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Are the rare blood clots linked to AstraZeneca vaccine?

Recently, reports of thrombosis (blood clotting) and thrombocytopenia (low levels of platelets) following the use of AZ vaccine have emerged in the UK and European countries. The EU regulator, European Medicines Agency (EMA) is investigating at least 44 cases of rare brain clots and at least 14 deaths in approximately 9.2 million vaccinations in 30 European countries

Are the rare blood clots linked to AstraZeneca vaccine scaled

The widespread morbidity and mortality associated with the Covid-19 pandemic expedited global vaccine development programmes. The AstraZeneca (AZ) vaccine or Vaxzevria which was co-invented by the University of Oxford and its spinout company, Vaccitech, was approved for the general population to limit the spread of Covid-19. The AZ vaccine uses a chimpanzee viral vector based on an attenuated version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains DNA of the SARS-CoV-2 virus spike protein. Once an individual is vaccinated, the spike protein is produced which prepares the immune system to mount a response against a future SARS-CoV-2 infection. Of the 17,177 participants (UK = 8,948; Brazil = 6,753; South Africa = 1,476)  included in the clinical trial involving the first use of AZ vaccine, the vaccine efficacy after the first dose was 76% and after the second dose, it was 82%.

Blood Clotting Side Effect

Recently, reports of thrombosis (blood clotting) and thrombocytopenia (low levels of platelets) following the use of AZ vaccine have emerged in the UK and European countries. The EU regulator, European Medicines Agency (EMA) is investigating at least 44 cases of rare brain clots and at least 14 deaths in approximately 9.2 million vaccinations in 30 European countries. This accounts for 4.6 cases developing within a few weeks post-vaccination, for every 1 million AZ vaccinations. The levels seen with the Pfizer vaccine which is more widely used than AZ vaccinations in Europe, is reported to be 0.2 per million following vaccine. Based on John Hopkins, the brain clots normally affect five people per 1 million over a year. Up to and including 29th March 2021, Germany’s regulator has reported 31 cases of unusual thrombosis in 2.7 million people vaccinated with the AZ vaccine, of which 29 were female and 2 were male. 9 of the 31 thrombotic cases have died. Moreover, regulators in Norway reported AZ vaccine to allegedly cause clots in six medical workers among 120,000 vaccinated, of which four have died. According to the UK governing body MHRA, 20.2 million AstraZeneca vaccines have been given as of 31st March 2021, of which 79 cases (51 women and 28 men aged 18–79) of thrombosis and thrombocytopenia have been reported in individuals receiving their first dose of AZ vaccination. Of the 79 cases, 44 had cerebral venous sinus thrombosis (CVST) which is a blood clot that prevents draining of blood from the brain, while 35 had thrombosis in other major veins with thrombocytopenia. 19 people (13 females and 6 males) died of which 14 had CVST and the remaining five died from thrombosis. It is important to note that more females received AZ vaccines compared with males. The risk of acquiring the rare forms of blood clots associated with use of AZ vaccines are four in a million.

The underlying process of why clots happen is not yet fully understood. One plausible explanation is the development of thrombosis and thrombocytopenia, which has been attributed to an immune response, consequently leading to a condition seen in individuals treated with blood thinner/anticoagulant heparin (heparin induced thrombocytopenia).  

However, possible mechanisms may include platelets instead of cells producing Covid-19 spike proteins. The platelets are then attacked by the body’s immune system, leading to a clotting cascade. Another potential cause for the increased number in women of child-bearing is the possible interplay of the body responding to the vaccines and natural changes to hormones cycle. Women generally are at an increased risk of developing thrombotic events during their child-bearing years for various reasons. 

Studies thus far

EMA’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) performed an in-depth review of 62 cases of CVST and 24 cases of splanchnic vein thrombosis (related to abdominal clots) in the EU drug safety database (EduraVigilance). As of 22nd March 2021, 18 cases proved to be fatal. The cases originated from spontaneous reporting systems of the EEA and the UK, where approximately 25 million individuals have received the AZ vaccine. The committee concluded that despite the risk of thrombosis coupled with thrombocytopenia associated with the use of AZ vaccine, the benefits conferred by the vaccination in preventing risk of hospitalisations and mortality greatly outweigh the potential risks. These conclusions have been echoed by the MHRA. Moreover, the incidence rates for thrombotic events in the Danish population which included participants close to 5 million aged 18–99 years were reported to be 1.76 per 1,000. Based on the number of individuals affected by thrombotic events with the use of AZ vaccine, the events are extremely rare and are treatable using non-heparin based anticoagulants, as advised by the Expert Haematology Panel.      

