'There's enough vaccine for every single solitary American': Biden plays down J&J shot suspension over blood clots and says he 'made sure' there's enough Pfizer and Moderna for everyone
- The FDA and CDC have called for Johnson & Johnson's single-dose vaccine to be paused in the U.S
- Seven million people in the U.S. have received the one-shot vaccine - the rate of those with blood clots is 0.0008 percent
- They are all women aged between 18 and 48; one has died and one is in the hospital in a critical condition
- People with J&J appointments will now be offered Pfizer or Moderna instead; they do not need to cancel
- Experts say you're more likely to be hit by a car then develop blood clots from the vaccine
- Five times as many people have died from COVID-19 in the US than do from blood clots every year
- Doctors are however warning anyone who feels sudden pain, shortness of breath, severe headache, abdominal pain, leg pain, or shortness of breath to seek medical treatment
- Experts say the pause will have a 'devastating' impact on the US vaccine program
- Shares of J&J - which enjoyed a boost when the vaccine was approved - dropped 3 percent on Tuesday
- The shot has been approved in the US for a month and the World Health Organization also approved it
- The rollout in Europe will now be delayed as a result of the blood clot which is causing a 'stroke like' illness
The White House tried to smooth over the sudden halt of the Johnson and Johnson COVID-19 vaccine on Tuesday, claiming it would not affect their goals to vaccinate the US despite health experts saying it clearly sets back the country's rollout.
President Biden said in the Oval Office on Tuesday: 'I made sure we have 600 million doses of the mRNA -- not of either Johnson & Johnson and or AstraZeneca.
'So, there is enough vaccine that is basically 100% unquestionable for every single solitary American,' he said.
Pfizer said it was ramping up production by 10 percent in light of the J&J halt. Now, it says it will deliver 220million doses by the end of May, sooner than expected, and 300million
The CDC and FDA said on Tuesday in a shock announcement that it was recommending a pause on the vaccine - the newest and most efficient in America - after six women out of the 7million people who have had it developed blood clots, and one died.
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 US 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.
The US has only fully vaccinated 28 percent 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 US is fifth rather than fourth.
Around 1million people a week (142,857 a day) are receiving the J&J vaccine. It is considerably less than the number receiving Pfizer and Moderna doses (5million a week, 714,285 a day).
President Biden said in the Oval Office on Tuesday: 'I made sure we have 600 million doses of the mRNA -- not of either Johnson & Johnson and or AstraZeneca. 'So, there is enough vaccine that is basically 100% unquestionable for every single solitary American,' he said
At a White House press briefing on Tuesday, Dr. Anthony Fauci was among health experts who claimed the pause would not affect the country's goal of reaching 200million vaccinated Americans by April 30, despite doctors saying it is inevitable
The J&J vaccine makes up around 5 percent of the total number of vaccines administered in the US. Slightly fewer than 7million people have had it so far. Another 10million doses of the J&J vaccine are currently in the US that have not yet been given out yet and in total, the US has ordered 200million
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.
At a White House press conference on Tuesday, White House COVID-19 coordinator Jeff Zients said: 'We have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day, and that puts us well on pace to meet the President´s goal of 200 million shots by his first 100 days in office.'
Dr. Anthony Fauci, the nation's leading COVID expert, added: 'If someone recently within days, I'd tell them - don't get an anxiety reaction. It's less than 1 in a million however pay attention, do you have symptoms?'
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 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.
'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.
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 would send people 'up in arms'.
Health experts also said it delivers a 'devastating blow' to the vaccine program.
Critics, including Trump, say the decision to halt the vaccine was made hastily and unfairly.
The women who developed blood clots are all aged between 18 and 48.
One of them - who has not been identified - died and another, who also hasn't been identified but officials say is in Nebraska, is in a critical condition.
The experts do not yet know if the six women affected have other underlying illnesses - including if they take the oral contraceptive pill which is known to increase a woman's chances of developing blood clots - and they also do not know how long the pause will last.
