Gates’ Investment in Startup Firm Is Not Related to Baby Formula Shortage

Quick Take

A fund backed by Bill Gates has invested in a startup working to develop lab-manufactured breast milk, but it won’t reach the market for several years. Yet, social media posts make baseless claims that Gates is behind the current baby formula shortage — which stems from supply-chain issues and the shutdown at a major manufacturing plant.

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Breakthrough Energy Ventures, a fund backed by Bill Gates that invests in climate-friendly technologies, in 2020 led a $3.5 million round of financing for BIOMILQ, a startup working on reproducing human breast milk using mammary cells.

The company’s product hasn’t yet made it to market — a June 2021 blog post noted that “we’re only in our first trimester.”

But the two-year-old investment is being cited in social media posts to make unfounded claims that Gates engineered the current baby formula shortage because he is invested in a rival product.

The shortage is actually due to supply-chain constraints exacerbated by a major manufacturer’s recall and plant shutdown, as we’ve reported, and there’s no evidence Gates or Breakthrough Energy Ventures is related to it.

Breakthrough “invested in BIOMILQ as a low-carbon alternative to dairy production,” a company spokesperson told FactCheck.org in an email. The claim that the fund is behind the formula shortage “is false,” she said.

CNN, in a report earlier this month, said BIOMILQ is at least three years away from commercial availability.

Gates is chair of Breakthrough Energy Ventures, which counts high-profile investors Jeff Bezos, Richard Branson and Michael Bloomberg among its board members. The fund is part of Breakthrough Energy, which funds technologies with the goal of reaching net-zero emissions by 2050.

A frequent target of conspiracy theories, Gates is again being falsely blamed for a national crisis.

One tweet said Gates “has been investing heavily in synthetic soy breast milk.” The tweet, from an account called LivePDDave, goes on to ask two leading questions: “He wouldn’t have anything to do with the baby formula shortage, would he? Create a problem (like Covid) and then step in with a ‘solution’?” The second question could be a reference to any number of false claims about Gates, including the debunked claim that he plotted to create the pandemic in order to depopulate the world through vaccines.

The baby formula claim is also making the rounds on Facebook, with one post falsely claiming Gates has already opened a “synthetic breastmilk plant.” 

Another widely shared post misleadingly questions the timing of events. “Pfizer says do not breast feed. Baby formula runs scarce. Bill Gates promotes new artificial breast milk technology. All within 2 weeks.”

Conservative commentator Candace Owens repeated the claim. “Doesn’t Bill Gates have the best luck?” she tweeted. “Just like with the COVID vaccine — he makes an investment, and then suddenly there is a pandemic or shortage and everyone must line up for his product. Of course he’s invested in lab breast milk!”

But as we’ve written, the U.S. shortage of baby formula has been driven largely by a product recall and subsequent plant shutdown by Abbott Nutrition, a major manufacturer of formula, and ongoing supply-chain issues exacerbated by the COVID-19 pandemic, according to experts.

Abbott Plant Cleared to Restart

Abbott said on May 16 that it reached an agreement with the Food and Drug Administration to take steps to resume production, and formula shipments could resume six to eight weeks later. House Democrats, meanwhile, introduced legislation that would provide $28 million to help the FDA boost staffing and avoid future shortages.

Abbott in a May 13 blog post acknowledged its role in the baby formula shortage. “We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can,” the company said. Abbott said it has shipped “millions of cans” from a facility in Ireland as it works to address FDA concerns and restart operations at the Michigan plant.

The nationwide out-of-stock percentage for baby formula stood at 43% in the week ended May 8, up from 2% to 8% in the first half of 2021, according to pricing provider Datasembly. At the end of April, the figure was 40%.

‘Perfect Storm’ Created Crisis

The shortage is the result of a “perfect storm of multiple factors,” said Jason Miller, associate professor of logistics at Michigan State University’s Eli Broad College of Business.

Only a handful of plants in the U.S. make baby formula, with four companies accounting for about 45% of industry shipments, Miller told us in a phone interview, citing government data. That means “any large plant shutting down causes issues.”

