Covid vaccine side effects: The lesser-known after effect symptoms caused by the vaccine

James Martin discusses problems getting his coronavirus vaccine

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The unprecedented vaccine rollout effort to help with the Covid pandemic has generated a stream of data about the possible side effects of each vaccine. What are the lesser-known side affects you need to know about?

Swollen lymph nodes

As more people are getting vaccinated, doctors are seeing an influx of women making mammogram appointments after noticing swollen lymph nodes in the arm region where they got vaccinated, according to ABC News.

Two days after getting the second Pfizer vaccine, Julie Mazenko felt a golf-ball size lump in her armpit.

She explained: “It was kind of painful and I touched and noticed that it was full of fluid.”

She then noticed a second swollen node in her neck and a third in the other arm.

READ MORE: Covid vaccine update: Third jab to be offered to over-50s in the autumn

Dr Laura Esserman is the director of UCSF’s Breast Care Center and says Julie is not alone.

They’re getting an influx of calls from women who are confusing swollen lymph nodes after the vaccine for signs of cancer.

“The lymph nodes when they get swollen, if you have an infection, are just doing their job. In the case of a vaccine, they are manufacturing the antibody for your body which is what you want,” said Dr Esserman.

Most people get their vaccine in the shoulder area which is a part of the body with around 20 – 40 lymph nodes in that region.

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Fatigue and headaches

The latest data from ZOE Covid Symptoms Study app looked at self-reported symptoms from 627,383 people after a jab between 8 December and 10 March.

The data found one in four people experience ‘mild, short lived’ side effects that mostly peaked within 24 hours and lasted one or two days.

The most common symptom was a headache, reported by eight percent and 13 percent after the first and second Pfizer dose, and 23 percent after the first AstraZeneca dose.

This was followed by fatigue, among eight percent and 14 percent of participants after the first and Pfizer dose, and 21 percent after the first AstraZeneca dose.

Reported side effects of COVID-19 vaccines have mostly been mild to moderate and have lasted no longer thana few days.

Typical side effects include pain at the injection site, fever, fatigue, headache, muscle pain, chills and diarrhoea.

The chances of any of these side effects occurring after vaccination differ according to the specific vaccine.

 Individuals should alert their local health providers following vaccination if they experience any unexpected side effects or other health events – such as side effects lasting more than three days.

Less common side effects reported for some COVID-19 vaccines have included severe allergic reactions such as anaphylaxis; however, this reaction is extremely rare. 

Side effects were more likely after the first dose of the AstraZeneca jab – with 13.5 percent of participants reporting symptoms after their first Pfizer dose, 22 percent after the second Pfizer dose and 34 percent after the first AstraZeneca dose, it also found.

Participants who’d previously had Covid-19 were also three times more likely to have side effects after the Pfizer vaccine and twice as likely after the AstraZeneca jab.

In addition, side effects were more common among people under 55 years of age and among women.
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J&J coronavirus vaccine can resume in US, CDC advisory panel recommends

A Centers for Disease Control and Prevention (CDC) advisory panel voted to recommend that the U.S. resume administering the Johnson & Johnson vaccine for people 18 years of age and older. This comes after an 11-day pause in administering the vaccine prompted by reports of extremely rare, but severe, blood clots that developed post-vaccination in a handful of people.

During an Advisory Committee on Immunization Practices meeting held on Friday (April 23), the panel voted 10 to 4 to resume Johnson & Johnson vaccination among all age groups, but they recommended that a warning label be added to include the possibility that the vaccine may increase the risk of such blood clots. 

Now, the CDC will decide whether to accept the recommendation, according to NBC News.

The CDC and the Food and Drug Administration (FDA) had recommended a pause in Johnson & Johnson vaccinations in the U.S. on April 13 to investigate six cases of the rare clotting disorder recently coined as “thrombosis with thrombocytopenia syndrome” (TTS). In the week and a half since, officials have confirmed another nine cases, bringing the total to 15.

That’s only a tiny proportion of the more than 8 million people who have been given the Johnson & Johnson vaccine in the U.S. so far, according to the CDC.  Of those cases, 13 were women between the ages of 18 and 49, and two were women who were 50 years of age or older. That means for women between the ages of 18 and 49, the risk of developing such blood clots appears to be 7 per million, and the risk for women who are 50 years of age or older appears to be 0.9 per million. There are another 10 cases that are currently under review, which may include males, according to the presenters at the ACIP.

