PFIZER VACCINE SIDE EFFECTS
British regulators are advising that anyone who has a history of ‘significant’ allergic reactions to medicines, food or vaccines should not get the Pfizer coronavirus jab.
Allergic reactions to the vaccine are ‘very rare’, according to the trials involving more than 40,000 people.
Pfizer found a ‘very small number’ during its phase three clinical studies, or 137 out of 19,000 people who got the vaccine. But 111 people who were given a placebo also had allergic reactions.
They also identified 12 possible side-effects from the vaccine, with seven identified as ‘very common’ meaning they are likely to affect more than one in ten people. Below are the known side effects.
The patient safety leaflet for the vaccine cautions that anyone with an allergy to any of the active substances in the vaccine should not receive the jab.
Allergic reactions to the vaccine are:
Very common (Likely to affect more than one in ten people)
- Pain at injection site
- Muscle pain
- Joint pain
Common (Likely to affect up to one in ten people)
- Injection site swelling
- Redness at injection site
Uncommon (May affect one in 100 people)
- Enlarged lymph nodes
- Feeling unwell
There are fears over how safe Pfizer’s COVID vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock hours later, prompting British authorities to tell anyone with a ‘severe’ allergy to food or medicine not to get it.
The FDA is due to meet tomorrow to discuss green-lighting the vaccine in America after being lambasted for taking a week longer than the Brits to get it off the ground.
As of Tuesday, more than 15million people in the US had been diagnosed with COVID and the total number of deaths since the start of the pandemic reached more than 284,000. That number is expected to climb as a result of Thanksgiving travel and gatherings.
In a preliminary analysis posted online on Tuesday, one group of FDA scientists said it was safe.
Among the 20,000 people who were given the vaccine in Pfizer’s global trial, 137 had allergic reactions but so did 111 people who were given the placebo, leading scientists to dismiss it as a potential hazard.
Four people did get Bell’s Palsy after receiving it, a type of facial paralysis, but the trial scientists said it was not necessarily the jab that caused it and was on par with the general rate of Bell’s Palsy in the wider population.
But Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday warned people with a severe allergy to food or medicine not to get it.
In America, that applies to at least 200,000 people who have food allergies and many more who have drug allergies.
The two healthcare workers who were affected both carry EpiPens but no other information has been given. They are now said to be recovering well.
British scientists have told the public not to panic and say the vaccine is safe but there is still a large amount of skepticism surrounding it.
It also raises the question of whether the US was right to take longer in approving the shot, despite receiving pressure from Americans to give it the go-ahead because Britain had.
On December 3, Dr. Fauci warned that the Brits had moved too quickly.
‘In all fairness to so many of my UK friends, they kind of ran around the corner of the marathon and joined it in the last mile,’ he said.
‘I think that would be a good metaphor for that…because they really rushed through that approval. I love the Brits, they’re great, they’re good scientists, but they just took the data from the Pfizer company and instead of scrutinizing it really, really carefully, they said, ‘OK, let’s approve it, that’s it.’ And they went with it.
‘In fact, they were even rather severely criticized by their European Union counterparts who were saying, you know, ‘That was kind of a hot dog play,” he said.
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The UK approved the vaccine last week and started giving it out on Tuesday, but two NHS staff suffered allergic reactions to it. Above, Margaret Keenan, 90, becomes the first person in the world to receive it. She was given the vaccine on Tuesday morning in Coventry, England
Was he right all along? On December 3, Dr Anthony Fauci criticized the UK for approving Pfizer Inc’s coronavirus vaccine too quickly. He then apologized and said he only made the remarks out of competitiveness
He then apologized for his remarks and said they were driven by competitiveness.
‘It was just one of those things where I sat down in front of the TV with a British TV station and the first thing they said was, ‘Ah, we beat you guys. We beat the Americans to the punch’.
‘And I kind of reacted back at him when I think I probably should not have done.
‘When I got back on BBC I explained that that was taken out of context. Now the Brits are good.
‘They know what they’re doing – I mean they’re really pros, so that was just not really what I meant,’ he said.
If the vaccine is approved by the administration, it will continued to be monitored for safely purposes.
Health and Human Services Sec Alex Azar said on Wednesday morning said that the Trump administraton was working with the incoming Biden-Harris administration to put together a plan.
‘We’re collaborating very closely…all these distribution plans are minutely detailed.