Moreover, “these plants turn inventory very quickly,” so there’s not much stock on hand in the event something happens, Miller said. Once people realized there was a shortage of formula, there was probably some “hoarding,” similar to the toilet-paper situation in the early days of the pandemic, he said. “All of a sudden, you have a recipe for shortfalls like we’re seeing,” he said.

The shortage is likely to last awhile even after the Abbott plant reopens, Miller said. “Americans have to understand this isn’t a product you just throw in a vat and magically it’s produced in two hours,” he said. “There are numerous quality checks conducted repeatedly.”

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. Facebook has no control over our editorial content.


Roy, Aditi. “Altbreastmilk company Biomilq raises $3.5 million from Bill Gates’ investment firm.” CNBC. 16 Jun 2020.

Breakthrough Energy Ventures press office. Email to FactCheck.org, 17 May 2022.

Chan, Milly. “Lab-grown ‘Human Milk’ May Be Just Three Years Away.” CNN. 3 May 2022.

Fichera, Angelo. “Video Targets Gates With Old Clip, Misleading Edit.” FactCheck.org. 5 Mar 2021.

Fichera, Angelo. “New Coronavirus Wasn’t ‘Predicted’ in Simulation.” FactCheck.org. 29 Jan 2020.

Datasembly. Press release. “Nation-wide Out-Of-Stock is now at 43% for the week ending May 8th.” 10 May 2022.

Abbott Labs. Press release. “Abbott Enters Into Consent Decree With U.S. Food and Drug Administration for Its Sturgis, Mich., Plant; Agreement Creates Pathway to Reopen Facility.” 17 May 2022.

House Appropriations Committee. Legislation. “Making emergency supplemental appropriations to address the shortage of infant formula in the United States for the fiscal year ending September 30, 2022, and for other purposes.” 17 May 2022.

 Abbott Labs. Newsroom: Nutrition, Health and Wellness. “Abbott Provides Infant Formula Update.” 13 May 2022. 

 Reuters Fact Check. “Fact Check-Bill Gates Investment in Lab-Produced Breast Milk Company is Unrelated to Baby Formula Shortage, Contrary to Posts Online.” 13 May 2022.

 Miller, Jason. Associate professor of logistics, department of supply chain management, Michigan State University Eli Broad College of Business. Phone interview with FactCheck.org. 17 May 2022.

 Whyte, Liz Essley. “FDA Eases Baby-Formula Import Rules to Boost Supplies.” Wall Street Journal. 16 May 2022.


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Plan B Pills Still Legal in Tennessee and Missouri, Contrary to Social Media Claims

Quick Take

Proposed legislation in Tennessee and Missouri would not regulate Plan B contraception pills, and experts say state “trigger laws” that would take effect if Roe v. Wade were overturned will not ban methods of birth control. But social media posts falsely claim that both states have banned Plan B – the morning-after pill.

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A leaked Supreme Court draft opinion published on May 2 by Politico indicated that the court could vote to overturn the 1973 Roe v. Wade ruling establishing a constitutional right to an abortion. Chief Justice John Roberts confirmed the authenticity of the leak but said the draft ruling does not represent the court’s final decision.

Abortion rights advocates and anti-abortion protesters demonstrate in front of the Supreme Court on Dec. 1, 2021. Kent Nishimura / Los Angeles Times via Getty Images.

“We hold that Roe and Casey must be overruled,” Justice Samuel Alito wrote in the document. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

As we wrote, jurisdiction would then go back to the states, likely setting up a patchwork of abortion restrictions and rights across the country.

Meanwhile, the leaked court opinion has sparked misleading interpretations and false claims, including concerns over what “trigger laws” surrounding abortion will entail in several states. A “trigger law” refers to legislation that exists but cannot be enforced unless specific circumstances are met or changed.

Several posts on social media falsely claim that Plan B contraceptive pills have been banned or will be banned through new abortion legislation in Tennessee and Missouri. 


Another Facebook post claims, “Tennessee banned plan b’s we can’t never have nice sht here.”

One Facebook post shifts the focus to Missouri, claiming, “They just banned plan B’s in Missouri. Clearly I don’t use em but y’all be easy.” 

