The Biden administration said the pause in the Johnson & Johnson vaccine rollout will not impact their vaccine goals.
Jeff Zients, the White House COVID-19 Response Coordinator, downplayed the pause in the vaccine distribution, saying it was being done ‘out of an abundance of caution.’
He also argued the Johnson & Johnson does not make up enough of the U.S. supply to affect the administration’s goals of getting a shot in the arm of 200 million Americans by President Joe Biden’s 100th day in office on April 30th and to have enough shots for every adult American by the end of May.
‘This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,’ he said in a statement released by the White House.
He noted the U.S. has enough supply of the Pfizer and Moderna vaccines to meet their goal. Those vaccines require two shots unlike Johnson & Johnson’s single dose.
‘The United States has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office – and continue on to reach every adult who wants to be vaccinated,’ he said.
He added that the administration is working to reschedule appointments for those slated to get the Johnson & Johnson shot.
‘We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine,’ Zients said.
President Biden and first lady Jill Biden received the Pfizer vaccine while Vice President Kamala Harris and second gentleman Doug Emhoff received the Moderna version.
President Joe Biden’s administration said the pause in the Johnson & Johnson vaccine rollout will not impact their vaccine goals
Zients’ statement comes after the FDA and CDC recommended a pause in the US roll-out of the Johnson and Johnson vaccine after six women developed rare blood clots and one died after receiving the shot.
Seven million people in the US have had the one-shot vaccine.
The percentage of people who have developed blood clots from it is 0.00008. In the US, 0.27 percent of the population suffer from Deep Vein Thrombosis – a more severe form of blood clot – every year. The women who developed blood clots are all aged between 18 and 48.
According to anonymous health officials cited by The New York Times, one of them – who has not been identified – died and another, who is in Nebraska, is in a critical condition. The two authorities are not revoking emergency authorization of it, but say they are recommending a pause in the administering of it until more data is collected.
The FDA and CDC on Tuesday morning announced it was recommending a pause in the J&J vaccine over concerns over blood clots
Doctors are also urging people not to panic; the rate of blood clots in people who have had the vaccine is one in a million.
In the state of New York, people with a vaccine appointment for J&J will instead receive the first dose of Pfizer. All J&J appointments in Washington DC have been canceled between April 13 and 17. Rhode Island has halted giving out new J&J appointments. It’s unclear if people with existing appointments can still get it. Indiana is canceling all J&J appointments, as is the District of Columbia.
Nashville’s Metro Health department has announced that people with J&J appointments at a drive-thru site at K-Mart will instead receive a first-dose of the Pfizer vaccine.
A North Carolina medical group – Cape Fear Valley Health – has also cancelled all of its J&J appointments at clinics on Wednesday and Friday. Doctors have been told they can offer people with J&J appointments the Pfizer vaccine instead, but only if they have enough of it. Ohio Gov. Mark DeWine is also telling all vaccine sites to stop giving out the vaccine.
A medical professional from UofL Health administers a vaccine to a patient in their vehicle at University of Louisville Cardinal Stadium in Kentucky on Tuesday
Kent State University student Marz Anderson gets his Johnson & Johnson COVID-19 vaccination – more than 6.8 million of the J&J vaccine have been distributed
J&J said it was aware of the blood clots but that there was ‘no clear relationship’ between its vaccine and the people who had developed them.
In their joint statement, the CDC and FDA said: ‘As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
‘In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
‘Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.’
They added the events appear to be ‘extremely rare’ but ‘we take all reports of health problems very seriously’.
‘People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.’
Cities and states are slowly announcing if appointments for J&J are canceled. Some, like New York, are giving out Pfizer first doses to people who had J&J appointments
An HHS official told CBS News on Tuesday morning that the government was waiting to hear more from the FDA and CDC.
‘We’re going to let the FDA review the cases in question here over the next few days.
‘They’re going to make a determination, and we’ll go from there.
‘[FDA is] going to look at these cases & determine whether any changes need to be made to the recommendations for use…do they need to update labeling to note the adverse reaction? Who should receive it, who shouldn’t? If there are any concerns like that.’
J&J said it was aware of the roll-out pause and the blood clots but they said there is no clear link between their shot and the problems
In October, the company paused its vaccine trial after a male participant developed a blood clot.