‘It’s very well in hand,’ he told CBS This Morning.
‘Actually, we’re hoping within days we’ll start vaccinating Americans.
‘I actually think we’ll start seeing in February and March more general vaccinations, during the second quarter of next year we’ll have enough for all Americans.
‘It’s not like there’s a one-day event when all of a sudden vaccines become available,’ he said.
Operation Warp Speed Director of Supply, Lt. Gen. Paul Ostrowski (left) and Health and Human Services Secretary Alex Azar (right) both appeared on TV on Wednesday morning to insist the vaccine was safe
He added that the US was ‘waiting’ for Pfizer to ‘commit’ to selling 500million doses of the vaccine which would be enough for 250million people.
‘We’re actively negotiating to acquire more,’ he said, adding the administration would use the defense production act if necessary.
He said the US had contracts or was having talks with multiple companies, and that it was being ‘very aggressive’ in ‘spreading its bets around’.
There is already widespread skepticism over the vaccine and others.
Lt. Gen. Paul Ostrowski Dir. of Supply, Production and Distribution for Operation Warp Speed insisted on Wednesday morning that it was the ‘gold standard’ of safety.
‘We have to build trust in the American people,’ he told Good Morning America.
‘When my time comes, it’ll be my top priority along with my family,’ he added.
Nursing home residents and healthcare workers will be first in line but beyond that, there is no clear plan for giving out the doses.
Once approved, the US has a reported 100million doses of the vaccine from Pfizer which is enough to inoculate 50million people – that is only around 15 percent of the population.
According to Pfizer, the Trump administration passed up the opportunity to buy more doses back in the summer. His administration say it’s ‘false’.
The document will be reviewed on Thursday when the panel of experts convenes
The FDA scientists’ conclusion towards the end of the report that the vaccine meets safety and efficacy standards
A nurse adminsters the Pfizer-BioNtech Covid-19 vaccine to patient William ‘Bill’ Shakespeare, 81, at University Hospital in Coventry, central England, on December 8, 2020
British politician Matt Hancock cries on air on Tuesday as the first Britons received the vaccine. Meanwhile, it is still yet to be approved in the US, pending an FDA meeting on Thursday that could potentially give it the green-light
There are rumors he plans to sign an executive order making Americans a ‘priority’ for the vaccine, but members of Operation Warp Speed – the fast track vaccine task force – admitted on Tuesday they did not know what he meant.
WHY THE FDA IS TAKING SO LONG TO APPROVE PFIZER VACCINE
FDA Commissioner Steve Hahn said on Wednesday that scientists needed more time to review the raw data from the Pfizer vaccine trial before they’d make a decision.
Before December 10, when the will all meet to discuss it, this is what happens;
Multiple teams examine different data sets
Hahn said that ordinarily, 150 scientists would look at an application. It’s unclear if more have been added for the Pfizer application or the Moderna application given the urgency of the situation
They will separately look at data for different components of the vaccine including;
All the different groups will then come together on the 10th to discuss their findings and if, collaboratively, they can recommend approval
The FDA scientists make a recommendation to the advisory council
The advisory council has already started meeting to discuss who would get the vaccine first if it is approved.
They also have to decide, ultimately, if it is safe for approval.
If they do that, the doses will start being shipped out on December 15.
The FDA’s analysis of the vaccine showed the vaccine to be 95 percent effective against Covid-19 – matching the results published by the pharmaceutical giant Pfizer.
In order for it to be 95 percent effective, however, it does need two doses, the first jab was found to have prevented 89 percent of the most severe cases.
The analysis says that while there were no ‘meaningful imbalances’, four of the 22,000 people who got the vaccine then suffered facial paralysis – otherwise known as Bells palsy. They don’t attribute it to the shot.
Another 22,000 people were given a placebo and no one in that group suffered facial paralysis.
‘Among non-serious unsolicited adverse events, there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group, though the four cases in the vaccine group do not represent a frequency above that expected in the general population.’
Many of the people who were given the vaccine said they felt ill after receiving the second dose.
Half of all of the participants aged between 16 and 55 said they felt fatigue, more than half said they felt headaches, over a third felt chills and 37 percent felt muscle pain.
Half of everyone over 55 felt fatigues, a third felt headaches and a quarter felt chills. Only 29 percent felt muscle pain.
The New York Times reports that the Trump administration was offered the chance to buy more doses of the vaccine in the summer but that they passed.