It is important to emphasize that 30% of individuals who have contracted Covid-19 develop thrombocytopenia and are at increased risk of developing clots in different regions of the body, including pulmonary embolism (clots in the lung; 7.8%), deep vein thrombosis (clotting in legs; 11.2%), and strokes (clots in the brain; 1.6%). In light of the evidence discussed, the risk of developing thrombosis and thrombocytopenia are significantly higher with Covid-19 than with the AZ vaccine. However, since the risk of harm is increased in individuals aged 18–29 (see Fig1), the use of alternative vaccines other than AZ is recommended. Also, as a safety precaution, a clinical trial to establish the safety and efficacy of AZ vaccine in children has been halted as a precautionary measure despite the trial going well. However, if individuals in this age group have received their first dose of AZ vaccine, then they should also have the second dose of AZ vaccine. Patients who have an increased risk of developing blood clots or have a lower platelet count, should exercise caution and a clinician should evaluate the benefit to risk profile before administering the vaccine. The side-effects associated with the use of vaccines would only be known once individuals receive both jabs and are followed for a longer time period.


Based on the low incidence of thrombocytopenia and thrombosis in individuals treated with AZ vaccine, it is challenging and arduous to determine the causality and link of thrombotic events to AZ vaccine. It could be misleading to apply complex statistical models due to the limited safety and clinical data available on the full doses of vaccines. There are a plethora of confounding factors including the presence of pre-existing medical conditions that may contaminate or modify the link between the AZ vaccine and blood clots. Future studies involving the use of AZ vaccine and thrombotic events should firstly state whether the individual had pre-existing thrombosis, had been previously infected with Covid-19, and whether they were taking medicines that can cause thrombotic events. 

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

Health

UN World Food Program Lowers Aid in South Sudan

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The United Nations World Food Programme (WFP) recently decreased aid services in South Sudan, a major blow for the Central African country where over two-thirds of the population faces food shortages and hunger. 

“Faced with increasing humanitarian needs and insufficient funding, we have taken the painful step to suspend food assistance to 1.7 million people,” said Adeyinka Badejo-Sanogo, WFP Acting Country Director in South Sudan. Instead of assisting an estimated 6.2 million people in the country, the WFP will now only provide aid for 4.5 million. 

Large floods over the last three years have destroyed farms and homes across South Sudan, displacing hundreds of thousands of people. This year, UN officials anticipate more flooding, which will put around 600,000 people at risk of displacement. Violence in South Sudan has similarly forced many people to leave their homes, placing them in vulnerable situations. According to Ms. Badejo-Sanogo, “So far this year, we have seen 200,000 people newly displaced as a result of conflicts.”

South Sudan’s people are in a dire situation, and the international community must make greater efforts to send humanitarian aid to the country. Unfortunately, the Russia-Ukraine War has already diverted many countries’ focus, and nations are struggling with their own economic problems.

But ultimately, even if aid to South Sudan can be increased, it is only a temporary solution. Developing the infrastructure to combat flooding and quelling violence in the nation will create more sustainable long-term solutions.

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

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Health

The End of Roe v. Wade Has Dangerous Consequences for Women’s Health

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When the Supreme Court overturned Roe v. Wade, they did not just steal bodily autonomy from women, but also their future health. By overturning Roe, the Supreme Court has now put pressure on physicians prescribing life saving medications to women.

Abortion has now been banned in six states, and that number is likely to rise swiftly to 16 states. Twelve states have passed trigger laws. Some states have not completely banned abortions, however they have implemented gestational age limits on abortions. While other states have not decided whether or not to ban abortions, the courts and lawmakers will be deciding the fate of women. Only 20 states have abortion protections in place.

These new bans have also brought into question the future of birth control. Will states begin restricting or even outlawing birth control? Although Republicans have dismissed concerns about banning birth control, Democrats have been warning that it is a distinct possibility. Indeed, after Missouri’s strict new ban on abortion went into effect, one major hospital system in Kansas briefly stopped providing emergency birth control, even to victims of rape. 

But the potential healthcare ramifications of these laws do not end there. Many drugs cause birth defects in pregnant women, which raises the question: If women cannot legally terminate a pregnancy, can these drugs legally be prescribed to women of child-bearing ages in states with abortion bans?

“I believe that prescribing is going to become much more defensive and conservative,” rheumatologist Mehret Talabi told Medscape. “Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Teratogens are medications which can cause birth defects. Many teratogenic medications include treatments for acne, cancer, rheumatoid arthritis and psoriasis.

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” Talabi said. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies.” “

Other physicians also shared their fears that doctors would now be wary of prescribing many medications, some of those with little data on pregnancy. 

