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Covid-19 and US vaccine rollout: news summary for 14 April

We bring you all the latest news and updates regarding covid-19 and the vaccine rollout in the United States with our live blog on Wednesday 14 April 2021.

US vaccine latest news live: Wednesday 14 April

Headlines

- Pfizer, Moderna, Johnson & Johnson covid-19 vaccines: know the difference

- More than 195 million doses have been administered in the United States, with over 270 million doses distributed, according to the CDC.

- 76.7 million people, or 23.1% of the total population, fully vaccinated.

- Around 124 million people, 37.3%  of the population, have received at least one dose.

- President Biden has arranged for 300 million doses to be available to US citizens by the end of June, says Dr Fauci.

- Estimations are that 500 million Americans will be fully vaccinated by the end of August/early September, with Biden previously suggesting that the US would be "approaching normalcy by the end of this year."

- Fauci says J&J vaccine rollout pause is a matter of "days to weeks, not weeks to months"

- CDC and FDA will continue to investigate J&J vaccine safety after six reported cases of rare clotting - cerebral venous sinus thrombosis- emerge.

- There are "tens of millions" of available vaccine doses in the US and the supply exists to "continue to vaccinate Americans who want to be vaccinated" says FDA.

- US will draw on stocks of Moderna and Pfizer after J&J rollout halted.

State specific news:

- New York: All New Yorkers 16 years of age and older are now eligible to be vaccinated. Use the City's Vaccine Finder to search for a location near you.

- California: Every Californian 16 and up will be eligible for vaccination from 15 April. Book an appointment using My Turn.

- Florida: All Florida residents are now eligible to receive any covid-19 vaccine. Find a vaccine location using the state's vaccine location finder.

- Texas: Everyone aged 16 and older is now eligible to receive a covid-19 vaccine in Texas. Sign up and register online at GetTheVaccine.dshs.texas.gov.

Related articles:

Memes and vaccines

Memes, the vaccines and disinformation

The BBC have taken a deep look at the use of memes to spread disinformation about the covid-19 vaccines, and specifically their safety. 

While a lot of the memes are clearly outrageous nonsense, the overall effect appears to be deleterious and the use of incorrect and misleading stats can lead people to start doubting the reality of the safety of the vaccines, which is incredibly high.

NYC covid-19 cases fall as vaccine rollout speeds up

New York City is at the forefront of the US' vaccination effort and it is thought that over 61% of adult residents have now received at least one shot. This is having a clear effect on coronavirus case numbers, with half as many elderly people hospitalised. In New Yorkers aged below 65, instances of hospitalisation have dropped by 29%.

NYC Health Commissioner Dr David Chokshi said during a press briefing on Wednesday: “The vaccines are life-saving, and here in New York City, we are starting to see them have the real world benefit that has been observed in Israel, the United Kingdom, and elsewhere."

What has Dr. Anthony Fauci said about the J&J vaccine pause?

The White House's  chief medical advisor, Dr. Anthony Fauci, has outlined the CDC and the FDA's decision to temporarily suspend use of the Johnson & Johnosn vaccine. Fauci described "a small number of adverse effects", adding that the decision had been made "out of an abundance of caution". 

CDC Johson & Johnson suspension to continue for at least a week

An emergency meeting held by an advisory committee for the CDC has decided that they need more time to study the possible consequences of reinstated the Johnson & Johnson vaccine that was paused in the US on Tuesday. They have decided not to vote on the shot's future now, but will meet again in 7-10 days to make their recommendation. 

This news comes after the FDA's announcement yesterday that they were studying cases of rare and severe blood clots in six women aged between 18 and 48. More than 7 million people in the United States have now received the shot in total. 

What are the facts about the J&J vaccine?

The Food and Drug Adminstration have moved to suspend use of the Johnson & Johnson vaccination while further research is done into links between the shot and blood clots. Dr Anthony Fauci has described the decision as a sensible precaution to ensure public trust in the pharmaceutical, but how many people have experienced the side effect so far?

As yet, there have been six reports of cerebral venous sinus thrombosis (CVST) in over 6.8 million doses, menaing that the risk currently stands at less than one in a million. Dr Eric Ding, Epidemiologist and Health Economist, runs through some of the stats here. 

Fauci gives statement on J&J vaccine pause

Dr Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases and the chief medical advisor to the president, has outlined the purpose of suspending the Johnson & Johnson vaccine.