Three of those patients died and seven remain hospitalized. There wasn’t a clear trend in risk factors among those who developed TTS other than being younger and female; seven were obese; two had hypothyroidism; two were using oral contraceptives; and two had high blood pressure.

The group discussed a spectrum of options for how to proceed with Johnson & Johnson vaccinations in the U.S., including continuing the recommendation that the vaccine can be given to everyone 18 years of age and older and the option of setting an age limit since the cases of TTS appear more common in younger populations.

CDC scientist Dr. Sara Oliver presented risk/benefit modeling on these various scenarios. Their modeling suggests that continuing the Johnson & Johnson vaccine for everyone ages 18 and older may cause 26 to 45 cases of TTS but would prevent 600 to 1,400 deaths and 800 to 3,500 intensive care unit (ICU) admissions. It would also allow flexibility and ability to vaccinate harder-to-reach populations.

If they recommend the vaccine just for people 50 years of age or older, it would likely lead to two or three cases of TTS and prevent 300 to 1,000 ICU admissions and 40 to 250 deaths.

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The experts did not see a good reason to stop using the Johnson & Johnson vaccine completely or limit its use to certain age groups. The discussion mainly centered around whether to recommend the Johnson & Johnson vaccine to everyone ages 18 and older or recommend it with a warning that women under the age of 50 “should be aware” of the increased risk of TTS and have an option of choosing another COVID-19 vaccine. 

The Johnson & Johnson vaccine is an adenovirus-based vaccine that’s similar to the one developed by AstraZeneca and the University of Oxford. The AstraZeneca vaccine has also prompted cases of TTS and was paused across many countries while being investigated; most countries have resumed administering the AstraZeneca shot but with various age restrictions and guidelines, Live Science previously reported.

Of the more than 214 million doses of mRNA vaccines — those made by Moderna and Pfizer — administered in the U.S., there have not been any reports of TTS.

On Tuesday (April 20), the European Medicines Agency concluded that there is a possible link between the J&J vaccine and rare cases of these blood clots and that a warning should be added to the product information; Johnson & Johnson announced the same day that it will resume shipment of its vaccine to the European Union, Norway and Iceland.

Originally published on Live Science.

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French-Austrian COVID vaccine in last trial stage

COVID vaccine

French-Austrian vaccine developer Valneva on Wednesday announced that it had launched a Phase 3 trial of its candidate vaccine against COVID-19—the last testing stage before seeking regulatory approval.

The study, which has been dubbed “Cov-Compare”, will compare how participants’ immune systems respond to Valneva’s VLA2001 vaccine with how they respond to AstraZeneca’s coronavirus shot.

“Approximately 4,000 participants will receive two doses of either vaccine,” said Valneva, adding that the study would be carried out at around 25 sites in the United Kingdom.

The main objective of the study is to show the superiority of VLA2001 compared to the AstraZeneca shot two weeks after vaccination, in terms of the level of antibodies that fight the coronavirus, the company added.

If the results of the trial are positive, “Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.”

Unlike most high-profile coronavirus shots, which use various methods to prime the immune system to fight the coronavirus, Valneva’s version is based on an “inactivated” version of the coronavirus itself.

The company said earlier Wednesday that it would “deprioritise” centralised talks with the European Commission to supply its coronavirus shot across the 27-nation EU, switching instead to “a country by country basis”.

Chief executive Thomas Lingelbach complained of a lack of “meaningful progress” in talks with the European Commission.

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Spain to Test Mixing COVID Vaccines After Restricting AZ Shot

MADRID (Reuters) – Spain will study the effects of mixing different coronavirus vaccines, government researchers said on Monday, responding to shifting guidelines on the safety of the AstraZeneca’s shot.

Along with several other European countries, Spain restricted vaccines produced by the Anglo-Swedish drug maker to people over 60 after regulators linked it to a rare form of brain blood clots, mostly in younger women.

“After decisions by various European public health authorities to suspend use of the AstraZeneca vaccine in under 60 year olds, we are setting out to urgently find scientific evidence to support decision making around possible alternatives,” Raquel Yotti, director of the Carlos III Health Institute, told a news conference.

The trial will draw on a sample of 600 people of all ages from across Spain, said Jesus Frias Iniesta, clinical research coordinator at Carlos III.