Dr. Megan Clowse, a Duke University rheumatologist who works with women who are or wish to become pregnant, told Medcape: “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects..”

Dr. Clowse noted that many drugs commonly prescribed to patients with rheumatic diseases, including methotrexate, mycophenolate and cyclophosphamide, are linked to birth defects and loss of pregnancy.. 

“I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure,” she said.

One of these drugs, methotrexate, is an effective cancer treatment and many rheumatic conditions, but has also been used to cause abortions. “If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it,” Dr. Talabi said.

Mayo Clinic gastroenterologist Dr. Sunanda Kane told Medscape she feared that several of the teratogenic medications used in her field to treat viral hepatitis, constipation and inflammatory bowel disease, would now be affected. While she said doctors in her field generally only prescribe medications with high teratogenic potential to women of childbearing age when they use multiple forms of birth control to prevent pregnancy, she noted that doctors may be less likely to prescribe such drugs if abortion is not available as a legal option. 

“The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk,” Dr. Clowse added. “For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

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Daily Brief

Children Under 5 to get Covid-19 Vaccine by Next Week

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A child gets the Pfizer–BioNTech COVID 19 vaccine
  • The FDA’s outside vaccine advisers finally approved Moderna’s two-shot vaccine for children under age 5. The panel is also set to vote on whether Pfizer’s three-shot series is suitable and safe for this age group.
  • This is the last remaining group in the US to get vaccinated and many outside experts agree that the benefits of Moderna’s COVID-19 vaccine outweigh the risks for children under 5.  If all the regulatory steps are cleared, vaccines can be available by next week.
  • Dr. Joy Portnoy of Children’s Hospital in Kansas City, MO, also a  panel member, stated “there are so many parents who are absolutely desperate to get this vaccine and I think we owe it to them to give them a choice to have the vaccine if they want to.”
  • FDA reviewers stated that both brands appear to be effective and safe for children as young as 6 months, and the most common side effects, which are fever and fatigue, appear to be less common than seen in adults. 
  • Although the two vaccines use the same technology, the shots have not been tested against one another.
  • Once the FDA approves the shots, the CDC will decide on a formal recommendation. Pfizer’s vaccine will be available to children 6 months to 4 years, while Moderna’s vaccine will be for 6 months to 5 years. 
  • Pfizer’s shots are 1/10 of the adult dose, while Moderna’s shots are ¼ of the adult dose. 
  • Moderna is also seeking regulatory approval outside the US for younger children as well. 12 countries already vaccinate children under 5 with other brands.

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

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Society

Monkeypox could be sexually transmitted disease – WHO

Monkeypox virus is caused by skin to skin contact and may be a sexually transmitted disease, warns the World Health Organisation.

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The World Health Organisation (WHO) has started its research on the reports that the monkeypox virus is present in the semen of patients. 

This presents a possibility that monkeypox could be sexually transmitted from one patient to their partners.

It is reported that most cases are in men who have sexual relations with men. 

The WHO has said that the main transmission of the rare disease is through close interpersonal contact.

In Italy and Germany, scientists say that they have detected viral DNA in semen for a small number of monkeypox patients. The virus found in the semen was capable of infecting another person. 

The WHO monkeypox incident manager in Europe, Catherine Smallwood said during a press briefing “this may have been something that we were unaware of in this disease before.”

“We really need to focus on the most frequent mode of transmission and we clearly see that to be associated with skin to skin contact,” she added.

The monkeypox outbreak is now considered a global outbreak. In more than 30 countries there have been more than 1,600 with over 500 cases in the UK. 

A vaccine of monkeypox is available and the WHO has recommended that close contacts and healthcare workers should be vaccinated first. 

WHO’s regional director for Europe, Hans Kluge said “Europe remains the epicentre of this escalating outbreak, with 25 countries reporting more than 1,500 cases, or 85% of the global total.”

Regarding the race to stockpile vaccines, he added “once again, a ‘me first’ approach could lead to damaging consequences down the road.”

“I beseech governments to tackle monkeypox without repeating the mistakes of the pandemic – and keeping equity at the heart of all we do.”

In the current outbreak, so far no deaths have been reported. But experts warn that every year monkeypox causes deaths in some countries, where the disease exists as endemic. 

The WHO is also considering changing the name of the Monkeypox virus. Consideration came after 30 scientists wrote letters to the WHO that it is not correct but rather discriminatory to give the name of the rare disease as African. 

Some of the Scientists has suggested hMPXV as new name of the virus to address the “urgent need” for a “non-discriminatory and non-stigmatising” name for the virus.