Now, Pfizer has entered manufacturing deals with other countries which the Times says could make it more difficult for the US to get all of the vaccines they need.
On a call with reporters, a senior administration official said the Times’ report was ‘false.’
But the official did not address what was ‘false’ and said: ‘We feel absolutely confident we will get the vaccine doses for which we’ve contracted and will have sufficient number of doses to vaccinate all Americans who desire one before the end of second quarter 2021.’
Pfizer and Moderna both snubbed a vaccine summit at the White House that will take place on Tuesday.
STAT reported Monday that Pfizer CEO Albert Bourla and Moderna CEO Stéphane Bancel had been invited to appear in Washington and declined.
The White House is claiming that it decided instead to have Dr. Peter Marks, the leader of the Food and Drug Administration’s biologics center, as its guest and that he declined to appear at the event while Pfizer and Moderna’s vaccines were both still under review.
Trump’s camp had accused both Pfizer and Moderna of withholding how effective their vaccines were until after the election in an attempt to thwart his chances of success.
A new poll shows that in all, only 55% of Americans say they are likely to take a Covid-19 vaccine if it were available today
The poll shows 67% of men are likely to take the vaccine, while only 49% of women are similarly likely to get the the Covid-19 vaccine
President Donald Trump was incensed after good news on the coronavirus vaccine front came after the November 3 presidential election
They both denied it, saying there was nothing political about either announcement.
WHO WILL GET THE COVID-19 VACCINE FIRST AND WHEN WILL THEY GET IT?
Pfizer’s vaccine is now on track for potential emergency approval as soon as this month, but it won’t immediately go to all Americans.
Health care workers will be able to get the first doses in December or January, head of the Advisory Committee on Immunization Practices (ACIP) Dr Jose Romero told NPR.
Next, non-health care essential workers such as grocery store staff, elderly people and people with underlying conditions that put them at high risk for severe COVID-19 will probably get the vaccine.
They can likely get the vaccine early next year.
Elderly people include anyone over 65. People with heart disease, kidney disease, diabetes, obesity, cancer and autoimmune conditions are considered at-risk due to their medical histories.
It’s not clear in what order these next three groups will likely be vaccinated.
Dr Anthony Fauci said last month that the general public will likely start to get vaccinations ‘within the first quarter of 2021, by let’s see April of 2021,’ he told CBS Evening News.
U.S. officials have not yet made official recommendations for who should get the COVID-19 vaccine yet.
The ACIP will meet and make recommendations with in 24 to 48 hours of a vaccine getting emergency use authorization from the Food and Drug Administration (FDA).
Last week, the FDA was slammed for taking so long to approve the vaccine when it had already been approved in the UK.
Commissioner Steve Hahn defended the process, saying it was the safes and most ‘robust’ of any country in the world.
The first to get the vaccine, once approved, will be nursing home residents and healthcare workers.
Then, it will be down to the states to determine who goes next.
The vaccine is, according to the pharmaceutical firm’s research, 95 percent effective.
It’s still unclear how long protection lasts and some side effects have been reported like mild flu symptoms and headaches.
The briefing documents from the FDA encourage people to continue participating in the study so that can be examined.
One nurse who took it said she experienced the highest fever of her life afterwards.
Jefferies analyst Michael Yee in research note said the documents were ‘very simple and straightforward, which we think will lead to approval imminently.’
There were a total of six deaths in Pfizer’s late-stage trial of the vaccine, with two deaths among patients receiving the vaccine and the rest in those on a placebo, the documents showed.
All deaths represent events that occur in the general population at a similar rate, FDA staff said.
The FDA is expected to decide on whether to authorize the vaccine within days or weeks.
Pfizer shares rose nearly 1% to $41.66 before the bell. BioNTech’s U.S. shares were up 1.3% at $127.10.
They sky-rocketed when it was announced that the vaccine was as effective as it is, as did Moderna’s.
The vaccine roll-out comes as America hits its deadliest numbers.
The current seven-day rolling average of COVID-19 deaths in the United States has now surpassed what it was during the initial April peak – as America suffered its deadliest week since April with 15,658 deaths.
The US recorded 1,404 deaths and 192,299 new coronavirus cases yesterday, while the number of people currently hospitalized reached a record 102,148.
Deaths across the country, which have been rising rapidly since last month, are now currently averaging 2,200 per day.
