Pfizer

Pfizer Inc. is a pharmaceutical company that created many well-known drugs. Pfizer brands include Advil, Bextra, Celebrex, Diflucan, Lyrica, Robitussin and Viagra.

The Big Pharma company is also the mastermind behind many popular consumer products. Some of the company’s biggest names include Chapstick and Preparation-H.

Pfizer got its start more than 150 years ago. It’s come a long way, evolving from a “one-stop-shop” to a multinational corporation.

Pfizer has had many triumphs. It discovered citric acid. It mass produces penicillin and vitamin C.

Over the years, the company has also faced lawsuits where consumers claimed the drugmaker sold defective drugs, and the U.S. government has charged the company with health care fraud.

In December 2020, the company became the first to receive an emergency use authorization from the FDA for a COVID-19 vaccine. In response to the spread of the COVID-19 Delta variant, the Centers for Disease Control and Prevention and other health officials announced that a booster shot will be available starting the week of Sept. 20, 2021 for Americans who are fully vaccinated with the Pfizer vaccine.

On Aug. 23, 2021, the FDA approved the Pfizer-BioNTech vaccine, which will now be marketed as Comirnaty.

Pfizer is a publicly-traded global pharmaceutical company headquartered in New York City. Its revenues reached $51.8 billion in 2019.

Pfizer makes Eliquis, Enbrel, EpiPen, Depo-Provera, Dimetapp, Neosporin, Xeljanz and Zithromax/Zmax. It specializes in vaccines and cancer, heart and diabetes treatments. It also makes medicines for disorders of the endocrine (hormones) and nervous systems.

The shareholder-owned company operates in 180 countries. Its research headquarters are in Groton, Connecticut. It employs more than 96,000 people worldwide.

In response to the coronavirus pandemic, Pfizer partnered with BioNTech in April 2020 to begin developing a COVID-19 vaccine. The vaccine candidate BNT162b2 is an mRNA vaccine.

In November 2020, the drugmaker announced that data from Phase 3 clinical trials had shown the vaccine was safe and effective with an efficacy of 95 percent. It requires two doses, 21 days apart.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer chairman and CEO, said in a press release. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

A few days after the announcement of positive clinical trial results, Pfizer and BioNTech submitted a request for an emergency use authorization from the FDA. On Dec. 11, 2020, the FDA issued the authorization, which allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S.

“The FDA’s decision to grant the [authorization] indicates that the vaccine meets safety and effectiveness requirements,” Dr. Rupali J. Limaye, a professor and scientist at the Johns Hopkins Bloomberg School of Public Health told Drugwatch.

Pfizer intends to gather data in a U.S. COVID-19 Pilot Program from four states: Rhode Island, Texas, New Mexico and Tennessee. It will use the data to refine its delivery and deployment of the vaccine, and the states will not receive vaccines early because of the program.

Pfizer and BioNTech said they would produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. The two companies will use facilities in the U.S., Belgium and Germany to manufacture the vaccine and meet global need.

“Pfizer’s COVID-19 vaccine development and manufacturing costs have been entirely self-funded, with billions of dollars already invested at risk. The company will continue bearing all the costs of development and manufacturing in an effort to help find a solution to this pandemic as fast as possible,” the company said in a Nov. 16, 2020 press release.

The CDC, FDA and other medical authorities released a joint statement on Aug. 18, 2021 announcing that a third booster shot for Americans who received the Pfizer vaccine will be available beginning the week of Sept. 20, 2021.

“We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster,” the statement said.

Officials say the Pfizer vaccine is highly effective, but like most most vaccines, it gets less effective over time. A booster shot will help ensure they continue to be protected against the risk of severe disease, hospitalization and death, according to the official statement.

The FDA approved the vaccine, now called Comirnaty, to prevent COVID-19 disease in individuals 16 years of age or older on Aug. 23, 2021. The EUA for children 12 through 15 is still in place. The EUA also allows certain immunocompromised individuals to get a third dose.

German-American cousins Charles Pfizer and Charles Erhart began Pfizer in 1849. Brooklyn was Pfizer’s first home.

The company started as a manufacturer of fine chemicals. It operated out of one building. The stand-alone structure served as an office, laboratory, factory and warehouse.

As the company expanded, the headquarters moved to Manhattan in 1868. A separate warehouse opened in Chicago in 1882.

One of the company’s first successful products was Santonin, a cure for intestinal worms.