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

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Health

Monkeypox: Something To Be ‘Concerned About’ Says Biden

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On Sunday, President Joe Biden, in his first public comments on the disease, said that recent cases of monkeypox that have been identified in Europe and the United States were something “to be concerned about. It is a concern in that if it were to spread it would be consequential.”

During the President’s first trip to Asia he was asked about the disease as he spoke to reporters at Osan Air Base in South Korea – “They haven’t told me the level of exposure yet but it is something that everybody should be concerned about,” Biden said. As for the vaccine, Jake Sullivan, Biden’s national security adviser, told reporters that the United States has a supply of “vaccine that is relevant to treating monkeypox. We have vaccines available to be deployed for that purpose,” he said. 

Monkeypox is a virus that originates in wild animals like rodents and primates, and occasionally jumps to people. Most human cases have been in central and west Africa, where the disease is endemic. 

According to CDC’s website, Centers for Disease Control and Prevention, Monkeypox was first discovered in 1958 when two outbreaks of a pox-like disease occurred in colonies of monkeys kept for research, hence the name ‘monkeypox.’ The first human case of monkeypox was recorded in 1970 in the Democratic Republic of Congo during a period of intensified effort to eliminate smallpox. Since then monkeypox has been reported in humans in other central and western African countries.

A detailed investigation of the outbreak in Europe, including determining who the first patients were, is now critical, says Shabir Mahdi, a professor of vaccinology at the University of Witwatersrand in Johannesburg.

“We need to really understand how this first started and why the virus is now gaining traction. In Africa, there have been very controlled and infrequent outbreaks of monkeypox. If that’s now changing, we really need to understand why.”

WHO reports about 3,000 monkeypox cases a year in Nigeria. Oyewale Tomori, a virologist who formerly headed the Nigerian Academy of Science, said that outbreaks are usually in rural areas when people have close contact with infected rats and squirrels.

Monkeypox typically causes fever, chills, rash and lesions on the face or genitals. Luckily, to date, no one has died in the outbreak. The estimation by WHO suggests that the disease is fatal for up to one in 10 people. The infection typically lasts two to four weeks and usually clears up on its own.

Britain’s Health Security Agency reported 11 new monkeypox cases on Friday, saying “a notable proportion” of the infections in the U.K. and Europe have been in young men with no history of travel to Africa and who were gay, bisexual or had sex with men.

Dr Susan Hopkins, the Chief Medical Adviser for the U.K.’s Health Security Agency stated that “the evidence suggests that there may be transmission of the monkeypox virus in the community, spread by close contact. We are particularly urging men who are gay and bisexual to be aware of any unusual rashes or lesions and to contact a sexual health service without delay.”

Monkeypox spreads when someone comes into close contact with another person, animal or material infected with the virus. The virus can enter the body through broken skin, the respiratory tract or through the eyes, nose and mouth. Monkeypox is not generally considered a sexually transmitted disease, though it can be passed on during sex. Health authorities stress that we are not on the brink of a serious outbreak and the risks to the general public remain very low.

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

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Health

Oklahoma’s Anti-Abortion Bill: The Newest Development in the United States’ Abortion Controversy

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This Thursday, Oklahoma legislators passed what many have deemed as the most restrictive bill banning abortions in the U.S. The bill prohibits all abortions, except those that are required to save the mother’s life or are the result of rape/incest. The draft law is likely to be ratified by the state governor, Kevin Stitt, and further limit abortion access in the state.

Oklahoma’s measure has garnered national attention for a multitude of reasons. For one, the bill bans abortions immediately after fertilization; this is in stark contrast to pro-abortion laws across the U.S., which permit abortions up to 24 weeks of pregnancy. In September 2021, Texas passed a similarly restrictive abortion law, but even that measure enables abortions up to six weeks of pregnancy. Moreover, the Oklahoma measure comes right after the recent Supreme Court leak draft, which shows that the majority of the court is in favor of overturning the landmark Roe v. Wade ruling. If Roe v. Wade is overturned — which could happen as soon as late June or early July — many U.S. states (including Oklahoma) stand poised to immediately prohibit access to abortions. 
Oklahoma’s bill, along with the SCOTUS leak, highlights how abortion rights in the U.S. are contingent upon the 1973 Roe v. Wade ruling and subject to change suddenly. Indeed, the recent discussions surrounding abortion shed light on the American judicial system and how volatile landmark rulings can be. Looking ahead, Americans must see whether or not the Supreme Court overturns Roe v. Wade. If so, abortion laws across the country will change drastically, and Americans will have to familiarize themselves with dozens of new laws and restrictions. If not, the legal systems of the U.S. will have been examined and questioned nonetheless.

All views expressed in this editorial are solely that of the author, and are not expressed on behalf of The Analyst, its affiliates, or staff.

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