But neither Tennessee nor Missouri bans Plan B. Although both states recently passed or advanced legislation restricting access to abortions and abortion pills, Plan B was not included in the laws. The pills are still legal and available and won’t be affected by current bills. 

The abortion pill — which is different than Plan B — is a safe and effective way to end an early pregnancy using the drugs mifepristone and misoprostol.

Plan B, also known as the morning-after pill, is an emergency contraceptive used to prevent pregnancy for women who’ve had unprotected sex or whose birth control method has failed, according to the Mayo Clinic. Morning-after pills contain either levonorgestrel or ulipristal acetate.

Tennessee Restricts Abortion Pill, Not Plan B

There are 13 states — including Missouri and Tennessee — that have passed trigger laws to ban abortion if Roe is overturned. 

Tennessee’s trigger law, the “Human Life Protection Act,” passed in 2019, makes abortion illegal and a felony for doctors to perform, while women seeking abortions would be exempt from prosecution. 

On May 5, Republican Gov. Bill Lee signed into law House Bill 2416, or the “Tennessee Abortion-Inducing Drug Risk Protocol Act.” That act replaces Tennessee’s current law restricting abortion pills to use only under the physical supervision of a doctor. The act requires medical clinicians to follow a list of procedures set forth in the bill, including being physically present when abortion pills are administered to a patient — even though federal regulations allow mail delivery nationwide. Federal regulations allow the pills to be sent by mail in any state that doesn’t prohibit the practice.

The delivery of abortion pills by mail is outlawed in Tennessee under the new law. Those who would like to use the pills would be required to visit a doctor in advance, then wait 48 hours before taking the pills under the doctor’s supervision.

The law goes into effect on Jan. 1, 2023. It classifies the offense as a Class E felony and, upon conviction, physicians who violate the law may be fined up to $50,000. The legislation also says “criminal penalty will not be assessed against a patient upon whom a chemical abortion is attempted or performed.”

Laura Hermer, a professor at the Mitchell Hamline School of Law in St. Paul, Minnesota, who has expertise in reproductive rights, abortion and public health, told us in a phone interview that the language in the Tennessee bill doesn’t indicate that Plan B would be banned in that state.

“Plan B prevents an egg from implanting in the uterus. This all happens before pregnancy can be actually confirmed. When [the bills] are talking about abortion, they are talking about a clinically diagnosable pregnancy,” Hermer said.

“Plan B is taken within 72 hours of actually having sex. You can’t be diagnosed with pregnancy at that point, it’s not possible. Later in the text of the bill (HB 2416), they mention a physician must independently verify that a pregnancy exists. Again, that’s simply not possible at [the point one would use a Plan B pill],” she added. “To say that the Plan B pills would be or should be included in the bills would be wrong. That would be a fallacy.”

Missouri Bill Doesn’t Regulate Contraception

On May 10, a Missouri Senate Committee advanced a resolution that would ban all abortions in the state, except in the case of a medical emergency, if Roe v. Wade were overturned. The law has no exception for rape or incest.

On May 10, a Missouri Senate Committee advanced a resolution that would enact a trigger law passed in 2019 banning abortion if Roe v. Wade were to be overturned. The law allows an exception for “cases of medical emergency.” The law also makes it felony to perform an abortion, but specifies that a person seeking an abortion wouldn’t be prosecuted.

The resolution refers to Section 188.017, cited as the “Right to Life of the Unborn Child Act,” of House Bill 126, also known as the “Missouri Stands for the Unborn Act” — a trigger law passed in 2019 that bans abortions after eight weeks of pregnancy and makes inducing an abortion a Class B felony. A Class B felony is punishable by five to 15 years under Missouri law. Women seeking abortions would be exempt from prosecution. 

Two other bills, Missouri House Bill 2810 and its Senate counterpart, Senate Bill 1178, were introduced to “modify provisions relating to abortion.” The bills would make it a Class B felony for a person or entity to commit the offense of trafficking abortion-inducing devices or drugs. 

But the Missouri bills do not mention Plan B or any other form of contraception, according to a legal expert and pro-choice advocacy groups.