Experts are urging caution, telling people not to ‘freak out’ but to pay attention to any unexplained pain they may be feeling.
‘The first take away is that it’s a very rare event. You’re talking about one per million. You will see events like this that you couldn’t see in the clinical trial just because you have millions of people involved.
‘It probably is related. It’s rare. But I want to congratulate the CDC and FDA for very quickly jumping on it – halting the vaccination until we know more. This is exactly the right move until we know more.
‘You’re likely going to be OK. You think about a 1 in a million event…You cross the street every day, you have a much higher chance of getting run over by a car.
‘I think, what people need to be is, don’t freak out. I would be going on with my life, but I’d be in tune with my body.
‘If I develop shortness of breath, if I develop leg pain, a headache within two to three weeks of having had the Johnson & Johnson vaccine, I would immediately notify my healthcare provider,’ Dr. Carlos del Rio, executive associate dean at Emory University School of Medicine, told CNN on Tuesday morning.
J&J shares dropped by almost 3 percent in pre-market trading after the announcement from the two federal agencies
The company’s shares decreased by 3 percent in early trading on Tuesday after the announcement from the CDC and FDA.
The vaccine was approved in the US on February 27 and it was given the greenlight by the World Health Organization in March, but it has not yet been approved by individual European countries like the UK.
In Europe, the roll-out of the AstraZeneca-Oxford vaccine has also been paused in some countries over similar concerns over blood clots.
Moderna rushed to assure people who’d had its vaccine that it was safe and did not lead to blood clots
Thirty people out of the 5million who received it developed the blood clots – a higher percentage of 0.0006.
Austria, Estonia, Latvia, Luxembourg, Lithuania, Romania, Denmark, Norway and Iceland, the Netherlands and Ireland, Germany, France, Italy, Spain, Slovenia, Cyprus, Sweden all paused the vaccine.
The European Medicines Agency however said the rewards of the vaccine far outweighed the risk.
The vaccine has not been paused in the UK.
The shot has still not yet received FDA approval but Dr. Anthony Fauci, the country’s leading infectious diseases expert, said it seems safe, and that it has not yet been rolled out in the US because there are so many other shots available.
‘I think that the AstraZeneca vaccine from a standpoint of efficacy is a good vaccine, and if the safety issue gets straightened out in the European Union… the efficacy of that vaccine is really quite good,’ he told BBC radio on Tuesday.
This is how the vaccine effort in the US is ramping up. Around 20 percent of the population has now been vaccinated
‘Whether or not we ever use AZ is unclear but it looks right now at this point in time that we will not need it.
‘It’s not a negative indictment of AZ, it is just possible that given the supply that we have from other companies that we may not need to use an AZ vaccine,’ he said.
There is no information about the woman who died after receiving the J&J vaccine who developed blood clots.
Another woman died after receiving the vaccine but from a stroke, according to her daughter.
Virginia Ellington, 63, died within days of receiving the vaccine. While there is no official link yet between her death and the vaccine, her daughter insists she was otherwise healthy.
No government body has linked any of the vaccines to any deaths yet, but relatives have anecdotally.
A Miami doctor’s wife died of a stroke after receiving the second dose of the Pfizer vaccine.
A Utah mother also died within days of receiving the second dose of the Moderna vaccine. Their families insist that it was the vaccine that killed them.
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.
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.
The most common symptoms of the Pfizer vaccine are pain or swelling at the injection site, headache, fatigue, fever, chills and muscle pain. Pictured: Bials of the Pfizer-BioNTech COVID-19 vaccine in Pfaffenhofen, southern Germany, January 15
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.
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.’
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. Pictured: Boxes containing the Moderna COVID-19 vaccine are prepared to be shipped at the McKesson distribution center in Olive Branch, Mississippi, December 2020
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.
Side effects are much rarer among those who have received the Johnson & Johnson vaccine, potentially due to the fact that it uses a different platform than Pfizer and Moderna. Pictured: Vials of the J&J vaccine at a vaccination operation organized by St John’s Well Child and Family Center in Los Angeles, California, March 25
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
This post first appeared on dailymail.co.uk