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Tuesday, December 29, 2020

Can pregnant women receive the Covid-19 vaccine?

Clinical trials for the Pfizer BioNTech Vaccine did not include either pregnant or lactating women, and the company has said available data is so far "insufficient" to determine any risks to pregnancy posed by the vaccine.

In the UK, this absence of data has led regulators to exclude pregnant and breastfeeding women from vaccination programme. In the US, the decision has been left up to these women themselves.

Here's why the two countries are split, and what that means for pregnant women.

So far, it doesn't say much at all.

"There were no data, period," said Dr Ruth Faden, a bioethicist at Johns Hopkins University, who specialises in the rights and health of pregnant women. There is no suggestion that the jab is especially risky for pregnant and lactating women, there just isn't yet enough information to say.

Pfizer has said it followed the guidance of the US Food and Drug Administration in leaving out pregnant and breastfeeding women from its clinical trials. These women will not be included in clinical trials until the company completes so-called Dart studies (developmental and reproductive toxicity), often conducted in animals.

Experts say this is customary.

"In non-pandemic times, if you are talking about a brand new vaccine, most reasonable people who are committed to advancing the interests of pregnant women and their offspring would still say we should not involve pregnant women" in early clinical trials, Dr Faden said. "You can't put them in right from the beginning".

In bioethics, pregnant women are described as "a complex population", Dr Faden said. "Nowhere else do you have two entities at one time, both of whom are objects of moral concern."

"And by and large, no one cares more about the well-being of the offspring than the pregnant woman. The first question you usually get is 'will this be safe for my baby?'" she said.

But the decision to leave out pregnant women from clinical trials is more complicated in the midst of a pandemic.

"We're in a tough place," said Dr Emily Stinnett Miller, an obstetrician at Northwestern University and a member of the Covid-19 task force of the Society for Maternal and Fetal Medicine. "They're having to make critical decisions quickly, and there are pros and cons to inclusion and exclusion."

A serious con - a lack of data - is evident now. "We don't really have the data to make these clinical decisions that we need to make," Dr Miller said.

Faced with the same lack of data, the UK and US are split in their policy response.

"When you have no data that speaks specifically to the question, then the next question is to step back and say 'OK, what otherwise do we know?'" Dr Faden said.

The UK has taken the more cautious path. On its website, Public Health England said that while the evidence "raises no concerns for safety in pregnancy", the agency "wants to see more non-clinical data" before finalising its advice for pregnancy.

"As specific clinical trials of Covid-19 vaccines in pregnant women have not yet been carried out, there isn't sufficient evidence to recommend the routine use of Covid-19 vaccines to pregnant or breastfeeding women," said Dr Edward Morris, president of the Royal College of Obstetricians and Gynaecologists (RCOG), in a statement.

Experts in the US went another way, leaving the the decision of vaccination to pregnant and breastfeeding women.

"The experts came to a consensus view that scientific plausibility of harm just wasn't there," Dr Faden said. But, she cautioned, "that doesn't mean zero".

The Covid vaccine trials may have happened at breakneck speed, but they haven't skipped any steps, regulators in the US and UK have said, and approval is only given when a vaccine is both safe and effective.

In both countries, pregnant and lactating women will have to wait for more information before getting a clearer recommendation on the vaccine.

Preliminary results from Pfizer's developmental and reproductive toxicity studies are expected by the end of the year. Once these studies are complete, the company may expand its clinical trials to include pregnant women. There are also a handful of women who became pregnant while in the midst of the trial who will be monitored through their pregnancy.

The Royal College of Obstetricians and Gynaecologists has urged the UK government to fund research studies on the vaccine and its suitability for pregnant and breastfeeding women. And data will also be collected from pregnant and breastfeeding women in the US who elect to take the vaccine in the coming months. This will come first from the country's healthcare workers - among the first in the US to be eligible - some 330,000 of whom are estimated to be pregnant or breastfeeding.

"We'll have to keep our fingers crossed that this data...will allow an unambiguous, full-throated recommendation on pregnancy," Dr Faden said.

In the meantime, some pregnant and breastfeeding women say they will avoid the jab.

Joanna Sullivan, 35, who lives in southwest Ohio, is expecting her first baby in June. She does not plan to seek the vaccine until after she gives birth.  "I don't know about any kind of complications, and being my first one, being older, there's already higher risk there," she said. And while it would be "helpful" to see how other pregnant women respond, Mrs Sullivan said she will likely hold off. In Gloucestershire, England, Amy Collender, 34, said she might consider the jab while breastfeeding, but only now that her son is nearly two years old. "If I had a newborn baby, I might not," she said. And if she were still pregnant, she would likely choose to opt-out. And both women said that while they'd like more information, they would not volunteer to participate in a clinical trial themselves. "That's the thing, I understand why there weren't pregnant people doing the trial," Mrs Sullivan said. "Who wants to put their baby at risk?" But according to Dr Faden, successful inoculation against Covid-19 means that pregnant and breastfeeding must be included. "We cannot have an effective vaccine against this pandemic unless we have a vaccine that pregnant women can take, full stop," Dr Faden said.

