The US Is Ending The Really Useful Hiatus In Use

29-04-2021

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U.S. health officials on Friday lifted a recommended hiatus for the use of Johnson & Johnson’s Covid-19 vaccine and provided assistance to state and local authorities in distributing the doses that are considered critical to delivering life-saving shots to hard-to-reach ones To bring communities.

The Centers for Disease Control and Prevention and Food and Drug Administration’s announcement came after the CDC’s Advisory Committee on Immunization Practices known as ACIP, recommended on Friday for further use of the J&J vaccine, explored the benefits of the Shot outweighed risk. The committee is an external body of experts that advises the CDC.

Advisory panel members did not recommend U.S. regulators limit the use of the J&J vaccine by age or gender, but suggested that the Food and Drug Administration consider adding a warning to women under the age of 50.

In a statement late Friday, the FDA and CDC said they were confident the vaccine would be safe and effective in preventing Covid-19, adding that the risk of blood clots was “very low”.

“Safety is our top priority,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement. “This pause was an example of our comprehensive security monitoring designed to work – and identify even this small number of cases.”

“We have taken the hiatus based on a review of all available data by the FDA and CDC and in consultation with medical experts and based on recommendations from the CDC Advisory Committee on Immunization Practices,” said Woodcock. “We have concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh the known and potential risks in those aged 18 and over.”

During a press conference on the announcement, Woodcock said health care providers should review revised FDA datasheets on the vaccine, which include details about rare blood clots. People with questions about the vaccine should discuss these with a health care provider, she said.

J & J’s Covid-19 vaccine, like the Pfizer and Moderna shots, received emergency approval from the FDA to begin distributing the doses in the United States. An EEA grants conditional clearance based on two months of safety data until another submission for full approval, which normally requires at least six months of data.

On April 13, the FDA and CDC urged states to temporarily discontinue use of J & J’s vaccine “out of caution” after it was reported that six women aged 18 to 48 years had a cerebral combination with low platelets Venous sinus thrombosis developed. CVST occurs when a blood clot forms in the venous sinuses of the brain. It can prevent blood from draining from the brain and can eventually lead to bleeding and other brain damage.

Within hours of the warning from U.S. regulators, more than a dozen states, along with some national pharmacies, stopped vaccinating with J & J’s vaccine. Some sites replaced the J&J recordings for scheduled appointments with either the Pfizer or Moderna vaccine.

The US government should lift the recommended hiatus shortly after the committee voted in favor.

Prior to Friday’s vote, the committee debated whether to recommend against J & J’s use of the vaccine or recommend it to U.S. regulators enforcing a warning label. The committee also considered limiting use of the vaccine based on age or other risk factors.

During the meeting, CDC official Dr. Tom Shimabukuro, there have been no reports of the condition of those who received the Pfizer BioNTech mRNA vaccine. There have been three reports of CVST in patients receiving the Moderna vaccine, he said, even though the patients did not have the low platelet levels seen in the J&J recipients.

Platelets help the body form blood clots to heal wounds. US health officials warned against a treatment such as blood-thinning heparin in patients with low platelets, which could make their condition worse.

Rare blood clots with low platelets occur in women aged 18 to 49 at the rate of 7 per 1 million vaccinations for the J&J shot and 0.9 per 1 million in women aged 50 and over. This is evident from a slide presented at the CDC panel meeting. CDC has confirmed a total of 15 cases of rare blood clots, including 12 women who developed blood clots in the brain. According to the presentation, three women died and seven remained in the hospital.

There are no confirmed cases in men, although officials have stated that they are looking at potential additional cases.

Dr. Michael Streiff, a hematologist at Johns Hopkins University Medical School, said the condition is very rare under normal circumstances. “I can tell you from my experience treating these patients that I’ve just never seen it before,” he told the committee during a presentation on Friday.

Earlier this week, J&J announced that it would restart its vaccine rollout in Europe after regulators there backed the single vaccine by recommending adding a warning to the label. The European Medicines Agency has examined all available evidence, including reports from the United States.

MICROCEFALIA – CAUSES, SYMPTOMS AND TREATMENT

25-4-2021

Microcephaly, which has always been a relatively unusual and poorly understood problem in the general population, has recently gained much notoriety due to its association with Zika virus infection during pregnancy.

In this article we will explain what microcephaly is, what are its main causes, its symptoms, the forms of diagnosis and the treatment options.

Here, let’s talk about microcephaly in general, related to several distinct diseases, including Zika. If you are looking for specific information about Zika fever microcephaly, visit the following link: ZIKA FEBRE – Causes, Symptoms, Microcephaly and Treatment.

WHAT IS MICROCEPHALY?
The size of the children’s head is directly related to the size of the brain. If the baby’s brain grows, his skull expands in the same proportion.

Our skull is composed of six bones that at birth are separated by fontanelles (molleiras). This separation allows the skull to expand as the brain grows.

The brain literally pushes the bones of the skull, causing them to expand. This rate of expansion is higher in the first few months and gradually decreases over time as the fontanelles close and limit the capacity of skull expansion.

If for some reason the fetus does not properly develop the brain inside the uterus, it will be born with a smaller sized skull than expected. These cases are called congenital microcephaly.

Microcephaly can also be acquired. A baby may have had normal development in the fetal stage, but the brain may stop growing after birth. Over time, your child’s body will grow faster than your skull, making your head look smaller than expected. These cases that arise after birth are called acquired microcephaly.

Early closure of the fontanelles, called craniosynostosis, is another possible cause of acquired microcephaly. In this case, the brain does not grow because there is a limitation of its physical space.

In most cases, microcephaly is related to a delay in intellectual development. In about 15% of patients, however, microcephaly is mild and the child may have a normal or near-normal intelligence level.

