We just got our best look yet at the side effects from Pfizer's coronavirus vaccine. Here's what you should expect if you get the shot.

Andrew Dunn
pfizer vaccine
Vincent Kalut / Photonews via Getty Images

  • Pfizer's coronavirus vaccine showed no safety concerns that could threaten an emergency authorization, regulators at the US Food and Drug Administration wrote in documents released Tuesday. 

  • The detailed data shows Pfizer's shot as a highly effective and safe vaccine based on a clinical trial of more than 40,000 participants. 

  • There were temporary side effects that are generally expected with most vaccines. The most common side effects were pain at injection site (84%), fatigue (63%), and headache (55%).

  • An expert panel convened by the FDA is set to meet Thursday to discuss Pfizer's application for an emergency OK. An agency decision could come shortly thereafter in a matter of days. 

  • For more stories like this, sign up here for Business Insider's daily healthcare newsletter.

US vaccine regulators released Tuesday the most detailed look yet at a leading coronavirus vaccine candidate, outlining the safety and side effects seen in a massive clinical trial. 

Overall, the findings are positive, with the study suggesting no major safety concerns for Pfizer's vaccine. Most immunized volunteers had temporary side effects shortly after being vaccinated. Those side effects included fatigue, headache, and pain at injection site.

The US Food and Drug Administration is in the process of reviewing the COVID-19 shot for emergency use authorization, with a decision expected in a matter of days. An expert panel is set to meet Thursday to review Pfizer's application and recommend a decision to FDA regulators. 

Pfizer and its German biotech partner BioNTech tested their vaccine in a global study that randomized more than 40,000 volunteers to either get two doses of its vaccine or two doses of a placebo injection.

While Pfizer said it had enough data to show its vaccine was a success at preventing COVID-19 - being about 95% effective - the company had to wait until November 20 to submit its application to accrue enough safety information. The FDA asked for at least two months of follow-up data on more than half the volunteers who have received their second dose.

Read more: How the pharma giant Pfizer teamed up with a little-known biotech to develop an effective coronavirus vaccine in record time

The most common side effects included fatigue and headache

The results showed that younger people - those under 55 years old - recorded more side effects. These side effects were expected with a vaccine, typically appearing within a couple days of receiving a dose and lasting for only a day or two on average.

In its own summary of the data, FDA scientists said there were "no specific safety concerns identified that would preclude issuance of an EUA." 

Here were the most common side effects after getting Pfizer's vaccine: 

  • Pain at the injection site (84%) 

  • Fatigue (63%) 

  • Headache (55%)

  • Muscle pain (38%)

  • Chills (32%)

  • Joint pain (24%)

  • Fever (14%)

Pfizer and the FDA also provided information on the severe side effects that volunteers experienced. In general, those are side effects that are so bad that they stop people from performing normal activities. Most of the severe side effects from the vaccine occurred after participants got the second dose, and side effects were more common among younger participants.

In particular, among people ages 18-55, 4.6% of volunteers reported severe fatigue after getting their second injection and 3.2% had severe headaches.

Fevers were also common in that age group. About 15.8% of volunteers had a fever of at least 100.4 degrees Fahrenheit after their second shot.

Among volunteers older than 55, 2.8% reported severe fatigue and 0.5% experienced severe headaches after the second dose. 10.9% had a fever.

Scientists at the FDA and at Pfizer and BioNTech have been poring over the data, particularly to see if there were any unexpected safety concerns. Encouragingly, they didn't find anything that caused concern, according to the briefing documents released Tuesday. 

FDA regulators noted a "numerical imbalance" in cases of Bell's palsy, a condition that temporarily weakens face muscles. There were four cases of Bell's palsy among the 20,000-plus people who got Pfizer's vaccine, compared to no cases in the placebo group. 

But the FDA notes this frequency of Bell's palsy cases among those getting Pfizer's shot was not any higher than what would be expected for the general population. 