“The study’s objective is…to determine within 28 days whether a second dose of the Pfizer vaccine can be given to patients who have received the AstraZeneca vaccine,” he said.

A UK study on mixing vaccines was expanded last week to include shots made by Moderna and Novavax, while France and Germany are considering giving an alternative to under 60s who received a first dose of AstraZeneca.

Separately, Spain’s El Mundo newspaper reported the health ministry was considering delaying second doses for under 80 year olds to maximise the number of people who received at least one injection.

Patients would receive a second shot of vaccines produced by Pfizer and Moderna eight weeks after the first, El Mundo said. The European Medicines agency recommends a 28-day gap between Moderna shots and 21 days between Pfizer.

The proposal would signal a sharp departure from the current national strategy, which favours giving vulnerable age groups a full course of two shots as quickly as possible.

The Health Ministry was not immediately available for comment.

Several real-world studies have shown a first dose of the Pfizer-BioNTech vaccine provides a high level of protection.

Despite delays to the deployment of the one-shot Johnson & Johnson vaccine and supply disruptions at AstraZeneca, Spain still expects to have half its 47-million population fully inoculated by late July.

Data released on Friday showed 7% of the population had received a full course, while 19% had received at least one dose.

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COVID Vaccine Makers Have More Than Boosters in the Works

 

Vaccine boosters are part of the plan to protect against COVID-19 and emerging variants, but so are entirely new approaches to vaccination, including delivery routes that eliminate the need for injections, and easier storage to help ease vaccine supply shortages.

Next-generation COVID vaccines will have many different targets. Read what developers are investigating next.

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Why it’s important to call the Johnson & Johnson vaccine review phase a ‘pause’

Why it's important to call the Johnson & Johnson vaccine review phase a 'pause'

As the distribution of the Johnson & Johnson vaccine remains on hold while federal health officials review a potential blood-clotting side effect, public health authorities and scientists find themselves in a delicate position when it comes to the messaging about the safety and efficacy of COVID-19 vaccines to the United States public, two Northeastern scholars of public health law and communications say.

Last week, the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration said they were reviewing reports of six cases in which women who received the single-shot vaccine developed a rare, dangerous blood-clotting disorder. It’s not clear yet whether the vaccine is related to or caused the health condition, and the CDC recommended pausing its distribution “to be extra careful,” according to the announcement.

Public health officials and Northeastern researchers Wendy Parmet and Susan Mello are concerned that the pause, if it’s not communicated clearly, might be the tipping point for members of the public who were already hesitant about getting a COVID-19 vaccine to decide not to get inoculated against the highly contagious disease.

“I think regulators have to thread a very fine needle, and they’re doing so in a moment that is very fraught,” says Parmet, Matthews distinguished university professor of law and director of the Center for Health Policy and Law at Northeastern.

“We have a pandemic that is still very much raging in some parts of the country, we have a very active anti-vaccination movement and a significant percentage of the population outside of the movement who are hesitant of vaccines in the first place,” she says. “We’re in a pickle here.”

Such an effect could have widespread consequences as the U.S. races to vaccinate enough of the population to reach herd immunity—the threshold at which enough people are immune to a disease to suppress its spread and protect more vulnerable populations.

“This is exactly what you didn’t want to happen, in terms of potential side effects,” says Mello, assistant professor of communication studies whose research includes risk perception and health communication.

But, she says, there are early indications that public health officials are successfully navigating this communications quagmire.

Mello says that both health authorities and journalists are stressing the rarity of the blood clots—6.8 million doses of the vaccine have been administered and only six cases of clotting have occurred, making the odds more than one in a million.

“People will often think of themselves as that one, though,” Mello says, which is why it’s also important that officials stress the relative risk.

The odds are significantly higher that people who use oral contraceptives will develop similar blood clots, “and people have been taking birth control for years,” Mello says. And the odds of developing blood clots after being hospitalized for COVID-19 are roughly one in five.

“What we’re seeing is that you’re much more likely to contract COVID-19, and then much more likely to experience blood clotting from the disease than you ever are from getting the vaccine,” Mello says.

Anthony Fauci, considered among the top infectious disease doctors in the U.S., expects Johnson & Johnson to get its vaccine “back on track” shortly, after which it would become available to the public once again, although perhaps to a more specific portion of the population, if the instances of blood clotting in young women is associated with the vaccine.