In an interview with CNN, has described the two main intentions of the decision, both the give extra time to investigate the effects of the vaccine and to ensure that those who have already received a shot are cared for properly. Although the blood clot side effect has so far only been found in fewer than one in every million recipients, the White House is eager to assuage any fears about the vaccine. 

Can you drink alcohol after taking a covid-19 vaccine?

CORONAVIRUS VACCINE

Can you drink alcohol after taking a covid-19 vaccine?

Nearly 122,000,000 people in the United States are partially or fully vaccinated, but should you mark the occassion with a celebratory drink? Alcohol can have effects on the body which mirror some of the more minor possible side effects related to the vaccination. 

So far, the US Center for Disease Control and Prevention (CDC) has not released any concrete information on the topic. However the World Health Organisation has advised against it.

Read more

“The number of people who have been skittish about the vaccine has dropped as more Americans line up for the shot, but the hard core group who want to avoid it at all costs has barely budged. The recent news about J&J vaccines is probably not going to help that situation.

“On the other hand, it might not make it all that much worse since much of this reluctance is really ingrained in partisan identity.”

Patrick Murray, Director of the independent Monmouth University Polling Institute

Fox News chief slammed for vaccine conspiracy output

Rupert Murdoch, the 89-year-old boss of News Corp (which owns Fox, amongst other media corporations), has been criticised for his company's output when it comes to vaccine coverage. Murdoch himself was one of the first to receive a vaccination last December but some of the biggest names on his network have continually expressed doubts about the safety and efficacy of vaccines. 

CNN's senior media reporter Oliver Darcy accused Fox hosts of endangering the public by "recklessly telling viewers that the vaccines might not actually even work."

CDC Director on the Johnson & Johnson pause

In a online press conference for the White House's Covid-19 Response Team, CDC Director Rochelle Walensky has explained the reason for the pause on adminstering more doses of the Johnson & Johnson vaccine. 

Both the CDC and the FDA intend to carry out further study into the six reported instances of blood clots amongst recipients of the J&J vaccine, to better inform doctors about the risks. They will also look to find other examples of blood clots amongst patients who have had the vaccine and perfect a more general evaluation of the J&J shot. 

Fauci criticises Fox anchor for spouting conspiracy theory about vaccines

Tucker Carlson, one of the most prominent Fox News hosts, has been criticised by Dr Anthony Fauci for forwarding what he described a “crazy conspiracy theory” on his show on Tuesday evening. Tucker had suggested, without evidence that the Johnson & Johnson vaccine does not work, a claim that many fear will prevent many from receiving the life-saving shot. 

It comes as a recent study suggested that one in five Americans are not willing to get a vaccination to help protect themselves and others against the coronavirus. The Mommouth University poll notes that this is a slight fall from the number earlier this year. 

Fauci expains J&J vaccine "pause"

The government's chief pandemic expert , Dr Anthony Fauci, has outlined the reasoning behind the decision to suspend use of the Johnson & Johnson vaccine. The shot has been linked to a small number of cases of blood shots in recipients in recent weeks, known as cerebral venous sinus thrombosis.

In a White House briefing Dr Fauci was eager to point out that with only six confirmed cases so far the vaccine does not pose a significant threat to those who have received it, but the pause will allow the CDC and FDA additional time to study the potential side effect. It is thought that some groups, such as young women, may have been disproportionately affected so far. 

LIVE: watch the latest update from the covid-19 response team

The White House covid-19 Response Team is holding a briefing this morning a day after the announcement on the Johnson & Johnson vaccine pause.

The threat of anti-vaxx conspiracies

Fox News host Tucker Carlson is well-known for his ability to take one statement and turn it into something completely different, and dangerous. As Amanda Marcotte points out, his attitude here on vaccines is only going to harm the objective of fully returning to normal.

'Tucker's gambit here: "If vaccines work, why are vaccinated people still banned from living normal lives?" To be clear, he's lying. Vaccinated people are being told they can do more stuff. But it's still waaaaaay too cautious, giving credence to this rhetoric,' she tweets.

'Again, this isn't just talking out of the ass. Decades of sexual health approaches show that framing preventive care in terms of freedom and pleasure works better than dreary, anti-pleasure discourse. It worked with condoms, and will work with vaccines.'

Be careful who you listen to.