Sidney Watson, director of the Center for Health Law Studies at Saint Louis University School of Law, explained to us in an email that Missouri’s abortion law “does not regulate methods of contraception like Plan B.”

“Missouri’s 2019 abortion law, House Bill 126, has a trigger provision that immediately goes into effect if the governor or the attorney general certify that Roe v Wade has been overturned. HB 126 regulates abortion, the termination of a pregnancy,” explained Watson. “It does not regulate methods of contraception like Plan B, which prevent pregnancy. The law specifically defines abortion as ‘termination of the pregnancy.'”

“I think some commentators are confused because HB 126 also contains a very broad definition of conception as occurring when ‘the fertilization of the ovum of a female by the sperm of a male.’ However, courts have interpreted this as a values statement not as controlling on the issue of what constitutes an abortion,” Watson said. 

Pro-Choice Missouri, a pro-choice advocacy organization, tweeted, “Just the facts: Current Missouri abortion law does NOT jeopardize #BirthControl (like IUDs), Emergency Contraception (EC or ‘Plan B’) or fertility care (IVF), and neither do any of the bans we’re currently watching in #MoLeg.”

“Birth control does not meet the criteria for the definition of abortion under MO law,” tweeted a Planned Parenthood based in St. Louis. “Since birth control prevents pregnancy (and does not end an existing pregnancy), overturning #Roe will not block access to birth control.”

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. Facebook has no control over our editorial content.


Anderson Cooper 360 Degrees: Interview With Rep. Pramila Jayapal (D-WA).” CNN. 4 May 2022. 

Anderson Cooper 360 Degrees: Interview With Rep. Cori Bush (D-MO).” CNN. 3 May 2022. 

Boundless Resources. “Trigger laws.” Accessed 12 May 2022.

The Lead with Jake Tapper: Rep. Barbara Lee (D-CA).” CNN. 3 May 2022.

Gerstein, Josh and Alexander Ward. “Supreme Court has voted to overturn abortion rights, draft opinion shows.” Politico. 2 May 2022.

Hermer, Laura. Professor, Mitchell Hamline School of Law. Phone interview with FactCheck.org. 13 May 2022. 

Kiely, Eugene and Lori Robertson. “What Happens if Roe v. Wade Is Overturned?” FactCheck.org. Updated 5 May 2022.

Mayo Clinic. “Morning-after pill.” Accessed 12 May 2022.

Missouri Senate. “Rules, Joint Rules, Resolutions and Ethics.” Senate.mo.gov. Accessed 12 May 2022.

Missouri State Legislature. “MO HB126: Missouri Stands for the Unborn Act.” Legiscan.com. (as passed by the House 24 May 2019.)

Missouri State Legislature. “188.017. Right to Life of the Unborn Child Act.” Revisor.mo.gov. (as passed by the House 24 May 2019.)

Missouri State Legislature. “Senate Bill 1178.” Legiscan.com. Accessed 13 May 2022. 

Luthra, Shefali. “Republican state lawmakers prepare to quickly limit abortion access if Roe v. Wade is overturned.” The 19th Newsletter. 9 May 2022.

Laura Hermer” webpage. Mitchell Hamline School of Law. Accessed 12 May 2022.

Pelzer, Jeremy. “Gov. Mike DeWine: Ohio will seek to revive ‘heartbeat bill’ if Supreme Court overturns Roe v. Wade.” Cleveland.com. 4 May 2022.

Planned Parenthood. “The Abortion Pill.” Accessed 12 May 2022.

Planned Parenthood (@PPSLR). “Birth control does not meet the criteria for the definition of abortion under MO law. Since birth control prevents pregnancy (and does not end an existing pregnancy), overturning #Roe will not block access to birth control.” Twitter. 5 May 2022. 

Robertson, Lori, et al. “What Gorsuch, Kavanaugh and Barrett Said About Roe at Confirmation Hearings.” FactCheck.org. 9 May 2022.

Silva, Marina. “Missouri Senate committee passes resolution if Roe v. Wade is overturned.” KY3. 10 May 2022. 