Agency scientists also said that the vaccine's safety profile was "generally similar" across different ages, genders, ethnicities, racial groups, the presence of health conditions, and people with or without evidence of previous coronavirus infections at enrollment.  The only exception was that younger people tended to have more frequent side effects.

Read more: Moderna's ambitions of pumping out up to 1 billion doses of a coronavirus vaccine rest on a former Polaroid factory that's never produced an approved drug

Read the original article on Business Insider

Latest Stories

  • A suspected Chinese spy slept with at least 2 mayors and got close to Democratic Rep. Eric Swalwell in a yearslong intelligence campaign, report says

    According to Axios, Fang Fang (aka Christine Fang) went to China in mid-2015 amid an FBI investigation into her, and has not returned since.

  • German prosecutors 'have evidence' suspect killed Madeleine McCann

    There is compelling evidence the German prime suspect in the disappearance of Madeleine McCann killed her but it cannot be shared with the public, German prosecutors said on Tuesday. “If you knew the evidence we had you would come to the same conclusion as I do,” Hans Christian Wolters, the prosecutor in charge of the case told the BBC. “But I can't give you details because we don't want the accused to know what we have on him — these are tactical considerations.” Christian Brückner, a 43-year-old convicted paedophile and rapist, was named as a suspect in the toddler’s disappearance in June. But German prosecutors have yet to charge him in connection with the case and say that while they have evidence it is not yet enough to secure a conviction. “I can't promise, I can't guarantee that we have enough to bring a charge but I'm very confident because what we have so far doesn't allow any other conclusion at all,” Mr Wolters told the BBC.

  • Despite Biden pledge, coronavirus bill in Congress now may be all Americans get: analysts

    President-elect Joe Biden has called the $908 billion coronavirus aid bill taking shape in Congress a "downpayment" toward a bigger stimulus next year, but if it passes, that is all U.S. businesses and workers should count on, economists and political analysts say. There is likely to be little appetite among Republicans for supporting a second round of $1 trillion-plus spending after Biden takes office on Jan. 20 - a task that would be made more difficult if Republicans retain control of the Senate in Jan. 5 runoff elections in Georgia - said John Lieber, managing director of the Eurasia Group political risk consultancy. "If they do the full bipartisan $900 billion, then I think it's a big ask to do anything new after Biden takes office," said Lieber, a former adviser to Senate Majority Leader Mitch McConnell.

  • Pfizer and Moderna reportedly reject invitations to Trump's vaccine 'PR stunt'

    It seems the executives leading COVID-19 vaccine development know better than to attend a big gathering right about now.On Tuesday, the White House will be hosting a "vaccine summit" apparently meant to bring vaccine developers, scientists, and government leaders together ahead of distribution of the coronavirus vaccine. But drug industry leaders have decided the event is more of a "public relations stunt," and some big names aren't even planning to attend, Stat News reports.Pfizer and Moderna are currently at the top of the COVID-19 vaccine world, having produced vaccine candidates that are more than 90 percent effective at stopping transmission of the disease. But despite the fact that both of the companies' CEOs had been invited to the vaccine summit, neither plans to attend, two sources tell Stat. The summit comes just days before the Food and Drug Administration is set to examine Pfizer's vaccine data, and a week before it will look at Moderna's. Both reviews will likely result in emergency use authorizations for the two vaccines.Many other companies involved in the vaccine distribution process — FedEx, UPS, Walgreens, and CVS among them — are expected to send representatives to the event. But they "are likely to send lower-ranking executives as opposed to their CEOs," sources familiar with the event's planning tell Stat. And despite an apparent conflict of interest, Peter Marks, the FDA official who heads vaccine approvals, may end up attending the summit, Stat reports.More stories from theweek.com Fox's Lou Dobbs berates Stephen Miller for the White House not jumping on Ted Cruz's Supreme Court offer The post-Mitch McConnell GOP is going to be a carnival of madness Christopher Nolan blasts Warner Bros. over HBO Max deal: 'The worst streaming service'

  • Mohammed bin Salman rejected claims he sent an elite hit squad to kill a Saudi spy chief exiled in Canada, arguing he's immune from prosecution anyway

    Saad al-Jabri sued Crown Prince Mohammed in Washington, DC, in August, claiming he was targeted because he knew damning secrets about the royal court.

