Category: General

The U.S. government on Thursday permanently eased some restrictions on a pill used to terminate early pregnancies, allowing the drug to be sent by mail rather than requiring it to be dispensed in person.

The decision by the Food and Drug Administration comes as the right to obtain an abortion, established in the 1973 Supreme Court ruling Roe v. Wade hangs in the balance.

The medication, generically known as mifepristone, is approved for use up to 10 weeks of pregnancy and is also sometimes prescribed to treat women who are having miscarriages.

“The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients,” said Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union.

The restrictions on the pill had been in place since the FDA approved the drug in 2000 and were lifted temporarily by the government earlier this year because of the pandemic. That enabled women to consult health care providers by telemedicine and receive the pills by mail. The FDA’s decision makes that temporary change permanent.

As a result of the FDA rule change, many patients will not need to go to a clinic, medical office or hospital in person to receive the medication but can opt to receive the pill through the mail from a certified prescriber or pharmacy.

The decision will increase access to medication abortion for women in remote and rural areas without providers nearby.

Low-income women who face obstacles reaching clinics such as lack of transportation and inability to take time off work will also gain greater access to the drug.

However, 19 states including Texas have laws that supersede the FDA decision by barring telehealth consultations or the mailing of abortion pills. Women in those states would not be able to make use of the rule change at home but could potentially travel to other states to obtain medication abortion.

States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states.

The change is likely to add to the intense U.S. political debate over abortion. Conservative Supreme Court justices indicated in December 1 oral arguments over an abortion ban in Mississippi at 15 weeks of pregnancy that they were open to either gutting Roe or overturning it entirely. A decision is due by the end of June.

The Charlotte Lozier Institute and Susan B. Anthony List, which advocate against abortion, said in a statement that the FDA decision ignored data on complications and put women at risk.

The groups called on the FDA to restore the in-person dispensing requirement and add restrictions.

FDA records show that of the 3.7 million women who took Mifeprex, the branded version of the drug, to terminate a pregnancy between September 2000 and December 2018, 24 died from complications.

Some restrictions remain

The FDA left in place some restrictions, such as the need to use a certified pharmacy and requiring the prescribers to be certified. The ACLU said it was “disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone, and these remaining obstacles should also be lifted.”

The organization sued the U.S. government on behalf of a Hawaii doctor and several professional health care associations in 2017, challenging the restrictions that it said limited access to medication abortion.

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.

Source: Voice of America

A panel of outside advisers to the U.S. Centers for Disease Control and Prevention on Thursday voted to recommend that Americans choose one of the other two authorized COVID-19 vaccines over Johnson & Johnson’s shot because of the rare but sometimes fatal cases of blood clotting.

The CDC’s Advisory Committee on Immunization Practices voted unanimously on the recommendation. The regulator still needs to sign off on the guidance.

Cases of thrombosis with thrombocytopenia syndrome (TTS), which involves blood clots accompanied by a low level of platelets, have previously been reported in recipients of the J&J vaccine. The highest reporting rates are in women under 50.

The CDC said that the rate of such incidents is higher than previously estimated in both women and men.

At least nine people have died following the blood clotting incidents in the United States, the CDC has said.

Members of the panel also said J&J’s vaccine is less effective in preventing COVID-19 than the other two authorized vaccines.

In a presentation to the committee, a leading J&J vaccine scientist said the vaccine generates a strong and long-lasting immune response with just a single shot.

“In the setting where many people do not return for a second dose or a booster, the durability of the single-shot Johnson & Johnson vaccine as a primary regimen could make a crucial difference in saving lives in the U.S. and around the globe,” J&J’s Dr. Penny Heaton said in the presentation.

J&J’s vaccine uses a technology based on a modified version of an adenovirus to spur immunity in recipients, while the other two authorized vaccines use messenger RNA technology.

J&J’s one-dose vaccine received emergency use authorization in March. In April, U.S. regulators paused administering the vaccine for 10 days to investigate the blood clotting.

A CDC scientist said on Thursday that the rate of deaths from TTS did not decrease after the pause in April.

Fewer Americans have received the J&J shot than the other two vaccines — by a significant margin. Out of more than 200 million fully vaccinated people in the United States, around 16 million received J&J’s vaccine, according to CDC data.

Source: Voice of America

The White House COVID-19 Response team Wednesday said early data indicates the omicron coronavirus variant is spreading in the U.S., but current vaccine boosters appear to be effective in fighting it.

CDC Director Rochelle Walensky said the variant is in 36 U.S. states and accounts for 3% of all U.S. COVID-19 cases, though it is higher in some areas, such as New York and New Jersey, where it may account for as much 13% of cases.

Walensky said while the vast majority — 96% — of U.S. cases are still caused by the delta variant, she said early data show the omicron variant spreads faster than delta, with cases doubling in about two days.

Walensky, along with White House Chief Medical Adviser Anthony Fauci and COVID-19 Response coordinator Jeff Zients, cited data showing being fully vaccinated along with a booster shot is the best way to fight off the new variant.

“Our booster vaccine regimens work against omicron,” Fauci said. “At this point, there is no need for a variant-specific booster.”

Walensky cited recent data from U.S. nursing homes showing unvaccinated or fully vaccinated residents without boosters were 10 times more likely to contract COVID-19 than residents fully vaccinated with boosters. Fauci cited the most real-world studies showing boosters can increase anti-body protection against omicron by as much as 35 times.