Suntrup, Jack. “Missouri Senate committee advances resolution to trigger abortion ban when Roe is overturned.” St. Louis Post-Dispatch. 10 May 2022. 

Tennessee Advocates for Planned Parenthood. “Let’s Talk About Tennessee’s Trigger Laws.” Planned Parenthood. 14 Feb 2022.

Tennessee State Legislature. “TN HB2416: Tennessee Abortion-Inducing Drug Risk Protocol Act.” Legiscan.com. (as passed by the House 9 May 2022.)

Tennessee State Legislature. ” TN SB1257: Human Life Protection Act.” Capitol.tn.gov. (as passed by the Senate 22 May 2019.)

The Lead with Jake Tapper: Rep. Barbara Lee (D-CA).” Transcript. CNN. 3 May 2022.

Watson, Sidney. Director, Center for Health Law Studies at Saint Louis University School of Law. Email sent to FactCheck.org. 17 May 2022.

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Misleading Late Attack on Kathy Barnette in Pennsylvania Senate Race

A late attack ad from a super PAC supporting one of Kathy Barnette’s opponents in the Pennsylvania Senate Republican primary makes several misleading claims about Barnette, who has surged in the polls.

  • The ad highlights a Barnette tweet with the hashtags “#BLM #DefundThePolice” to claim she “holds extreme views on race.” But the tweet linked to a video that clearly stakes out Barnette’s opposition to the Black Lives Matter and defund the police movements.
  • The ad says Barnette supported the George Floyd protests, while misleadingly showing images of protesters starting fires — the very kind of violence that Barnette repeatedly denounced in a video cited in the ad.
  • The ad says Barnette “supported a law that released criminals from prison,” without disclosing that the law, known as the First Step Act, was championed and signed by then-President Donald Trump.

Released just days before the May 17 primary, the attack ad against Barnette was created by Honor Pennsylvania, a super PAC supporting one of Barnette’s Republican opponents, Dave McCormick. Although Honor Pennsylvania’s ads have mostly targeted McCormick’s chief opponent, Dr. Mehmet Oz, recent polling shows Barnette has moved into a statistical tie with Oz and McCormick.

The ad concludes, “Conservatives can’t trust Kathy Barnette.” But the points on which it bases that conclusion are misleading.

https://cdn.factcheck.org/UploadedFiles/USSEN_PA_HONORPA_CANT_TRUST.mp4 Barnette on Black Lives Matter

The narrator in the ad says Barnette, who is Black, “holds extreme views on race.” On screen the ad shows a July 14, 2020, tweet from Barnette that reads “#BLM #DefundThePolice.”

#BLM #DefundThePolice https://t.co/M2HprniiXa

— Kathy Barnette (@Kathy4Truth) July 14, 2020

But as Twitter explains, hashtags do not connote support, but rather, “Including a hashtag gives your Tweet context and allows people to easily follow topics that they’re interested in.” And indeed, those are the topics discussed in a video Barnette attached to her tweet. But as she makes clear, contrary to supporting, she vehemently opposes Black Lives Matter and defund the police.

“Defunding the police is stupid, people,” Barnette says in the video. “Abolishing the police is stupid, people. Black people, do not fall for the okey doke. Do not fall for these white liberals who are coming into our communities and telling us we need to remove law enforcement.”

“Black Lives Matter global network incorporated does not care about my Black life,” Barnette says. “It does not care about the Black lives of those who are just trying to work, who are trying to provide for their family, who are keeping their nose clean, who just want to be able to take their Black child across the street to the park with the rest of their Black family.”

“Democrats, I know all of you cannot be falling for this stupidity that Black Lives Matter global network incorporated is really trying to improve the lives of Black people.”

Barnette on Floyd Protests

The ad goes on to say that Barnette “supported the George Floyd protests.” As the narrator says this, the ad shows an image of protesters starting a fire.

To back up its claim, the ad cites a May 31, 2020, video Barnette posted on YouTube in which she discusses Floyd, a Black man killed by a white police officer who kneeled on his neck during an arrest in Minneapolis a week earlier on May 25, 2020, and the protests the killing sparked around the nation.