  • Hundreds pay respects at funeral of Chechen refugee who beheaded French teacher

    Several hundred people paid their respects last week at a funeral in Russia for the Chechnyan teenager who beheaded a teacher in France over cartoons mocking the Prophet Muhammad. Samuel Paty, a 47-year old history teacher, became the target of a hostile online campaign after discussing the cartoons in a class on freedom of speech and was eventually attacked and murdered by Abdoulakh Anzorov, an 18-year-old Chechen refugee, in October. Anzorov was shot dead by police shortly after the attack on October 16. His body was repatriated to Russia last week to allow his family to bury him in his ancestral village in the predominantly Muslim region of Chechnya. Several hundred people attended the funeral on Friday in the village of Shalazhi, chanting prayers on their way to the cemetery, a video released by several media outlets showed. Salman Magamadov, the village chief, insisted in an interview with the Podyem media outlet on Monday that Anzorov received an ordinary burial without “any special honours”. Prominent Muslim clerics in Russia have used the attack to condemn French authorities for mocking their religion. Ramzan Kadyrov, the strongman leader of Chechnya, said French President Emmanuel Macron was to blame for allegedly encouraging insults against Muslims. Mr Kadyrov later sought to distance his region from the attack, insisting that the teenager, an ethnic Chechen, was born in Moscow and moved to France when he was a small child.

  • Explainer: Why 'safe harbor' day spells trouble for Trump's legal bid to overturn election defeat

    Here is an explanation of why Trump, who has made unsubstantiated claims of widespread voter fraud, is running out of time to contest Democratic President-elect Joe Biden's victory in the Nov. 3 election. "Safe harbor" day is a deadline, set by a U.S. law from 1887, for states to certify the results of the presidential election. The safe harbor date falls six days before the meeting of the Electoral College, in which slates of "electors" formally select the presidential nominee who won the popular vote in their home states.

  • Grandma gets first Pfizer vaccine shot outside of trial as Britain begins vaccinations

    Margaret Keenan, a 90-year-old grandmother from Northern Ireland, became the first person in the world on Tuesday to receive the Pfizer COVID-19 vaccine shot outside of a trial as Britain began vaccinating its population.

  • The Taliban are megarich – here's where they get the money they use to wage war in Afghanistan

