CDC investigates Virginia woman, 45, who died after getting the Johnson & Johnson vaccine last month as US pauses its use over blood clot fears
- A woman in Virginia died on March 18 after being given J&J's vaccine March 6
- The news was announced on Tuesday, as the CDC called for a halt in their jab
- The CDC said that six people had suffered from blood clots after J&J's vaccine
- More than 6.8 million people have received J&J's vaccine in the United States
- The CDC is meeting on April 14 to review the evidence and reassess J&J Virginia is stopping using Johnson & Johnson's COVID vaccine after a 45-year-old woman died following her vaccination in March.
The Centers for Disease Control and Prevention (CDC) is investigating the woman's death, Virginian health authorities announced on Tuesday.
The CDC's Vaccine Adverse Event Reporting System (VAERS) system notes the woman who died began having headaches six days following vaccination, then was hospitalized once the headache worsened and she had started dry heaving.
A head CT scan showed hemorrhaging expanding up to 1.6 centimeters and eventually, cortical vein thrombosis, as listed in the six other cases.
She died on March 18, Richmond.com reported - 12 days after receiving a dose administered by a school.
VAERS does not list any known allergies or underlying medical conditions other than depression.
News of her death, and Virginia's decision to stop using the J&J vaccine, came on the day the CDC and the Food and Drug Administration (FDA) advised a pause in the use of the company's jabs.
Their recommendation was made after six patients, out of the 6.8 million to receive the jab so far, reported blood clots.
J&J announced that they were also delaying the rollout of their vaccine in Europe, and pausing clinical trials.
A woman in Virginia has died after receiving in March the Johnson & Johnson COVID vaccine
The Johnson & Johnson vaccine was approved in the United States on March 1
The patients were all women aged 18-48, who suffered a cerebral venous sinus thrombosis (CVST) six to 13 days after receiving the jab.
It is still too early to tell whether or not the vaccine even caused the blood clots and it is a one in a million side effect.Five times as many people have died from COVID-19 in the U.S. as they do from blood clots ever year.
The agencies, however, say they want to do more tests and studies and that it could take days for them decide on whether or not to resume it.
They may impose a restriction on the vaccine based on the demographic of people who have developed blood clots - all of them are women under 50.
These are the vaccines being used around the world to treat COVID-19. Not all of them have been approved in every country. J&J and AstraZeneca have been linked to blood clotting
President Biden said in the Oval Office on Tuesday that the U.S. had enough vaccine available
The White House on Tuesday tried to smooth over the sudden halt of the Johnson and Johnson COVID-19 vaccine, claiming it would not affect their goals to vaccinate the U.S. - despite health experts saying it clearly sets back the country's rollout.
President Joe Biden said in the Oval Office on Tuesday: 'I made sure we have 600 million doses of the mRNA - not of either Johnson & Johnson or AstraZeneca.
'So, there is enough vaccine that is basically 100 per cent unquestionable for every single solitary American,' he said.
Now, everyone who had a J&J appointment has been told they'll get one of the other doses instead - which suddenly eats into the country's stock pile of each, and sets future appointments back even further.
Pfizer said it was ramping up production by 10 per cent in light of the J&J halt.
Now, it says it will deliver 220 million doses by the end of May.
The U.S. has only fully vaccinated 28 per cent of its population.
It is behind Israel, Bahrain and Chile, all of which have considerably smaller economies and populations.
When counting just how many first vaccine doses have been given out, the UK is third in the world after Israel and Chile and the U.S. is fifth rather than fourth.
Around one million people a week (142,857 a day) are receiving the J&J vaccine.
This is how the vaccine effort in the US is ramping up. Around 20 percent of the population has now been vaccinated
It is considerably less than the number receiving Pfizer and Moderna doses (5million a week, 714,285 a day).
The announcement sent Johnson and Johnson shares plummeting by three percent and prompted health industry experts to ask what will now be done to keep the vaccine plan on course.
Experts said that the delay will inevitably set the vaccine effort back.
'This will delay our vaccination efforts,' Dr. Kavita Patel told CNBC, saying Pfizer and Moderna could not be expected to just 'pick up the slack' as the FDA and CDC says they will.
'This is a devastating blow to this J&J vaccine effort in the United States.