Because it’s likely to be back, Mello says the use of the word “pause,” instead of something more finite, was a good choice.

After all, Parmet says, public opinion on matters related to health aren’t as crystalized as they may have become on other social and political issues.

“There’s a significant portion of the population who may have inclinations and questions, but what studies have shown is that people can change their minds over the course of engagement with medical information provided by their doctors,” she says.

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Pfizer CEO says a THIRD Covid vaccine may be needed

BREAKING NEWS: Pfizer CEO says a THIRD Covid vaccine dose will be needed as soon as six months after someone receives two shots – and then be vaccinated annually

  • Pfizer CEO Albert Bourla said it is ‘likely’ people will need a booster shot of the COVID-19 vaccine
  • The potential booster shot will be given within 12 months of someone being fully vaccinated
  • Bourla said it is possible that people will need to be immunized against the novel coronavirus annually

Pfizer Inc’s CEO says he believes people will ‘likely’ need a third dose of the COVID-19 vaccine. 

During a panel discussion hosted by CNBC in conjunction with CVS Health taped on April 1, Albert Bourla said a potential booster shot would be administered six to 12 months of being fully vaccinated.  

Bourla added that he thinks it is possible that people will need to be immunized against coronavirus annually.    

‘There are vaccines that are like polio that one dose is enough…and there are vaccines like flu than you need every year,’ he said in the segment, aired on Wednesday.

‘The Covid virus looks more like the influenza virus than the polio virus.’  

Pfizer CEO Albert Bourla said it is ‘likely’ people will need a booster shot of the COVID-19 vaccine

Pfizer and its German partner BioNTech began studying a third dose of their vaccine in late February.

The booster shot is aimed at protecting against future variants, which may be better at evading antibodies from vaccine than earlier strains of the virus.

About 144 volunteers will be given the third dose, mostly those who participated in the vaccine’s early-stage U.S. testing last year.

The vaccine uses part of the pathogen’s genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.

In the jab, known as BNT162b2, the mRNA encodes for all of the spike protein found on the outside of the virus that it uses to enter and infect cells.

It was authorized for emergency use by the U.S. Food and Drug Administration (FDA) after a clinical trial involving 44,000 volunteers found the shot was 95 percent effective at preventing symptomatic COVID-19. 

Real-world data six months later showed that the vaccine offered 91 percent protection six months later. 

However, the company’s current two-dose regimen produced a weaker immune response against the South African variant.

This is a breaking news story and will be updated.

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Updated Moderna vaccines neutralize South African SARS-CoV-2 variant in mice

Researchers in the United States have conducted a pre-clinical study demonstrating the efficacy of two updated versions of the Moderna mRNA-1273 vaccine against variants of severe acute respiratory syndrome coronavirus 2 – the agent that causes coronavirus disease 2019 (COVID-19).

Study: Variant SARS-CoV-2 mRNA vaccines confer broad neutralization as primary or booster series in mice

The updated vaccine candidates include the monovalent mRNA-1273.351, which is designed to target the B.1.351 variant that emerged in South Africa, and the multivalent mRNA1273.211, which comprises a mixture of the original mRNA-1273 vaccine and mRNA-1273.351.

The vaccines were evaluated in mice as both a primary vaccination series and as a booster dose among animals that had previously been immunized with two doses of mRNA-1273.

The team reports that while the mRNA-1273.351 vaccine elicited high levels of neutralizing antibody titers against B.1.351, the multivalent mRNA-1273.211 was most effective at providing broad cross-variant neutralization.

In addition, a booster dose of mRNA-1273.351 dramatically increased neutralization titers against both wild-type SARS-CoV-2 and the B.1.351 variant.

“Both mRNA-1273.351 and mRNA-1273.211 are currently being evaluated in additional pre-clinical challenge models and in phase 1/2 clinical studies,” says the team from Moderna Inc and the National Institute of Allergy and Infectious Diseases.

Global surveillance for the emergence of further variants of concern (VOCs) is also ongoing, as are efforts to test the ability of mRNA-1273 to neutralize VOCs.

“If additional variants emerge that reduce the neutralization capacity of mRNA-1273 further, additional mRNA vaccine designs may be developed and evaluated,” writes Kai Wu and colleagues.

A pre-print version of the research paper is available on the bioRxiv* server, while the article undergoes peer review.