    The Taliban militants of Afghanistan have grown richer and more powerful since their fundamentalist Islamic regime was toppled by U.S. forces in 2001. In the fiscal year that ended in March 2020, the Taliban reportedly brought in US$1.6 billion, according to Mullah Yaqoob, son of the late Taliban spiritual leader Mullah Mohammad Omar, who revealed the Taliban’s income sources in a confidential report commissioned by NATO and later obtained by Radio Free Europe/Radio Liberty.In comparison, the Afghan government brought in $5.55 billion during the same period. The government is now in peace talks with the Taliban, seeking to end their 19-year insurgency.I study the Taliban’s finances as an economic policy analyst at the Center for Afghanistan Studies. Here’s where their money comes from. 1\. Drugs – $416 millionAfghanistan accounted for approximately 84% of global opium production over the past five years, according to the United Nation’s World Drug Report 2020. Much of those illicit drug profits go to the Taliban, which manage opium in areas under their control. The group imposes a 10% tax on every link in the drug production chain, according to a 2008 report from the Afghanistan Research and Evaluation Unit, an independent research organization in Kabul. That includes the Afghan farmers who cultivate poppy, the main ingredient in opium, the labs that convert it into a drug and the traders who move the final product out of country. 2\. Mining – $400 million to $464 millionMining iron ore, marble, copper, gold, zinc and other metals and rare-earth minerals in mountainous Afghanistan is an increasingly lucrative business for the Taliban. Both small-scale mineral-extraction operations and big Afghan mining companies pay Taliban militants to allow them to keep their businesses running. Those who don’t pay have faced death threats.According to the Taliban’s Stones and Mines Commission, or Da Dabaro Comisyoon, the group earns $400 million a year from mining. NATO estimates that figure higher, at $464 million – up from just $35 million in 2016. 3\. Extortion and taxes – $160 millionLike a government, the Taliban tax people and industries in the growing swath of Afghanistan under their control. They even issue official receipts of tax payment.“Taxed” industries include mining operations, media, telecommunications and development projects funded by international aid. Drivers are also charged for using highways in Taliban-controlled regions, and shopkeepers pay the Taliban for the right to do business. The group also imposes a traditional Islamic form of taxation called “ushr” – which is a 10% tax on a farmer’s harvest – and “zakat,” a 2.5% wealth tax. According to Mullah Yaqoob, tax revenues – which may also be considered extortion – bring in around $160 million annually. Since some of those taxed are poppy growers, there could be some financial overlap between tax revenue and drug revenue. 4\. Charitable donations – $240 millionThe Taliban receive covert financial contributions from private donors and international institutions across the globe. Many Taliban donations are from charities and private trusts located in Persian Gulf countries, a region historically sympathetic to the group’s religious insurgency. Those donations add up to about $150 million to $200 million each year, according to the Afghanistan Center for Research and Policy Studies. These charities are on the U.S. Treasurey Department’s list of groups that finance terrorism. Private citizens from Saudi Arabia, Pakistan, Iran and some Persian Gulf nations also help finance the Taliban, contributing another $60 million annually to the Taliban-affiliated Haqqani Network, according to American counterterrorism agencies. 5\. Exports – $240 millionIn part to launder illicit money, the Taliban import and export various everyday consumer goods, according to the United Nations Security Council. Known business affiliates include the multinational Noorzai Brothers Limited, which imports auto parts and sells reassembled vehicles and spare automobile parts.The Taliban’s net income from exports is thought to be around $240 million a year. This figure includes the export of poppy and looted minerals, so there may be financial overlap with drug revenue and mining revenue. 6\. Real estate – $80 millionThe Taliban own real estate in Afghanistan, Pakistan and potentially other countries, according to Mullah Yaqoob and the Pakistani TV Channel SAMAA. Yaqoob told NATO annual real estate revenue is around $80 million. 7\. Specific countriesAccording to BBC reporting, a classified CIA report estimated in 2008 that the Taliban had received $106 million from foreign sources, in particular from the Gulf states.Today, the governments of Russia, Iran, Pakistan and Saudi Arabia are all believed to bankroll the Taliban, according to numerous U.S. and international sources. Experts say these funds could amount to as much as $500 million a year, but it is difficult to put an exact figure on this income stream. Building a peacetime budgetFor nearly 20 years, the Taliban’s great wealth has financed mayhem, destruction and death in Afghanistan. To battle its insurgency, the Afghan government also spends heavily on war, often at the expense of basic public services and economic development.[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]A peace agreement in Afghanistan would allow the government to redirect its scarce resources. The government might also see substantial new revenue flow in from legal sectors now dominated by the Taliban, such as mining. Stability is additionally expected to attract foreign investment in the country, helping the government end its dependence on donors like the United States and the European Union.There are many reasons to root for peace in war-scarred Afghanistan. Its financial health is one of them.This article is republished from The Conversation, a nonprofit news site dedicated to sharing ideas from academic experts. It was written by: Hanif Sufizada, University of Nebraska Omaha.Read more: * How a troop drawdown in Afghanistan signals American weakness and could send Afghan allies into the Taliban’s arms * After US and Taliban sign accord, Afghanistan must prepare for peaceHanif Sufizada does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

  • San Francisco officer who seriously injured suspect indicted

    Accused burglar, whose leg was amputated after arrest, also charged; DA declines to give details before arraignment.

