 Jan 2021.

Biden, Joe. Executive Order on Creating a Comprehensive Regional Framework to Address the Causes of Migration, to Manage Migration Throughout North and Central America, and to Provide Safe and Orderly Processing of Asylum Seekers at the United States Border. 2 Feb 2021.

U.S. Department of Homeland Security. Press release. “DHS Announces Process to Address Individuals in Mexico with Active MPP Cases.” 11 Feb 2021.

U.S. Department of Homeland Security. DHS Begins to Process Individuals in MPP Into the United States to Complete their Immigration Proceedings. Accessed 23 Feb 2021.

Lavandera, Ed, Ashley Killough and Kim Berryman. “There’s an uptick in migrants crossing into the US, driven by economic woes and hopes for change under Biden.” CNN.com. 19 Feb 2021.

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