In the video, Barnette says, “What happened to George Floyd should never happen to anyone. It is indefensible what was done.” And, she said, she would have protested alongside people in Minnesota seeking justice for Floyd.

“I, like you, wanted to make sure that … George Floyd received justice, and that these four police officers did not get a tap on the wrist,” Barnette said. “I wanted that just like everyone else in this nation. And I can say for a strong certainty that I would have been out there right along beside each and every one of you who were protesting in Minneapolis. I would have been right there. Lock arm and ready to have my voice heard, to make sure that those who are in power recognize that we are watching them and what our expectations are. I would have been right there.”

She said the national response was “a wonderful show of a nation coming together and condemning something that we all found to be reprehensible.”

However, she said what “honestly started as a protest, and for very good reason” was co-opted by white liberals, and descended into rioting, looting and fire-starting, which she said she vehemently opposed.

“Let me tell you something, rioting has nothing to do with honoring George Floyd’s death, or memory,” Barnette said. “Looting has nothing to do with honoring the memory of George Floyd. Creating chaos, assaulting people, destruction, vandalism, setting police cars on fire, running over a police department has absolutely nothing to do with honoring George Floyd’s memory. Absolutely nothing.”

Barnette said she also does not believe police violence against Black people is systemic.

“Listen, there is a reason why many Black Americans feel disenfranchised in America,” Barnette said. “And I will never try to minimize the reasons why many of them feel that way. And yet a lot of what we see is manipulation. It’s the stoking of the flame of the tensions of the history of this nation. For example, many are saying today that what we are experiencing — what happened to George, George Floyd — is systemic racism in our justice system, specifically among police officers. They would have us to believe that there is a police officer like Officer Chauvin, who had his knee on George Floyd’s neck, around every street corner. And that everywhere we go, there is a police officer waiting to shoot a Black man. I reject that. And I don’t reject it because I feel like that’s not true. I reject it because it is — statistically is not true.”

Barnette Supports First Step Act

Finally, the ad says Barnette “supported a law that released criminals from prison, including the release of prisoners convicted on weapons charges, sex offenses and homicide.”

The ad cites a July 23, 29109, Fox News story, without making clear it is a reference to Barnette’s support for the First Step Act of 2018 — a bill championed and signed into law by Trump.

The law seeks to reduce the size of the federal prison population through sentencing changes, while maintaining public safety. It received bipartisan support and was hailed by Trump as “groundbreaking criminal justice reform” that he boasted Democrats were not able to get passed. The Senate passed the bill 87-12. While 12 Republicans opposed the bill, and Sen. John Kennedy later claimed that it led to the early release of some violent criminals, it enjoyed overwhelming support from Senate Republicans, including — as Trump noted — conservative senators such as Ted Cruz, Mike Lee and Chuck Grassley.

Immediately after making the claim about Barnette’s support for Trump’s policy, the Honor Pennsylvania ad says, “And if that wasn’t crazy enough, Barnette even opposed Donald Trump.”

In her book, “Nothing to Lose, Everything to Gain: Being Black and Conservative in America,” Barnette acknowledges that she did not support Trump in the 2016 Republican presidential primary.

“In all honesty, I was not a Trumper initially,” Barnette wrote. “With the likes of former governor Mike Huckabee, neurosurgeon Ben Carson, and Senator Ted Cruz, there was no way on God’s green Earth I was intending to vote for the television and business mogul. We had just too many ‘good’ options to resort to voting for him. Out of the sixteen presidential candidates, Donald Trump was number 16 on my preferred list.”

Barnette said she did not vote for Trump in the Republican primary, but “by the time the general election rolled around I was firmly on the first car of the Trump train.”

The candidates in the Pennsylvania race are seeking to fill the Senate seat being vacated by Republican Sen. Pat Toomey. Trump has endorsed Oz and has criticized Barnette as being unelectable in the general election.