  • A Kansas radiology technician slept in an RV outside his hospital for over a week after coworkers got sick with COVID-19 and no one else was available to take X-rays

    "To keep a critical access hospital open, you have to have X-ray and lab functioning," Eric Lewallen told the AP.

  • Emirati royal buys 50 per cent stake in Israeli football club

    A member of the Emirati royal family has bought a 50 per cent stake in an Israeli premier league club, the latest major deal to emerge from a normalisation treaty struck by the Jewish state and the United Arab Emirates earlier this year. Sheikh Hamad Bin Khalifa Al Nahyan signed the deal with Beitar Jerusalem, a controversial club which has never signed an Arab player and has battled with a reputation for anti-Muslim racism. "I am thrilled to be a partner in such a glorious club that I have heard so much of and in such a great city, the capital of Israel and one of the holiest cities in the world,” Sheikh Hamad said in a statement on the club's website. The reference to Jerusalem as the "capital" of Israel is noteworthy as the city is claimed by both the Israelis and the Palestinians as their own, and is one of the biggest sources of tension in the Israeli-Palestinian conflict. A spokesman for the club said that Beitar would set up a new board of directors and that Sheikh Hamad’s son would represent him on it. Sheikh Hamad has also pledged to invest 300m shekels (£69m) in the club over the next ten years. The purchase is the latest in a string of lucrative deals made possible by the Abraham Accords, an agreement to end hostilities between Israel, the UAE and Bahrain.

  • Tuesday's 'safe harbor' deadline essentially ends Trump's doomed election challenges

    President Trump's janky legal and political campaign to overturn his loss to President-elect Joe Biden through the courts and state legislatures effectively dies Tuesday, when the "safe harbor" deadline presumptively locks in certified vote counts. As of Monday night, 47 states and the District of Columbia have certified their results, giving Biden electoral votes to spare, according to Reuters' tally. When the Electoral College formally casts ballots on Dec. 14, Biden should have 306 electoral votes to Trump's 232.Under the 1887 Electoral Count Act, each state's slate of electors chosen by the "safe harbor" date " is final and presumptively cannot be challenged in court or in Congress," CNN's Elie Honig explains. "The states are not required to finalize their electoral votes by the safe harbor date — but if they do, those determinations are protected by federal law," so this "should effectively extinguish any dying embers of hope even for the last few remaining election denialists.""Trump's legal team publicly says the safe harbor deadline is meaningless and they'll simply disregard it," since it isn't enshrined in the Constitution, Politico reports. "But the campaign's legal filings tell another story," and "as Trump attempts to bludgeon his way to a second term, judges and lawyers for both sides have also treated the safe-harbor deadline as a cause for urgency." There will still be a bit of drama as Trump allies in Congress challenge the final results Jan. 6, and Trump may have other reasons for publicly keeping up his losing fight.> Per its FEC report yesterday, Trump's efforts to overturn the results of the election have cost his campaign about $8.8 million so far, including about $2.3 million on lawyers. > > But they've helped him raise $207 million. https://t.co/lYZ63XODg8 https://t.co/3eR3uB1WYJ> > — Brad Heath (@bradheath) December 4, 2020But "Trump's allies have increasingly acknowledged their losing legal hand," Politico reports, and the accumulating losses "have all underscored a reality that seems to be sinking in inside Trump's orbit: It's over."More stories from theweek.com Fox's Lou Dobbs berates Stephen Miller for the White House not jumping on Ted Cruz's Supreme Court offer The post-Mitch McConnell GOP is going to be a carnival of madness Christopher Nolan blasts Warner Bros. over HBO Max deal: 'The worst streaming service'

  • 10 Indoor Plant Stands That Seriously Stand Out

    Take your home garden to the next level this winterOriginally Appeared on Architectural Digest