Pfizer became known as the world’s top producer of vitamin C. People have used the vitamin as a defense against scurvy and the common cold.

In 1952, Pfizer moved into eight new international locations. It also established its Agricultural Division, later known as Animal Health.

Pfizer acquired several other companies over the years. Many of these companies made billions for Pfizer with their established research and drug development.

Warner-Lambert was one of these companies. It’s the original maker of Lipitor. Warner-Lambert merged with Pfizer in 2000.

Lipitor quickly grew to be the largest-selling pharmaceutical of any kind in history. It reached $9.6 billion in revenue in 2011.

Pfizer is the manufacturer and/or marketer of many well-known products. The list below includes some of the company’s most recognizable brands. It is not an exhaustive list.

Pfizer has had to recall some of its popular products due to quality issues and poor packaging. Effexor XR and Prempro are two products affected by recalls. More recently, the company recalled two lots each of Relpax in 2019 and Duavive in 2020, and all lots of Chantix 0.5 and 1 mg tablets in 2021.

Effexor XR

In 2014, Pfizer recalled two lots of its antidepressant drug Effexor XR. Tikosyn was discovered in an Effexor XR bottle. Tikosyn is one of the company’s heart pills. Pfizer warned that the combination of the two different drugs could be deadly.

Prempro

In 2013, Pfizer announced it was recalling five lots of Prempro. Prempro is a hormone replacement therapy drug. Routine testing revealed the strength of the drug was low.

Chantix 0.5 mg and 1 mg

On Sept. 16, 2021, Pfizer voluntarily recalled all lots of the Chantix 0.5 mg and 1 mg tablets due to an increased cancer risk from high levels of an ingredient called N-nitroso-varenicline, also known as a nitrosamine. The company stated the recall is “precautionary” as no cancer-related issues have been detected in the testing of Chantix, or with people taking the smoking cessation drug.

Over the years, Pfizer has faced lawsuits involving some of its most popular drugs. Courts have dismissed thousands of lawsuits against Pfizer. The company has also agreed to settle cases involving claims of illegal marketing and health care fraud.

Protonix

People are suing Pfizer over Protonix. Protonix lawsuits say Pfizer failed to warn about the risk of kidney problems. In 2013, Pfizer agreed to pay $55 million to settle criminal charges. The U.S. Department of Justice said Wyeth promoted Protonix for unapproved uses in 2000 and 2001. Pfizer acquired Wyeth in 2009.

Learn More About Protonix Lawsuits

Prempro

Nearly 10,000 women filed Prempro breast cancer lawsuits against Pfizer. By 2012, Pfizer settled most of the claims for more than $1 billion.

Chantix

About 3,000 people filed Chantix lawsuits against Pfizer. They claimed Chantix caused suicidal thoughts and severe psychological disorders. In 2013, the company set aside about $288 million to resolve these cases. One case settled for an undisclosed amount just before trial in 2012.

Depo-Testosterone

More than 7,800 testosterone therapy lawsuits had been filed against manufacturers as of November 2020. Pfizer had reached an agreement with the consumers suing the company in February 2018, ending its role in the massive litigation. The lawsuits say testosterone products caused strokes, blood clots and heart attacks.

Learn More About Testosterone Lawsuits

Effexor

A federal panel closed the consolidated Effexor litigation in 2013. Lawsuits claimed birth defects.

Zoloft

A judge dismissed Zoloft cases in 2016. Lawsuits included similar claims to Effexor XR. The judge did not disagree that Zoloft caused birth defects. But the judge concluded there was insufficient evidence to definitively link the two.

Eliquis

A judge dismissed a group of federal Eliquis cases in 2017. Injured patients continue to file severe bleeding claims in Delaware state court.

Lipitor

A judge dismissed Lipitor lawsuits in 2017. Women who took the drug filed lawsuits after developing Type 2 diabetes. There is currently an appeal pending.

Trovan

In 1996, Pfizer conducted an unapproved clinical trial. It involved children with meningitis in Nigeria, CBS News reported. The trials led to the deaths of 11 children. Dozens more were left disabled.

Trovan is a drug severely restricted in use because of its potential to cause liver damage. Injury to the liver as a result of taking Trovan can lead to liver failure and death.

In 2011, Pfizer paid $700,000 to four families who lost children during the Trovan trials.

In addition, the company set up a $35 million fund for those affected by Trovan. Pfizer also agreed to sponsor health projects in Kano, Nigeria.