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Pfizer Documents Show Vaccine Is Highly Effective, Contrary to Social Media Posts

SciCheck Digest

The Pfizer/BioNTech COVID-19 vaccine showed a final efficacy of 91% against symptomatic illness in its phase 3 trial. Social media posts wrongly claim recently released Pfizer documents show the vaccine is “12% effective.” That appears to be a misreading of data released more than a year ago.

How effective are the vaccines? How effective are the vaccines?

All of the authorized and approved vaccines are effective at preventing severe COVID-19.

Against earlier forms of the coronavirus, the vaccines were highly effective at preventing symptomatic illness. For example, the Pfizer/BioNTech vaccine, which was the first COVID-19 vaccine to receive full approval from the Food and Drug Administration, showed a final efficacy of 91% against symptomatic illness in its phase 3 trial, meaning that under the conditions of the trial the vaccine reduced the risk of getting sick by 91%.

The Moderna vaccine showed similar results in its clinical trial, with a final efficacy of 93%. It has also received FDA approval.

Johnson & Johnson, which partly tested its vaccine in South Africa when the beta variant emerged, reported an efficacy of 66% in preventing moderate to severe COVID-19 and an efficacy of 85% in preventing severe or critical COVID-19 in its clinical trial.

Subsequent studies have demonstrated that the vaccines are effective under real-world conditions, including against the highly contagious delta variant. Against omicron, however, the vaccines haven’t fared as well and are much worse at preventing infection or mild disease. The shots are still good at preventing hospitalization or death, though, particularly if someone has received a booster dose.

Booster shots are recommended for most people, as these increase and prolong protection against severe disease and also provide some temporary protection against infection and milder illness. For instance, a Centers for Disease Control and Prevention study found that during the omicron wave, adults who had received two doses of the Pfizer/BioNTech or Moderna vaccines had a 79% lower risk of dying or needing a ventilator if hospitalized with COVID-19, compared with unvaccinated adults. Those who had received a booster vaccine dose as well had a 94% lower risk. 

People over the age of 50 and people who are immunocompromised are also eligible for a second mRNA booster.

Link to this

Full Story

The Pfizer/BioNTech COVID-19 vaccine was the first to be granted emergency use authorization by the Food and Drug Administration on Dec. 11, 2020. The EUA was based on the interim results from the phase 3 randomized controlled trial involving 36,523 participants — about half receiving the vaccine and the other half getting a placebo — showing the vaccine “was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group,” the FDA said at the time.

Months later, on Aug. 23, 2021, the vaccine received full FDA approval, after a review of the manufacturing process, ongoing results from the clinical trial and safety monitoring. At that point, the FDA reviewed updated trial results on about 20,000 vaccine and 20,000 placebo recipients showing the vaccine was 91% effective in preventing symptomatic COVID-19. 

Yet, various social media posts in May have claimed that “just released” Pfizer documents show the vaccine is “12% effective.” That appears to be a misunderstanding of the Pfizer FDA briefing document released in December 2020, before the EUA was granted.

Hundreds of thousands of pages of Pfizer documents on its vaccine trial have been released as part of a Freedom of Information Act request, but two experts who have looked into the 12% claim — a biostatistician and an epidemiologist — have said those FOIA documents don’t appear to be the source of the claim.

Some background on the FOIA release: A group called Public Health and Medical Professionals for Transparency asked the FDA for the more than 300,000 pages of documents related to the Pfizer vaccine four days after the agency gave the shot its full approval. The FDA argued that releasing 500 pages a month was the standard rate and that staffers would need to go through all of the documents to redact some information before releasing them. In early January, a judge in North Texas set a deadline of Jan. 31 for the first batch to be released, with 55,000 pages every month to follow. At that pace, all of the documents will be public by the end of the summer. 

The documents have been subject to other false claims, as we’ve written before. But with the efficacy claim, Jeffrey S. Morris, director of the Division of Biostatistics in the Department of Biostatistics, Epidemiology and Informatics at the University of Pennsylvania Perelman School of Medicine, and Gideon Meyerowitz-Katz, an epidemiologist working on his Ph.D. at the University of Wollongong in Australia, found it likely came from a misreading of documents that were made public more than a year ago, the December 2020 Pfizer/BioNTech FDA briefing document for the Vaccines and Related Biological Products Advisory Committee meeting.