During the initial peak of the virus in April, the highest seven-day rolling average was just over 2,000.
In the last week, 15,658 Americans have died from COVID-19 – making it the deadliest week in the pandemic since April.
The number of new cases has surpassed 200,000 every day in the last seven days with more than 1 million cases reported in the first week of December alone.
While fatalities surged back in April during the initial peak, they did not rise at the same rates when infections started surging across the Sun Belt states in summer.
Fatalities, which are a lagging indicator and can rise weeks after cases are diagnosed, remained below an average of 1,000 per day until a month ago when hospitals – mostly in the Midwest – warned they were reaching capacity.
Hospitalizations have consistently set single-day highs since late October and are currently rising in 31 states compared to 14 days ago, according to the COVID Tracking Project.
In the last week, every state apart from Utah and Montana have reported an increase in deaths compared to the previous seven days, according to a Reuters tally of state and county reports.
South Carolina saw a 204 percent increase in deaths with 213 new fatalities. Vermont’s death toll spiked by 200 percent with 12 new deaths in the last week.
The Dakotas, however, continue to record the most deaths per 100,000 across the country.
In the last week, South Dakota recorded an average of 2.7 deaths per 100,000 and North Dakota followed with 1.8 deaths, according to CDC data.
Johnson & Johnson may know whether its one-dose coronavirus vaccine works by January – ‘much earlier than expected,’ chief scientist says
Johnson & Johnson says it may have the results of its late-stage experimental coronavirus vaccine trial sooner than expected.
In an event held by the International Federation of Pharmaceutical Manufacturers and Associations on Tuesday, the company’s chief scientific officer Dr Paul Stoffels said the team is expected to release data no later than next month.
‘We are in the middle of a phase III study and even towards the end…of up to 60,000 people,’ Stoffels said.
‘The number will be determined by the incidence of the disease and, if very high, we might have results sooner than expected.
‘But we target for results of January both for safety and efficacy and we have already started certain submissions in Europe.’
It comes as it is revealed the Trump administration only ordered enough of Pfizer Inc’s two-dose coronavirus jab to vaccinate 50 million Americans and declined to order more last summer and now Pfizer is back ordered until June 2021.
This means J&J’s vaccine, which only requires one-dose, may help make up the deficit if it is approved by the US Food and Drug Administration (FDA).
‘At the moment, COVAX is a combination of high-, middle- and low-income countries so there is a different approach to different tiers,’ he said.
However, he did address a question about vaccine manufacturers not willing to share intellectual property and said it’s a false narrative.
‘In the case of vaccines at this moment in time, we as companies are developing a new technology and scaling up all at the same time,’ Stoffels said.
‘So at the moment, it’s not intellectual property. We are in the middle of innovating new technology, which didn’t exist before, but right now we’re focusing on getting the technology stable ourselves before transferring capabilities to others.’
J&J’s vaccines combines genetic material from the new virus with the genes of the adenovirus – which causes the common cold – to induce an immune response.
It is the same technology the company used to make an experimental Ebola vaccine for people in the Democratic Republic of Congo in late 2019.
Currently, J&J is in the final stage of its clinical trial to determine if its experimental single-dose COVID-19 vaccine can protect against the virus.
The Phase III study is one of the world’s largest coronavirus vaccine studies so far, testing the shot in up to 60,000 volunteers at more than 200 sites in the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
Unlike those of other drugmakers, J&J’s vaccine does not need to be frozen and may require only one dose instead of two.
Pfizer’s CEO Albert Bourla addressed this issue during the event, considering that his company’s vaccine needs to be stored at -94F (-70C) and can only be in the refrigerator for five days.
However, he said the company has special isothermic boxes with a GPS inside each one to track
‘I feel very comfortable about our ability to distribute the product at -70 right now,’ Bourla said.
‘I think everybody will see pretty soon that this is not a challenge, at least in countries that there’s basic infrastructure like a road, for example.’
He did add that Pfizer is working on a new formulation that will not require ultra-cold storage
Despite a later start to testing than some of its competitors, Stoffels told reporters in September that the study was large enough to yield answers by early next year.
In August, the US government signed an agreement to pay J&J more than $1 billion in exchange for 100 million doses of its vaccine.
The latest contract is priced at roughly $10 per vaccine dose, including a previous $456 million the government promised to J&J for vaccine development in March.
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