Vaccines, children and herd immunity

To halt covid-19 in its tracks, we need vaccines that stop the virus spreading as well as preventing people becoming seriously ill. Until now it was unclear how effective the vaccines are at doing this, but with vaccine roll-outs well under way, we are starting to get some answers.

The good news is that mRNA vaccines like Pfizer/BioNTech appear to be around 90 per cent effective at blocking transmission. The bad news is that as there are no plans to vaccinate children under 16 anytime soon.

Michael Le Page looks a little further down the line at the challenges to reaching herd immunity.

Global vaccine rollout

As Vincent Rakkumar highlights, over 45% of the eligible population in the United States (122 million out of ~265 million) have had at least one dose of covid vaccine.

Over 60% of people over age 65 have already been vaccinated.

Progress is being made.

Vaccine progress felt on Wall Street

US stock indexes rise at the opening on Wednesday after upbeat earnings reports from Goldman Sachs and JPMorgan boosted investor expectations of a strong rebound for corporate America amid swift covid-19 vaccinations.

Goldman Sachs Group Inc rose 1.5% as it reported a massive jump in first-quarter profit, capitalizing on record levels of global dealmaking activity.

JPMorgan Chase & Co's shares dipped 0.6% even as the largest US bank's earnings jumped almost 400% in the first quarter, as it released more than $5 billion in reserves it had set aside to cover coronavirus-driven loan defaults.

"It certainly is a solid quarter (for banks) ... often the stocks run up into news and then at least initial reaction is some profit taking and we were seeing that this morning in JPMorgan," said Rick Meckler, partner at Cherry Lane Investments in New Vernon, New Jersey.

"I think investors who have invested in the banking sector will feel good about the results and which are likely keep them invested in the sector."

"Go get your vacccine!"

It's a clear message from MSNBC analyst Matthew Miller who is feeling great after receiving his first shot.

What is a cerebral venous sinus thrombosis? Blood clot symptons and causes

VACCINE NEWS

What is a cerebral venous sinus thrombosis? Blood clot symptons and causes

While the fatal side effects of vaccines have been widely covered in the media, it is important to note that deadly outcomes are extremely rare and as yet it is not understood if there is indeed an actual link between the vaccine and a subsequent incident, nor the mechanism by which this could occur.

Individuals who forego vaccinations are much more likely to risk death by covid-19 than by getting vaccinated.

Maite Knorr-Evans looks at what cerebral venous sinus thrombosis is and what to watch out for.

Pfizer, Moderna and J&J/Janssen: who can get each, side effects, doses

CORONAVIRUS VACCINE

Pfizer, Moderna and J&J/Janssen: who can get each, side effects, doses

President Joe Biden has said that vaccination will be open to all Americans by 19 April. However, depending on where you live you might have access to only one of the three vaccines. Health officials say to get whichever vaccine is available to you. Getting vaccinated doesn’t just help you but everyone around you.

The Pfizer-BioNTech, the Moderna and Johnson & Johnson Janssen covid-19 vaccines have been given emergency approval for use in the US. However, use of the Johnson & Johnson has been suspended temporarily to study 6 severe cases of blood clotting.

Greg Heilman has done some digging to provide you with a useful summary on the various vaccines doing the rounds.

US vaccine supply update

As Drew Armstrong explains, 28 million doses have been allocated in the US this week, and it appears that this is all Pfizer and Moderna vaccines.

We've heard that Pfizer is saying it will accelerate deliveries to 220 million by end of May (an increase on the planned 200 million) and by the middle of July this should be a full 300 million.

Check out Bloomberg's very neat and interactive graphics tools to find out more.

J&J vaccine pause: what the experts say

"We're talking about an event that occurs in 1 in 1 million shots, versus if you catch covid, the chances of you being hospitalized are 1 in 100 for most people.

"These are orders of magnitude different."

That was the view of Dr. Alex Spyropoulos, a blood-clot specialist and professor at the Feinstein Institutes for Medical Research, the research arm of Northwell Health.

For more opinions, Andrew Dunn went looking...

Vaccine rollout gets NFL support

The NFL issued a memo to all team personnel that announced the league's plans to move forward with covid-19 vaccination education and accessibility and encouraged all players and staff to get vaccinated.

ESPN broke news of the memo, which came from NFL commissioner Roger Goodell,

John Mara, chair of the league's executive committee, and John York, chair of NFL's health and safety committee. It was addressed to all team chief executives, presidents, general managers and head coaches.