The committee, which reviews data on safety and efficacy of vaccines and then makes a recommendation to the FDA, met on Dec. 10, 2020, to discuss the emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine. The briefing document and other materials were posted online before that meeting. The committee recommended that the FDA grant that authorization, which the FDA did the next day.   

FDA Briefing Document

On May 5, Morris wrote on his website that the claim about 12% efficacy likely came from an April 3 post on Substack, as best he could determine. That post claimed to find “[d]amning results buried” in the FDA briefing document. But the author’s claim of a possible vaccine efficacy this low is “an erroneous one,” Morris wrote.

Meyerowitz-Katz also examined the claim, finding that “it is completely and utterly false” and “based on a very simple misreading of the documents.”

The author of the Substack post dismisses the vaccine efficacy of 95% in the FDA briefing document — which, as we said above, was based on 162 confirmed cases in the placebo group and eight in the vaccine group — and instead points to data on “suspected but unconfirmed” COVID-19 cases. Those totaled 1,594 in the vaccine group and 1,816 in the placebo, which would work out to a 12% efficacy figure. Except these were individuals who had at least one of a number of symptoms and subsequently tested negative on a SARS-CoV-2 PCR test.

The FDA briefing document mentions these “suspected cases of symptomatic COVID-19 that were not PCR-confirmed” and refers to “the protocol,” which is another Pfizer document that describes in detail the clinical protocol for the trial. It’s also available online.

Morris explained that the phrase “suspected but unconfirmed” isn’t in the protocol, but “the implication is clear.”

“Suspected” is used in the protocol in explaining when an unplanned PCR test should be given to a trial participant due to reported symptoms. “As described in Section 8.13, page 93/146, of the protocol,” Morris wrote, “they did this by instructing subjects to immediately contact the site to set up an unplanned potential COVID-illness visit, ideally within 3 days, if they experienced any of the following symptoms anew that COULD indicate potential COVID-19: fever, cough, shortness of breath, chills, muscle pain, sore throat, loss of taste/smell, diarrhea, and vomiting. Anyone reporting one of these symptoms is a ‘suspected’ COVID-19 case who is to report for an unplanned clinical visit to determine whether it meets the COVID-19 case definition or not,” and that visit would include a PCR test.

“If the test is positive, they are a ‘confirmed’ COVID-19 case, and by context it is clear that the others are ‘suspected but unconfirmed,'” Morris said, noting that those symptoms “of course could come from many causes not just COVID-19 infections.”

Meyerowitz-Katz wrote of the “suspected but unconfirmed” phrase: “What this actually means is that these people did not have a Covid-19 infection.”

To assume they did would be to assume an incredibly high false-negative rate for the PCR tests of more than 95%, Morris said, but the data show these tests are highly accurate. The PCR test used in the trial showed a 4% false-negative rate in this FDA document, Morris pointed out.

We asked Pfizer about these claims, and the press office told us of the released documents: “All information is reviewed meticulously by experienced medical and clinical experts who are equipped in interpreting the data in the context of the full package submitted. Non-experts reviewing such scientific data is likely to lead to information being misinterpreted or taken out of context. Regulatory authorities around the world have authorized the Pfizer-BioNTech COVID-19 vaccine and expert medical committees have and continue to review the data and recommended it.”

More than 126 million people in the U.S. have been fully vaccinated with the Pfizer/BioNTech vaccine, and it has continued to show strong effectiveness in real-world conditions, as found by various studies from around the world. For instance, a study published in the New England Journal of Medicine in July 2021 found the vaccine was 88% effective in preventing symptomatic disease in the U.K. against the delta variant.

And it still has performed well in preventing severe disease during the omicron wave, even as effectiveness against symptomatic illness waned. A Centers for Disease Control and Prevention study found that adults who had received two doses of either the Pfizer/BioNTech or Moderna vaccine had a 79% lower risk of dying or needing a ventilator if hospitalized with COVID-19, compared with unvaccinated adults, during the omicron wave. The risk was 94% lower for those who also had received a booster vaccine dose. 

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.


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