Model of S protein. mRNA-1273.351 encodes the B.1.351 lineage S variant. Surface representation of the trimeric S protein in the vertical view with the locations of surface-exposed mutated residues highlighted in red spheres and labeled on the grey monomer. The inset shows superimposition of ACE-2 receptor domain and the RBD. S protein structure, 6VSB. ACE2-RBD structure, 6M0J. ACE2, angiotensin converting enzyme 2; NTD, N-terminal domain; RBD, receptor-binding domain.

Variants increasingly pose a threat to vaccination

The emergence of SARS-CoV-2 variants has raised concerns that the virus may have evolved the ability to escape vaccine-induced immunity. Several variants have demonstrated resistance to neutralization by vaccinated sera, particularly the South African B.1.351 lineage that was first identified in December 2020.

The initial stage of the SARS-CoV-2 infection process is mediated by the viral spike protein, which attaches to the host cell receptor via its receptor-binding domain (RBD). This spike RBD is the primary target of the neutralizing antibodies that are generated following infection or vaccination. A neutralization “supersite” has also been identified in the N-terminal domain (NTD) of the spike protein.

Studies have shown that several recently emerged SARS-CoV-2 variants harbor mutations in the RBD and NTD of spike that may confer resistance to vaccine-induced neutralization activity.

“Importantly, mutations in the NTD domain, and specifically the neutralization supersite, are extensive in the B.1.351 lineage virus,” says Wu and colleagues.

Furthermore, “studies have demonstrated reduced neutralization titers against the full B.1.351 variant following mRNA-1273 vaccination,” they add.

What did the researchers do?

Now, Wu and colleagues have evaluated the efficacy of two updated vaccines.

The monovalent mRNA-1273.351 vaccine encodes the spike protein found in the B.1.351 lineage, while the multivalent mRNA-1273.211 comprises a 1:1 mix of mRNA-1273.351 and mRNA-1273.

The original mRNA-1273 vaccine targets the ancestral wild-type virus (Wuhan-Hu-1 variant) that contains a mutation called D614G.

The vaccines were administered in mice as a two-dose primary series and their immunogenicity against D614G and B.1.351 pseudoviruses was evaluated 2 weeks following the first and second immunizations.

The mRNA-1273.351 vaccine was also evaluated as a booster dose in animals that had previously received two doses of mRNA-1273.

What did the study find?

Vaccine mRNA-1273.351 elicited approximately 4-fold higher neutralization titers against B.1.351 than against D614G.

Vaccine mRNA-1273.211, on the other hand, elicited robust neutralization responses against both D614G and B.1.351, with no significant difference observed in neutralization titers.

“Thus, as a primary vaccination series, a multivalent approach appears most effective in broadening immune responses,” says the team.

Next, the researchers tested the ability of mRNA-1273.351 to serve as a booster shot for neutralization against both D614G and B.1.351.

Mice were injected with mRNA-1273 on days 1 and 22 and then evaluated for antibody responses over the course of 7 months before being vaccinated a third time with mRNA-1273.351.

Following this booster injection, neutralization titers against D614G increased 4.5-fold, while titers against B.1.351 increased 15-fold.

The mRNA-1273.351 vaccine is an “effective booster”

“mRNA-1273.351 is an effective third (booster) dose in animals previously vaccinated with a primary vaccination series of mRNA-1273,” says Wu and the team.

“Ongoing studies will evaluate the ability of mRNA-1273, mRNA-1273.351, and mRNA-1273.211 to effectively boost immunity driven by a primary vaccination series of mRNA-1273,” they add.

The team says the mRNA platform approach against SARS-CoV-2 VOCs has now been demonstrated in mice to effectively broaden neutralization across variants and boost antibody levels when applied as a third dose.

“The mRNA platform allows for rapid design of vaccine antigens that incorporate key mutations, allowing for rapid future development of alternative variant-matched vaccines should they be needed,” writes Wu and colleagues.

“Additional VOC designs can be rapidly developed and deployed in the future if needed to address the evolving SARS-CoV-2 virus,” they conclude.