  • China says firmly opposes U.S. interference in its domestic affairs

    China said on Monday it firmly opposes and strongly condemns U.S. interference in its domestic affairs if a media report that Washington is preparing new sanctions on Chinese officials over a Hong Kong crackdown is true. If the United States insists on going down the wrong path, China will continue to take firm counter measures to safeguard its sovereignty and security, Hua Chunying, a spokeswoman with the foreign ministry told a briefing. The United States is preparing to impose sanctions on at least a dozen Chinese officials over their alleged role in Beijing's disqualification of elected opposition legislators in Hong Kong, Reuters reported on Monday citing sources.

  • Former Alabama state senator dies of Covid, warns in his last words, 'We messed up'

    "We let our guards down. Please tell everybody to be careful. This is real, and if you get diagnosed, get help immediately," former Sen. Larry Dixon said.

  • Iran says US 'got the message' on tense exchanges in Gulf

    Iran said Monday it was glad the United States “got the message” and modified its behavior in the Persian Gulf, after the top U.S. Navy official in the region said his forces had reached a state of deterrence with Iran after months of regional attacks and seizures at sea. “Unfortunately, the U.S. has often had an unprofessional approach toward Iran’s navy,” he said. Paparo, who oversees the Navy's 5th Fleet based in Bahrain, said the two sides had reached a state of “uneasy deterrence” and that he had a “healthy respect” for Iran's regular navy and the naval forces of its Revolutionary Guard.

  • Schumer: Biden ‘Considering’ Forgiving $50,000 in Student Loan Debt via Executive Action

    President-elect Joe Biden is “considering” forgiving $50,000 in federal student loan debt for low-income and middle class students, Senate Minority Leader Chuck Schumer (D., N.Y.) said Monday.Schumer held a press conference alongside Democratic Congressmen-elect Ritchie Torres, Mondaire Jones and Jamaal Bowman of New York, during which the group announced they have “come to the conclusion” that Biden can “forgive $50,000 of debt the first day he becomes president.”“You don’t need Congress, all you need is the flick of a pen and President-elect Biden — then President Biden — can make this happen,” Schumer said.> JUST IN: Sen. Chuck Schumer: President-elect Joe Biden is "considering" forgiving $50,000 in federal student loan debt for all borrowers. pic.twitter.com/KS4WNgAb79> > -- The Hill (@thehill) December 7, 2020He added that the group is urging Biden to choose a secretary of education who will support student loan forgiveness because “it’s up to the secretary of education officially, but if President Biden wants it, I’m sure it will happen.”“This debt is a huge burden on the backs of our students standing in the way of them and their economy and it stays with them for a very long time,” he said.He said they are calling on Biden to take executive action to administratively cancel up to $50,000 in student loan debt for federal student loan borrowers with an income below $125,000, and to do so in a way that the borrowers would have no tax liability when they receive the forgiveness.Schumer said he has spoken to Biden about "how important" the loan forgiveness is and that he is "considering" it.Asked if Biden will have the executive authority to forgive the debt, the New York Senator said the president-elect is researching that and "I believe when he does his research, he will find that he does."When asked what the forgiveness would mean for families who have “made sacrifices to pay off student loans” Schumer said it would be “good for everybody.”“Lots of students paid off student loans but it’s such a burden it’s good for everybody to make sure that this debt is vanquished,” he said. “It’s never been this high.”He added that when he finished college it cost $1,700 but “people can’t afford it now.”

  • The Trump administration reportedly rejected an offer from Pfizer for more COVID-19 vaccine doses, and now other countries might get them

    The Trump administration purchased 100 million doses of Pfizer and BioNTech's two-dose vaccine, enough to vaccinate 50 million Americans.

  • Rep. Trent Kelly Becomes Highest-Ranking Military Member in Congress

    An engineer and combat veteran, Kelly served in the 1991 Persian Gulf War and deployed to Iraq in 2005 as operations officer.