'Johnson and Johnson was incredibly useful for mobile vaccination. You could just do one shot.
'This is definitely going to cause a ripple effect in our attempt in the United States. In the next one to three weeks, we just can’t substitute it.'
While it has a lower efficacy rate than the other two vaccines, the J&J vaccine was considerably more efficient because it required just one dose, instead of two over 21 days.
It became available much later than Pfizer and Moderna, but 6.8million have had it since it March 1, when it was first dished out.
The US has ten million doses of it currently that have not yet been administered, and it ordered a total stockpile of 200million.
Former president Donald Trump led criticism of the announcement, which he said was hasty and unnecessary, and would send people 'up in arms'.
The FDA and CDC says people who received the vaccine more than a month ago do not need to worry.
People who received it within the last 'few weeks' should 'look for symptoms including sudden pain, shortness of breath, severe headache, abdominal pain, leg pain, or shortness of breath, should seek medical treatment.'
COVID-19 vaccine side effects: Doctors explain the reactions after receiving Pfizer, Moderna or Johnson & Johnson shots, why some people get them - and why you shouldn't worry
Millions of Americans are currently receiving coronavirus vaccinations as the U.S. works to restore some sense of normalcy from the pandemic.
According to the Centers for Disease Control and Prevention (CDC), 33 percent of the US population has received at least one dose and 19.4 percent are fully immunized, either from Pfizer-BioNTech, Moderna or Johnson & Johnson.
However, some people have been wary of being vaccinated due to fears of experiencing side effects such as fever or headache while others have heard anecdotal reports of more extreme reactions including large rashes on the arm or going into anaphylaxis.
Doctors say that severe reactions are rare, and that common side effects, such as pain at the injection site, are a sign that your immune system is building up a response.
DailyMail.com spoke to three infectious disease experts about what side effects to expect from each COVID-19, why some people get them and what it means.
PFIZER-BIONTECH
The most common symptoms of the Pfizer vaccine are pain or swelling at the injection site, headache, fatigue, fever, chills and muscle pain.
'Somewhere between 20 to 80 percent of people will experience that,' Dr Richard Kennedy, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, and co-director of the Mayo Clinic Vaccine Research Group, told DailyMail.com.
'They're mostly mild to moderate symptoms and they last about a day or two.'
Dr Thad Stappenbeck, Chair of the Lerner Research Institute at the Cleveland Clinic, in Ohio, said that, in his experience, headache is the most common side effect.
'Headache is probably the most common and, anecdotally, from people I know who have been vaccinated,' he told DailyMail.com
Then, there are rarer side effects, such as nausea, vomiting and swelling of the lymph nodes and armpits.
Kennedy says less than one in 10 people will experience these side effects.
Finally, there are the rare allergic reactions to the vaccine, which can includes hives, itching and swelling and even anaphylaxis.
Anaphylactic shock is a severe and potentially life-threatening reaction to an allergy from food, medicine or even a type of material.
The immune system releases chemicals that flood the body, blood pressure suddenly drops, and airways narrow, which prevents someone from breathing normally.
Kennedy said that about one in 100,000 people who get the vaccine will experience such a reaction.
However, the good news is that 'it's fairly rare and fairly treatable,' he said.
For this reason, the CDC requires vaccination sites to monitor everyone for 15 minutes after receiving their shot and those with a history of severe allergies for 30 minutes.
The doctors also add that people are more likely to experience stronger reactions after the second dose because the immune system has been primed to fight the virus and mounts a response after getting the final shot, only to realize it's a false alarm.
MODERNA
Similar to the Pfizer vaccine, the most common side effects of the Moderna vaccine include pain at the injection site, fever, chills, headache and tiredness.
'Low-grade fever, aches and pain, difficulty sleeping on night one, they're flu-like symptoms,' Dr Robert Murphy, an infectious diseases specialist at Northwestern Medicine, in Chicago, Illinois, told DailyMail.com.
'They're self-limited and gone within 48 hours.'
Another rare reaction, but only in Moderna patients, is 'Covid arm,' in which people experience itchy and swollen skin, sometimes accompanied by red lumps
Also like Pfizer, people are more likely to have stronger side effects after the second dose.