Thursday, May 14, 2020

What is a novel coronavirus?


What is a novel coronavirus?

â€ĸCoronaviruses (CoV) are a large family of viruses that cause a wide range of illness from the common cold to more severe diseases

â€ĸi.e., Middle East Respiratory Syndrome [MERS] and Severe Acute Respiratory Syndrome [SARS]

â€ĸA novel coronavirus (nCoV) is a new strain that has not been previously identified in humans.

 â€ĸCoronaviruses (CoV) are a large family of viruses that cause a wide range of illness from the common cold to more severe diseases. They are often zoonotic.

â€ĸI.e., Middle East Respiratory Syndrome [MERS] and Severe Acute Respiratory Syndrome [SARS]

â€ĸSeveral known coronaviruses are circulating in animals that have not yet infected humans.

â€ĸOn 31 December 2019, the WHO China Country Office was informed of pneumonia cases of unknown cause in Wuhan City, Hubei Province of China.A novel coronavirus (COVID-19) was isolated and identifiedas the causative virus by Chinese authorities on 7 January.

Ref: WHO website

Wednesday, May 13, 2020

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Tuesday, March 31, 2020

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Monday, March 23, 2020

The Coronavirus (COVID-19): Presently World most Threatened Virus now a days.


The Coronavirus (COVID-19) is an virulent disease occurred by severe acute respiratory syndrome coronavirus2. The outbreak was first identified in Wuhan, Hubei, China, in December 2019, and was recognised as a pandemic by the World Health Organization (WHO) on 11 March 2020. As of 23 March, more than 353,000 cases of COVID-19 have been reported in over 190 countries and territories, resulting in more than 15,400 deaths and more than 100,000 recoveries.

The virus is typically spread from one person to another via respiratory droplets produced during coughing.  Primarily, it spreads when people are in close contact but it may also spread when one touches a contaminated surface and then their eyes, nose or mouth. It is most contagious when people are symptomatic, although spread may be possible before symptoms appear. The time between exposure and symptom onset is typically around five days, but may range from two to fourteen days. Common symptoms include fever, cough, and shortness of breath. Complications may include pneumonia and acute respiratory distress syndrome. There is no vaccine or specific antiviral treatment. Primary treatment is symptomatic and supportive therapy. Recommended preventive measures include hand washing, covering the mouth when coughing, maintaining distance from other people, and monitoring and self-isolation for people who suspect they are infected.

Efforts to prevent the virus spreading include travel restrictions, quarantines, curfews, event postponements and cancellations, and facility closures. These include a quarantine of Hubei, nationwide quarantines in Italy and elsewhere in Europe, curfew measures elsewhere in China and South Korea, various border closures or incoming passenger restrictions, screening at airports and train stations, and travel advisories regarding regions with community transmission. Schools and universities have closed either on a nationwide or local basis in over 124 countries, affecting more than 1.2 billion students.

Symptoms of Coronavirus (COVID-19)

Symptoms of COVID-19 are non-specific and those infected may either be asymptomatic or develop flu-like symptoms such as fever, cough, fatigue, shortness of breath, or muscle pain. In my experience most of the cases COVID19 patient are suffering from fever with up to 1000 C temperature up to 4-5 days of virus infection with cough, fatigue. After five days fever temperature will increase and acute breathing problem will appear. The Centers for Disease Control and Prevention (CDC) lists emergency symptoms including difficulty breathing, persistent chest pain or pressure, sudden confusion, difficulty walking, and bluish face or lips; immediate medical attention is advised if these symptoms are present.
Further development of the disease can lead to severe pneumonia, acute respiratory distress syndrome, sepsis, septic shock and death. Some of those infected may be asymptomatic, returning test results that confirm infection but show no clinical symptoms, so researchers have issued advice that those with close contact to confirmed infected people should be closely monitored and examined to rule out infection.

The usual incubation period (the time between infection and symptom onset) ranges from one to fourteen days; it is most commonly five days. In one case, it may have had an incubation period of 27 days.

How to Transmit this Virus

The primary mode of spread is via respiratory droplets that people blow out or cough.  This is thought to take place when people are in close contact, often during coughing or sneezing. The European Centre for Disease Prevention and Control (ECDC) agree that it seems to increase via these droplets, but "there is not enough plausible information at this time [23 March] to determine how easily and sustainably this virus spreads between people." The strength of the SARS-CoV-2 virus in the air and on various surfaces is believed to be comparable to that of other coronaviruses. A single study of how long SARS-CoV-2 (COVID-19) remains infectious on various surfaces, "show[s] that when the virus is carried by the droplets released when someone coughs or sneezes, it remains viable, or able to still infect people, in aerosols for at least three hours.

"Prevention of this virus" is coming next post.........