"In light of expanded vaccine eligibility, it is appropriate now to take further steps to educate about and promote vaccine availability and acceptance within the NFL," said the statement, which outlined a five-point plan for teams to implement the new league guidelines.

Steps include using each team stadium or training facility as a vaccination site for club staff, players and eligible family members; scheduling and participating in vaccine information session for staff, players and family; educating employees and promoting communications regarding the benefits of vaccination; and weekly reporting of the number of employees who have been vaccinated.

Check out how the NFL is using its facilities to help with the rollout.

Moderna vaccine: 90% at six months

Moderna have announced that their coronavirus vaccine was 90 percent effective six months after a person receives their second dose.

“Vaccine efficacy starting two weeks following the second dose and based on the updated adjudicated cases remains consistent with prior updates, including greater than 90% against all cases of covid-19, and greater than 95% against severe cases of covid-19,” the company announced.

Moderna is working for its vaccine to be fully approved by the US as it is only under emergency authorizations from the Food and Drug Administration.

“The Moderna team continues to make important progress with our covid-19 Vaccine,” Stéphane Bancel, CEO of Moderna, said. “The new preclinical data on our variant-specific vaccine candidates give us confidence that we can proactively address emerging variants.”

The study includes data from 900 coronavirus cases with over 100 of the cases being severe.

Read more:

Vaccine contradictions in the Trump camp

Shortly following the joint recommendation from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) on Tuesday to “pause the use” of the Johnson & Johnson COVID-19 vaccine, former President Donald Trump slammed the decision, accusing the FDA of favoritism toward Pfizer and its vaccine.

Tuesday morning, the two federal agencies issued a statement “recommending a pause in the use of this [Johnson & Johnson] vaccine out of an abundance of caution” as they review data “involving 6 reported US cases of a rare & severe type of blood clot in individuals after receiving the vaccine.” They note, importantly, that “these adverse events appear to be extremely rare” right now. Furthermore, they stated that over 6.8 million doses of the Johnson & Johnson vaccine have been administered throughout the US, as of Monday.

Check out the full story from Sara Carter.

How many Johnson & Johnson vaccines have been administered in the US?

US CORONAVIRUS NEWS

How many Johnson & Johnson vaccines have been administered in the US?

With the US Food and Drug Administration and the US Centers for Disease Control and Prevention having made the decision to pause the use of the Johnson & Johnson vaccine, an investigation now begins into the six recipients that developed a rare disorder involving blood clots.

But have many people in the US already received a shot of this covid-19 vaccine? We have a look.

J&J vaccine risk management

The chances of you suffering any adverse effects after taking the Johnson & Johnson vaccine appear to be extremely low.

But if you were given it recently, you may want to watch this video just to be informed of the potential feelings you may experience.

Fauci on the J&J pause

“I believe this is going to take days to weeks… I think we’re going to be hearing about a decision pretty quickly.”

If you'd like to hear from Doctor Anthony Fauci himself, you can listen to this attached video. According to Dr Fauci, he doesn't expect the J&J investigation to take too long.

Vaccine promotion

Another reminder from Devi Sridhar that when you are offered a covid-19 vaccine, you should smile, roll up your sleeve, and hold out your arm.

But the again, what would the Professor and Chair of Global Public Health at Edinburgh University Medical School know? Oh!

@GlobalHealthGP

7

Putin receives second vaccine dose

News has just broken through the international agencies that Russian President Vladimir Putin has received a second shot of the Russian covid-19 vaccine.

The 68-year old said he hoped Russians "will do the same and follow my example" of getting vaccinated amid slow domestic uptake of the country's covid-19 vaccines

 

EU not to extends Astrazeneca and J&J contracts

The EU Commission has decided not to renew covid-19 vaccine contracts next year with companies such as Astrazeneca and Johnson & Johnson (J&J), Italian daily La Stampa reported on Wednesday citing a source from the Italian Health Ministry.

“The European Commission, in agreement with the leaders of many (EU) countries, has decided that the contracts with the companies that produce (viral vector) vaccines that are valid for the current year will not be renewed at their expiry,” the newspaper reported.

It added that Brussels would rather focus on covid-19 vaccines using messenger RNA (mRNA) technology, such as Pfizer’s and Moderna’s.

Budesonide: a simple alleviation from covid-19?

As vaccination against covid-19 gathers speed, the end of the covid-19 pandemic is starting to hover on the horizon. But not everyone will take the vaccine and none of the jabs is 100% effective at preventing any illness at all.