As already mentioned, microcephaly itself is not a disease, it is a sign of disease. When a child has microcephaly, one must try to identify the cause behind this change.

We will speak specifying the causes later.

CRITERIA FOR MICROCEPHALY
The definition of microcephaly used in the introduction of this article is as simple as possible: a head whose circumference is smaller than the circumference expected for children of the same size and age.

In practice, however, we need a somewhat more detailed definition, involving numbers or percentages so that this comparison with the rest of the population can be made.

Historically, the scientific definition of microcephaly has always been somewhat complex and difficult to understand for the lay public. The two most commonly used settings are:

• Occipitofrontal circumference (COF) less than 2 standard deviations below the mean or lower than the 3rd percentile (mild microcephaly).
• Occipitofrontal circumference (COF) less than 3 standard deviations below the mean (severe microcephaly).

To use the above criteria, one must understand the concept of standard deviation and have a table with the circumferential occipitofrontal circumference curves for the various ages, taking into account the characteristics of the population in question.

With the emergence of Zika cases in pregnancies, the incidence of microcephaly increased sharply, and the diagnosis needed to be simplified, at least for newborns.

With a view to facilitating and increasing the detection of cases of microcephaly, the World Health Organization (WHO) has started to recommend microcephaly as a simple measurement with a head circumference measuring tape (skull circumference), as shown in the photo that opens the article.

Boys with cephalic perimeter less than or equal to 31.9 cm or girls with cephalic perimeter less than or equal to 31.5 cm are considered microcephalic.

It is important to emphasize that this criterion only applies to newborn and full-term children, that is, more than 37 weeks of gestation.

This criterion is not useful for the diagnosis of acquired microcephaly or congenital microcephaly in preterm infants.

CAUSES OF MICROCEPHALY
Several diseases can cause microcephaly, from genetic problems, to drugs or drugs during pregnancy, to infections and to trauma.

Below we will list some of the possible causes:

• Disorders of genetic or chromosomal origin, such as Down Syndrome, Poland, Edward, Patau, Rett, X-linked microcephaly and several others.
• Complications during childbirth or during pregnancy leading to lack of oxygen to the baby’s brain (hypoxic encephalopathy).
• Craniosynostosis (early fusion of skull bones).
• Infections during pregnancy, such as rubella, cytomegalovirus, toxoplasmosis, syphilis, varicella, HIV or Zika.
• Meningitis.
• Use of teratogenic medicines during pregnancy.
• Maternal malnutrition.
• Consumption of alcohol in pregnancy.
• Drug use in pregnancy, such as heroin, marijana, or ocaine.
• Smoking during pregnancy.
• Radiation exposure.
• Maternal folate deficiency.
• Maternal metabolic diseases, such as phenylketonuria.
• Maternal poisoning by lead or mercury.
• Diabetes mellitus poorly controlled during pregnancy.
• Stroke in the newborn.

Although the above list is large and not complete, many cases of microcephaly end up being left unidentified. This usually occurs because they are caused by genetic abnormalities whose research is not available at their place of residence, or by inadvertent exposure to harmful substances or by prenatal infections that were not diagnosed during pregnancy.

SYMPTOMS OF MICROCEPHALY
The signal present in all cases of microcephaly is a small head, of a size disproportionate to the body. Microcephaly capable of causing retardation in intellectual development is often quite obvious on physical examination.

Some patients with mild microcephaly do not have any other signs or symptoms other than a head that is less than the average of the population. In these cases, called isolated microcephaly or microcephaly vera, intellectual capacities may be almost or completely preserved.

In most cases, however, microcephaly is accompanied by other signs and symptoms, whether they stem from poor brain development or from the syndromes themselves that have impeded proper growth of the brain and skull.

Depending on the severity of the accompanying syndrome, children with microcephaly may have:

• Late intellectual development.
• Delay in speech development.
• Delay in baby developmental milestones (sit, stand, crawl, walk… )
• Motor incoordination.
• Muscular rigidity (spasticity).
• Imbalance.
• Facial distortions.
• Physical changes typical of the genetic syndrome of which the patient is a carrier (such as Down’s syndrome, for example).
• Short.
• Hyperactivity.
• Convulsive crisis.
• Visual or auditory deficits.

DIAGNOSIS OF MICROCEPHALY
The diagnosis can be made even during pregnancy through fetal ultrasound, which is able to measure the size of the fetal skull. The best time for this evaluation is at the end of the 2nd trimester, during the exam that is usually called “morphological ultrasound”.

Even though fetal ultrasonography is normal, the baby’s head circumference should be measured 24 hours after birth. If you are normal, your pediatrician should keep measurements during routine appointments until the child is two years old and your fontanelles are closed.

If at any time the pediatrician suspects microcephaly, the child should be referred to a specialized pediatrician.

Some imaging tests, such as magnetic resonance imaging, can provide important information about the baby’s brain structure, helping to confirm microcephaly, and give tips on its possible causes.

TREATMENT OF MICROCEPHALY
Although there is no cure, there are treatments that help minimize the problems caused by microcephaly.

As already mentioned, infants with mild microcephaly generally present no other problems than a small head. These cases only need monitoring, and no specific treatment is required.

For babies with craniosynostosis, there are surgeries that help detach the bones from the skulls, allowing the brain to grow without restrictions.

In children with more severe cases, the treatment aims at controlling the associated signs and symptoms, such as muscle stiffness, seizures, delayed speech development, etc.

The neurological prognosis is directly related to the degree of microcephaly, being worse in patients with occipitofrontal circumference below 3 standard deviations below the mean and in those with microcephaly caused by more severe genetic syndromes or infections during pregnancy