One of the biggest problems is not the blood clotting itself, but that traditional treatments like heparin can cause 'tremendous harm' or be 'fatal' if the patient recently had the J&J vaccine.
There is now criticism over the pause which has sparked fear among those who have already had the vaccine, confusion among people who are yet to get it (since it has not been completely banned), and increased hesitancy among those who were already skeptical.
Former President Donald Trump said it was a 'disservice' to the country and the world that the FDA and CDC are being allowed to pause it but not ban the vaccine saying it clouds the entire vaccine effort with confusion and hurts J&J's brand.
'The Biden Administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a 'pause' in the use of the Johnson & Johnson COVID-19 vaccine.
The results of this vaccine have been extraordinary but now it's reputation will be permanently challenged,' he said in a statement, adding that it could be a 'political' decision driven by the FDA's 'love for Pfizer'.
Now, it's down to individual states, cities, healthcare centers and even doctors to decide whether or not to give it to someone or what to offer them instead.
The FDA and CDC says people who received the vaccine more than a month ago do not need to worry but 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.'
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
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.
'It is is a recommendation - it is not a mandate. However, if an individual healthcare provider has a conversation with a patient and they determine the benefit risk for that patient is appropriate, we're not going to stop that provider from administering the vaccine.
'It could be the benefit risk would be beneficial. We're recommending a pause but on an individual basis, a provider and patient can make a determination on whether or not to receive the vaccine,' Peter Marks, Director of the FDA Evaluation and Research, said on a call with reporters.
Anne Shuchat, Principal Deputy Director of the CDC said: 'I know the information we're providing is going to be very concerning.
'I want to let you know what were doing to learn more and protect people in the meantime, there has been six reports of a severe, stroke-like illness linked to low platelet counts. More than 6million doses have been administered so far.
While these events are very rare, we're recommending a pause in order to prepare the healthcare system to recognize and treat patients appropriately.
'This pause will also allow the CDC's expert committee to review the situation. The safety of the American people is of the utmost importance to us.'
'These symptoms are different from the flu-like symptoms that many people experienced in the days after the vaccine,' she said.
After the US pause on Tuesday, J&J announced it was halting its roll-out in Europe, where it was due to become widely available in the summer.
The UK has ordered 30million doses of the vaccine already.
Jeff Zients, counselor to the president, said it '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 country.
Shuchat said on Tuesday morning that there were none of these problems with Pfizer or Moderna, and that the agency is now working to reschedule appointments for people who received the J&J vaccine to get one of the alternatives.
'This may be a bit bumpy,' she admitted.
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. 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.
J&J shares dropped by almost 3 percent after the announcement from the two federal agencies on Tuesday
'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.'
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.'
The two agencies will hold a press conference at 10am EST to discuss the issue and a panel will convene on Wednesday too.
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.
Former President Donald Trump released a statement saying people would be understandably 'up in arms' after the announcement.
'The Biden Administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a 'pause' in the use of the Johnson & Johnson COVID-19 vaccine.
The results of this vaccine have been extraordinary but now it's reputation will be permanently challenged.
'The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it's the FDA's love for Pfizer.
'The FDA, especially with long time bureaucrats within, has to be controlled. They should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it.
'They'll do things like this to make themselves look important.
'Remember, it was the FDA working with Pfizer, who announced the vaccine approval two days after the 2020 Presidential Election,' he said.
'They didn't like me very much because I pushed them extremely hard.
But if I didn't, you wouldn't have a vaccine for 3-5 years, or maybe not at all. It takes them years to act!
'Do your testing, clean up the record and get the Johnson and Johnson vaccine back online quickly.
'The only way we defeat the China Virus is with our great vaccines,' he said.
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.
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.
'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.
This is how the vaccine effort in the US is ramping up. Around 20 percent of the population has now been vaccinated
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