Even where vaccination rates are high some people will, at some point, become infected. Results from a clinical trial in Britain published today show that budesonide, a cheap generic drug they can take at home, will make their illness slightly less miserable.

Budesonide is a corticosteroid drug widely used by people with asthma and chronic obstructive pulmonary disease, who take it using a palm-sized inhaler. Early in the pandemic doctors noticed that people with these conditions were under-represented among covid-19 patients. That looked odd, because they are particularly susceptible to other respiratory infections such as the flu.

Laboratory studies found that in Petri dishes budesonide inhibits replication of SARS-CoV-2, the virus that causes covid-19. Like steroids in general, the drug also has an anti-inflammatory effect. All these things suggested that it was worth trying in patients with covid-19.

More on this from The Economist.

Vaccines work!

Professor at the Department of Microbiology Icahn School of Medicine at Mount Sinai, Florian Krammer, has shared this graph showing the number of covid-19 cases in Israel.

He states that this graphic is proof that vaccines work, but several people have misunderstood what it is showing.

Just to be clear, this is a cumulative total of cases, therefore the flattening of the slope shows that there have been negligible new cases added.

Could vaccine cocktails prove more effective?

A major UK study examining whether covid vaccines can be safely mixed with different types of jabs for the first and second doses is to be expanded.

Researchers running the Com-Cov study, launched in February to investigate alternating doses of the Oxford/AstraZeneca and Pfizer vaccines for the first and second doses, will now include a shot of the Moderna or Novavax vaccines.

The study is examining whether mixing vaccines may give broader, longer-lasting immunity against the virus and new variants, and offer more flexibility in the administration of vaccines.

Sarah Marsh looks into how the researchers are taking this idea forward.

Valneva vaccine Phase III trails in the US

French biotech company Valneva SE announced positive data for the first part of a Phase 1/2 clinical trial of its inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001. Valneva has completed recruitment for the pivotal Phase III trial, VLA1553-301, of its single-shot chikungunya vaccine candidate, VLA1553.

The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the US will be eligible to receive a Priority Review Voucher (PRV).

A total of 4,131 adults aged 18 or above have been recruited across 44 sites in the US for the Phase III trial, VLA1553-301, which was launched in September 2020. If the trial results are positive, the trial is expected to support VLA1553’s licensure.

6

J&J statement on covid-19 vaccine

In case you missed it yesterday, Johnson & Johnson issued the following statement concerning their covid-19 vaccine:

"The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.

In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants.

We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.

The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider".

Vaccine efficacy assessed after J&J pause

Thousands of doses of the Johnson & Johnson vaccine have been put on hold over concerns about blood clots. In the Bay Area, about 20,000 doses of the Johnson & Johnson vaccine have been shelved for the time being in seven counties.

Dr. Monica Gandhi, Professor of Medicine at the University of California in San Francisco says that vaccines are still the best way to combat covid-19 and could provide immunity for a lifetime.

“If we look at past coronavirus that cause severe illness, not the ones that cause colds, I truly believe we are not going to need frequent boosters,” Dr. Ghandi told CBS News.

Could J&J situation affect vaccine confidence?

A point touched upon by Dr Fauci and Jeff Zients in last night's briefing was that the J&J vaccine suspension could have far-reaching effects in the US if the latest scare hits the confidence of the populace over the safety of the vaccine rollout as a whole.

According to a recent survey by NPR, one in four Americans do not want to take a covid-19 vaccine.  How could that change if more questions are highlighted?

5

FDA to scrutinize vaccine design behind shots linked to blood clots

With two covid-19 vaccines now under scrutiny for possible links to very rare cases of blood clots in the brain, US government scientists are focusing on whether the specific technology behind the shots may be contributing to the risk.

In Europe, health regulators said last week there was a possible link between the AstraZeneca Plc vaccine and 169 cases of a rare brain blood clot known as cerebral venous sinus thrombosis (CVST), accompanied by a low blood platelet count, out of 34 million shots administered in the European Economic Area.

The US Food and Drug Administration on Tuesday recommended temporarily halting use of the Johnson & Johnson vaccine after reports of six cases of CVST in women under age 50 among some 7 million people who received the shot in the United States.

Both vaccines are based on a new technology using adenoviruses, which cause the common cold, that have been modified to essentially render them harmless. The viruses are employed as vectors to ferry instructions for human cells to make proteins found on the surface of the coronavirus, priming the immune system to make antibodies that fight off the actual virus.

Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors, FDA officials said at a briefing on Tuesday.

The US agency will analyze data from clinical trials of several vaccines using these viral vectors, including J&J's Ebola vaccine, to look for clues.

None of the previous vaccines using viral vectors have been administered at close to the scale of the AstraZeneca and J&J covid-19 shots, which may explain why a potential link to blood clots only materialized during these massive vaccination programs.

The technology has also been used in coronavirus vaccines developed in China and Russia.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, was reluctant to declare the blood clot issues a "class effect" shared by all adenovirus vector vaccines, but he sees marked similarity in the cases.

"It's plainly obvious to us already that what we're seeing with the Janssen (J&J) vaccine looks very similar to what was being seen with the AstraZeneca vaccine," Marks said. "We can't make some broad statement yet, but obviously, they are from the same general class of viral vectors."

When are you fully vaccinated from Covid: which vaccines require two doses?

CORONAVIRUS

When are you fully vaccinated from Covid: which vaccines require two doses?

The United States vaccination drive is in full swing. More than 187 million doses have been administered in the United States, with 70 million people, or 21.5% of the total population, fully vaccinated. One third of the US population has now received at least one dose of the covid-19 vaccine.

"Our progress on vaccinations is proof that there’s nothing America can’t achieve when we do it together,” said Joe Biden following the publication of the latest vaccination report. His comments came after 4.6 million doses of the covid-19 vaccine were administered on Friday, 9 April, setting a new single-day record.

Estimations are that 500 million Americans will be fully vaccinated by the end of August/early September, with President Joe Biden previously suggesting that the US would be "approaching normalcy by the end of this year."

Find out more about when you can expect to be fully vaccinated depending on the vaccine you are given.

4

EMA reviewing blood clot reports

The European Medicines Agency (EMA) said on Tuesday it was reviewing cases of rare blood clots in women who had taken Johnson & Johnson's covid-19 vaccine after US federal health authorities recommended pausing the use of the shot.

In a statement to Reuters, the EMA said it was "currently not clear whether there is a causal association between vaccination" and the conditions.

"EMA will further communicate once the evaluation has concluded," it added.

South Africa suspends J&J vaccine

South Africa has temporarily suspended the rollout of Johnson & Johnson's covid-19 vaccine, its health minister said on Tuesday, after US federal health agencies recommended pausing its use because of rare cases of blood clots.

The US Food and Drug Administration (FDA) said the pause there was expected to be a matter of days. Six women under age 50 developed rare blood clots in the United States among more than 6 million people given the J&J shot so far.

"I had urgent consultations with our scientists, who advised that we cannot take the decision by the FDA lightly. Based on their advice, we have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated," Health Minister Zweli Mkhize told reporters.

He said there had not been reports of such clots in South Africa after almost 290,000 vaccinations.

In South Africa, the J&J vaccine has been given to health workers in a research study that is further testing it in the field. The government expects to receive its first batch of commercial doses later this month, as part of a bilateral deal with J&J for 31 million doses.

3

US has "more than enough vaccine" - Zients

White House covid-19 coordinator Jeff Zients said on Tuesday that the United States has more than enough vaccine from Pfizer Inc and Moderna Inc to keep up the pace of vaccinations during a pause in the use of Johnson & Johnson's shot.

US federal health agencies on Tuesday recommended pausing administering J&J's covid-19 vaccine for at least a few days after six women under age 50 developed rare blood clots after getting the shot, dealing a setback in efforts to tackle the pandemic.

"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," Zients said.

US infectious disease official Dr. Anthony Fauci said on Tuesday that the pause on J&J's vaccine is likely to last days or weeks, and that he could not rule out that the review would lead to a full stoppage of the vaccine.

Photo by Brendan Smialowski / AFP

J&J covid-19 vaccine pause: more reaction

Dr. Amesh Adalja, infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore. "It's important to remember the 'hold' is only on federal vaccine sites — not all.

"I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about, but the federal government has been overly cautious with many aspects of this pandemic.

"People are asking me if they should cancel their J&J vaccine appointments and I have told them not to. But I know many well and this will stall progress in controlling the pandemic."

J&J covid-19 vaccine pause: more reaction

Following are initial reactions Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh spoke about the situation.