A very small number of Moderna patients have also reported suffering anaphylaxis following their first dose.
'This is a well-documented phenomenon,' Murphy said. 'They can have hives and swelling, but it's a very small number.'
Some recipients - but only of the Moderna shot - have reported experiencing 'Covid arm,' in which people have itchy and swollen skin, sometimes accompanied by red lumps or hives.
But the splotch is a harmless response from the immune system to the shot that fades from the arm within a week.
The official term used by dermatologists and allergists to describe the side effect is 'delayed cutaneous hypersensitivity.'
'The vaccine attracts immune system cells to the injection site, which is why you see a rash, then it dissipates and within a day or two,' said Stappenbeck.
'It's a little troubling at first, but not significant and there are no long-term effects.'
JOHNSON & JOHNSON
The Johnson & Johnson single-dose coronavirus vaccine has noticeably milder side effects than either of the vaccines from Pfizer or Moderna.
'Almost across the board fewer people are reporting side effects,' Kennedy said.
'They are more mild. The most common ones are pain at the injection site, which is not surprising since it's a needle entering your arm, which about 50 percent will experience.'
He said about one-third of recipients report fatigue and muscle pain, 10 to 15 percent report nausea, and about 10 percent report swelling and redness at the injection site.
So why does J&J's shot produce fewer side effects? Murphy said it's because this vaccine is different from the other two.
J&J's vaccine combines genetic material from the new virus with the genes of the adenovirus - which causes the common cold - to induce an immune response.
Comparatively, Pfizer's and Moderna's vaccines use a newer platform, part of the pathogen's genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.
'They're very different mechanisms and different manufacturing processes,' Murphy said.
There have not been reports of anaphylaxis among J&J recipients, but Stappenbeck said that may be because fewer people have received the shot.
'It could just be a numbers game at this point,' he said.
WHY ARE YOUNGER PEOPLE HAVING MORE SEVERE SIDE EFFECTS?
As more vaccines have been administered, there have been reports of younger people have more severe side effects compared to younger people.
The doctors say this because immune systems evolve as we age.
'As we get older, everything about or bodies doesn't work as well and the immune system is no exception,' Kennedy said.
Clinical trial data showed that young people reported more side effects after receiving vaccine doses than older people.
'The reality is that younger people have stronger immune systems and when you're older, you don't mount as big of a response,' Murphy added.
However, it does not mean older people aren't protected and that the vaccines are still just as protective in senior citizens as in young adults.
ARE WOMEN MORE LIKELY THAN MEN TO HAVE A REACTION?
Also reporting more side effects are women.
Women are more likely to report worse side effects after receiving COVID-19 vaccines then men are, CDC data reveal.
Last month, officials looked at nearly 7,000 reactions reported to the agency's Vaccine Adverse Event Reporting System.
They found that nearly 80 percent of the reactions were reported by women, making them four-time more likely to report a side effect than men.
Kennedy said that the reason behind this is a mix of biological and behavioral.
'Women's immune systems behave a little differently, they have a more robust antibody response,' he explained.
'They're also more likely to go to the doctor if something is wrong whereas men are more likely to try and tough it out.'
SHOULD I GET A VACCINE?
All three physicians say that the unequivocal answer is: yes, you should get a COVID-19 vaccine as soon as it becomes available to you.
'The efficacy of these vaccines have been remarkable,' Stappenbeck said.
'Less than one percent of fully vaccinated people are later infected. That's better than the numbers we've gotten in the trials. that's what we call real-world data.'
Stappenbeck also encourages to prepare for the possibility of having side effects, such as being able to take off work the next day just in case and having an adequate supply of water and Tylenol.
However, he suggests not taking the medication as a prophylactic.
'Wait until you have symptoms, if you have symptoms, and then then take it,' Stappenbeck said.
'The limit is four grams per day, and you don't want to overdose on Tylenol.'
The group also adds that any potential side effects you may are less worse than the possibility of getting COVID-19.
'You don't know how sick you will be until you get infected,' said Kennedy.
'You may be asymptomatic or you might be on a ventilator. Then you'll say I wish I had gotten the vaccine and, by then, it is too late
Reporting by Mary Kekatos, Senior Health Reporter for DailyMail.com
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