*Important Notice

bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Journal reference:
  • Wu K, et al. Variant SARS-CoV-2 mRNA vaccines confer broad neutralization as primary or booster series in mice. bioRxiv, 2021. doi: https://doi.org/10.1101/2021.04.13.439482, https://www.biorxiv.org/content/10.1101/2021.04.13.439482v1

Posted in: Medical Research News | Disease/Infection News

Tags: ACE2, Allergy, Angiotensin, Antibodies, Antibody, Cell, Coronavirus, Coronavirus Disease COVID-19, Efficacy, Enzyme, Infectious Diseases, Mutation, Protein, Receptor, Research, Respiratory, SARS, SARS-CoV-2, Severe Acute Respiratory, Severe Acute Respiratory Syndrome, Spike Protein, Syndrome, Vaccine, Virus

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Sally Robertson

Sally first developed an interest in medical communications when she took on the role of Journal Development Editor for BioMed Central (BMC), after having graduated with a degree in biomedical science from Greenwich University.

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U.S. pauses J&J COVID-19 vaccine over rare blood clots

(Reuters) -U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six women under 50 given the shot developed rare blood clots, dealing a fresh setback to efforts to tackle the pandemic.

FILE PHOTO: A woman receives a dose of the Johnson & Johnson coronavirus disease (COVID-19) vaccine during a visit of U.S. Vice President Kamala Harris to a vaccination center in Chinatown, in Chicago, Illinois, U.S., April 6, 2021. REUTERS/Carlos Barria

Following the news, Johnson & Johnson (J&J) said it was delaying the rollout of the vaccine to Europe, a week after regulators there said they were reviewing rare blood clots in four recipients of the shot in the United States.

The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

J&J’s single dose vaccine – most COVID-19 shots are delivered over two doses – and AstraZeneca’s low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

The White House said the pause would not have a “significant” impact on its plan to administer about three million shots per day and a total of 200 million shots before President Joe Biden’s 100th day in office.

The U.S. Food and Drug Administration (FDA) said one person had died from the rare blood clotting condition after taking the J&J vaccine and another was in a critical condition.

Immunology experts stressed the risk posed by the J&J vaccine appeared extremely low, and that the shot remained a valuable tool against the risks of COVID-19. However they acknowledged the need for health officials to proceed with caution to understand the best ways to mitigate any risk.

“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,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

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

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FDA acting commissioner Janet Woodcock said it expected the pause to be a matter of days, and it was aimed at providing information to healthcare providers so that they can diagnose, treat and report such blood clots.

FDA official Peter Marks said that part of the reason for the pause was to warn doctors that administering the standard treatments for clots can cause tremendous harm, or be fatal.

‘LESS THAN ONE IN A MILLION’

Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer/BioNTech shots.

U.S. health officials said during a press briefing there had been no similar blood clot cases reported among recipients of the Pfizer/BioNTech of Moderna vaccines.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the FDA will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.

“Even if all of the cases were caused by the vaccine, the risk of less than one in a million would have to be set against the benefits of protection from COVID-19 disease; a disease which, in itself, causes clotting in many cases,” said Peter English, a retired consultant in communicable disease control and a vaccine expert.

‘ABUNDANCE OF CAUTION’

“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.

J&J’s shares were down 2.6% in early New York trade.

The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.

Among leading global COVID-19 vaccine developers, China’s CanSino Biological and Russia’s Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

The rollout of J&J’s vaccine has been slowed by issues at production plants.

The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.

J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.

J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country’s health department. J&J recently struck a deal with the African Union for up to 400 million doses.

Europe’s drugs regulator continues to recommend the use of AstraZeneca’s COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

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Australia has 2nd likely AstraZeneca COVID-19 vaccine clot case

AstraZeneca US chief lauds new vaccine, dismisses blood clot concerns

AZ US President Ruud Dobber tells ‘Your World’ studies showed no significant clotting side effects

CANBERRA, Australia – Australian authorities have identified a second case of a rare blot clot likely linked to the AstraZeneca coronavirus vaccine.

Officials said Tuesday the woman is in her 40s and is in a stable condition. A 44-year-old man developed the same condition following an AstraZeneca injection March 22.

SHOULD PEOPLE VACCINATED AGAINST CORONAVIRUS STILL GET TESTED?

Australia has administered 700,000 doses of the AstraZeneca vaccine since early March. That equates to a clotting frequency of 1-in-350,000 cases. British authorities say the risk of such blood clots has been 1-in-250,000 in that country.

Australia had planned to rely on Australian-manufactured AstraZeneca for delivering at least one dose of a vaccine to all eligible adults among its population of 26 million by October. But it said last week the Pfizer vaccine is now the preferred option for people under 50 because of the potential risk from AstraZeneca.

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