"Whilst a causal link between covid vaccination, platelet abnormalities and blood clots has not, so far, been confirmed, the index of suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines.

"Whilst more data need to be collected, and the implications carefully considered, it remains the case that for the vast majority of people the risks associated with contracting covid-19 far, far outweigh any risk of being vaccinated.

"Moreover, increasing awareness of the possibility of such side-effects means that they should be diagnosed more quickly and treated more successfully."

"Benefits of J&J vaccine outweigh possible risks"

The Dutch medicines regulator (CBG) on Tuesday said the benefits of the Johnson & Johnson covid-19 vaccine outweigh the possible risks, after US federal health agencies recommended pausing the use of the shot.

"Together with the European Medicines Authority we are monitoring the situation very closely", the CBG said. "For now, the benefits of the vaccine outweigh the possible risks."

The US agencies made their recommendation after six recipients developed a rare disorder involving blood clots.

New Mexico pauses J&J vaccine

On Tuesday evening, New Mexico joined the growing number of states that have announced the suspension of the J&J vaccine until further notice.

We'll keep you posted on how this changes across different states over the coming days.

2

J&J vaccine pause recommendation is "not a mandate"

Doctors and patients can make their own decisions on administering and receiving the J&J vaccine and the FDA/CDC's recommendations are "not a mandate", according to an FDA official who spoke to CNN.

“It's out of an abundance of caution we're recommending that the vaccine be paused in terms of its administration,” said Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation & Research.

“However, if an individual health care provider has a conversation with an individual patient and they determine that the benefit risk for that individual patient is appropriate, we're not going to stop that provider from administering the vaccine, because it could be right in many cases that benefit risk will be beneficial overall to that individual. A provider and patient can make the determination whether or not to receive the vaccine."

J&J vaccine risk "very low" says CDC official

Dr. Anne Schuchat, principal deputy director of the CDC, has said that the risk for those who received the Johnson & Johnson coronavirus vaccine more than a month ago is "very low".

"I know there are people who have gotten the vaccine who are probably very concerned. For people who got the vaccine more than a month ago, the risk to them is very low at this time," Schuchat said at a press briefing.

"For people who recently got the vaccine within the last couple of weeks, they should be aware to look for symptoms. If you received the vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your health care provider," she added.

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White House statement on J&J vaccine

The White House has said that the FDA/CDC announcement calling for the temporary pause in the use of the Johnson & Johnson vaccine "willnot have 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," said Jeff Zients, the White House covid-19 Response Coordinator on the Johnson & Johnson Vaccine, in a statement.

"Based on actions taken by the President earlier this year, 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. 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."

J&J to delay vaccine rollout in Europe

Johnson & Johnson has announced it will delay the rollout of its Covid-19 vaccine in Europe.

The announcement followed US federal health authorities calling on States to pause the use of J&J vaccines as they investigate possible links with a rare blood clot disorder suffered by six recipients of the one-dose shot.

Meanwhile,  UK Healthcare says it is pausing use of the J&J vaccine following FDA recommendation.

FDA/CDC statement re. Johnson & Johnson vaccine

Here is the joint statement issued not long ago by the FDA and the CDC, in which it calls for the suspension of the rollout of the J&J vaccine:

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.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination 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. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA's YouTube channel.

Johnson & Johnson vaccine pause

There is no doubt that the biggest news in the world of vaccine's yesterday was that US federal health agencies called for an immediate pause in use of Johnson & Johnson's single-dose covid-19 vaccine. This came following six US recipients developing a rare disorder involving blood clots.

The blood-clot concerns surrounding J&J's covid-19 vaccine pose a new test for the world’s biggest health-products maker.

J&J has faced a number of thorny, headline-grabbing issues during its 135-year history, from cyanide poisoning of its Tylenol headache remedy to quality problems with several of the company’s over-the-counter products and cancer concerns about its talcum powder.

The company’s handling of the Tylenol poisoning burnished its reputation as a high-minded corporate citizen and became a business-school case study in how companies should handle crises, while its response to the over-the-counter quality problems hurt its standing among consumers and the company’s consumer-health business.

Jared S. Hopkins and Peter Loftus look at the latest challenge for the healthcare giant.

Covid-19 vaccine news: welcome

Hello and welcome to our dedicated live blog for Wednesday 14 April 2021.

Here we aim to keep you fully up to date with all the latest news and updates regarding the covid-19 pandemic and all aspects of the vaccine development and rollout across the United States.