There are fears over how safe Pfizer’s vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock within hours of receiving the shot.
The FDA is due to meet tomorrow to discuss green-lighting the vaccine in America. In a preliminary analysis posted online on Tuesday, one group of scientists said it was safe and there was no mention of any type of allergic reaction.
It’s unclear what the two healthcare workers are allergic to but now, British regulators are telling people with ‘severe allergies’ not to get the vaccine until more is done to prove it is safe.
The two healthcare workers both carry EpiPens but no other information has been given.
There was no mention of any allergic reactions to the vaccine among the roughly 20,000 people who received it as part of Pfizer’s global trial. 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.
Now, it’s unclear if the two healthcare workers who went into shock are the only ones who had an adverse reaction, and what it means for them going forward.
The Pfizer vaccine comes in two injections. Whether or not they can now take the second or if it’s safe for them to is under scrutiny. It’s also unclear if they will now be able to take any other type of future Covid vaccine.
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.
Dr. Fauci at first said the Brits rushed it out. He then apologized for his remarks.
Concerns have been raised over an allergy risk to the Phizer Covid-19 vaccine after two healthcare workers suffered a reaction after receiving it on Tuesday. The warning comes the day before the FDA is set to meet on Thursday and potentially give the vaccine the green-light in the US
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
If the vaccine is approved by the administration, it will continued to be monitored for safely purposes.
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’.
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.
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.
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
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
The White House invited Psizer CEO Albert Bourla (left) and Moderna CEO Stéphane Bancel to Tuesday’s ‘Vaccine Summit,’ an invitation they both declined, according to STAT
They both denied it, saying there was nothing political about either announcement.
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.