Zients cited CDC statistics showing an unvaccinated person is eight times more likely to be hospitalized and 14 times more likely to die from COVID-19 than a fully vaccinated person. He said a new study from the Yale University of Public Health shows the U.S. vaccination program prevented 10.3 million hospitalizations and saved 1.1 million lives.

The COVID-19 response coordinator said 14 million people received booster shots in the first two weeks of December, with 26 million total shots in arms during the same period. In total, the team reports more than 200 million U.S. residents are now fully vaccinated, and more than 55 million have received booster shots.

Source: Voice of America

The head of the South African Medical Association says there is a major difference between the delta and omicron variants of the coronavirus and warns politicians against hyping the threat from the new strain.

Dr. Angelique Coetzee criticized Tuesday what she described as the “over-reaction” to the heavily mutated omicron variant by some European governments and cited Britain’s Boris Johnson, who she accused of creating “hysteria” about the new strain.

On Tuesday, the House of Commons approved the reimposition of pandemic restrictions, and the introduction of some new ones, because of rising omicron cases in the country, although Johnson faced a major rebellion by a third of his parliamentary party and relied on opposition parties for the vote.

Coetzee was one of the first medical practitioners in the world to raise the alarm about the new variant. Its genomic data was sequenced last month by scientists in Hong Kong, Botswana as well as South Africa. The emergence has contributed to pandemic alarm in Europe, where governments are already battling the delta strain and are racing to reimpose restrictions.

Coetzee told Britain’s Sky News that delta was heart-breaking and that her patients who contracted it were “extremely, extremely sick” and when opening the door to them “you just knew they were in trouble,” she explained.

But nearly a month into the omicron wave in South Africa, she says she has not seen similar grim scenes and that her omicron patients are suffering much milder symptoms. Apart from one, who had HIV and other comorbidities, none have died.

The British government’s medical advisers are predicting one million omicron infections by the end of the month, and although South Africa is seeing tens of thousands of new cases daily.

Coetzee cautions calm, saying Britain and other European countries are much better vaccinated than South Africa and in a better position to battle it. “Even if you get breakthrough infections, it’s mild cases,” she added, saying she understands the need to take precautionary measures but says, “don’t hype it up.”

Some scientists disagree with Coetzee.

The chief executive of Britain’s Health Security Agency told lawmakers Wednesday that omicron “is probably the most significant threat since the start of the pandemic.”

Dr. Jenny Harries said the new variant was much more transmissible than delta and the rapid spread of omicron would lead to a “staggering” number of COVID cases over the next few days. She delivered a series of dire warnings about the country’s health care system, although she added it was probably too early to tell how serious the scale of increasing infections across the world would turn out to be.

“The difficulty is that the growth of this virus, it has a doubling time which is shortening, i.e., it’s doubling faster, growing faster,” she said.

Governments across Europe are closely observing events unfolding in Britain for a sense of what may lie ahead for them as omicron spreads, and they are worried that reinfection rates from omicron are much higher than has been seen with earlier variants.

Restrictions and penalties

More countries are adopting restrictions. Italy this week required negative tests from vaccinated visitors to the country. Portugal has a similar measure in place. Many European countries have a virtual lockdown for the unvaccinated and are scrambling to increase vaccine booster programs. And more governments, including Germany’s, are proposing or considering mandatory vaccines.

Austria and Italy already plan to impose hefty fines on eligible people who do not get vaccinated.

People over 65 years old in France will be under effective lockdown from Wednesday, if they have not received a third vaccine booster dose.

France’s health pass will no longer be valid for the elderly who have not received a third dose, barring those who have not been boosted from visiting restaurants or cafes or taking intercity trains. They will also be prohibited from visiting cultural venues like cinemas or museums.

European Commission President Ursula von der Leyen warned Wednesday the European Union faces a double challenge, with a massive increase of delta cases in recent weeks and the threat of omicron looming. “We’re seeing an increasing number of people falling ill, a greater burden on hospitals and unfortunately, an increase in the number of deaths,” she told European Parliament lawmakers.

“And what I’m concerned about is that we now [are] seeing the new variant omicron on the horizon, which is apparently even more infectious,” she added.

But as governments go into overdrive, some epidemiologists and virologists are echoing Angelique Coetzee. Professor Tim Spector, the head of Genetic Epidemiology at King’s College, London, says the “majority of symptoms are just like a common cold, so we’re talking about headaches, sore throat, runny nose, fatigue, and things like sneezing.” He added: “So, things like fever and cough and loss of smell are now actually in the minority of the symptoms that we’re seeing.”

Earlier this week, the first major study published into the new variant also suggested illness from omicron is less severe than from delta. The study of 78,000 omicron cases in South Africa found the risk of hospitalization is 29% lower compared with the Wuhan strain, and 23% lower than with delta. Far fewer people have been needing intensive care. Just 5% of omicron cases have been admitted to intensive care units compared to 22% of delta patients, the study shows.

The data for the study was compiled by Discovery Health, South Africa’s largest private health insurer, and the South Africa Medical Research Council. It noted omicron can evade vaccines more than earlier strains, but the study found vaccines are still holding up well, although there were high numbers of breakthrough infections in people who had been vaccinated.

Vaccine effectiveness against infection dropped from 80% to 33%, according to the study, but offered 70% protection against hospital admission. Boosters may also mitigate the reduction in vaccine effectiveness, according to the study. Some European scientists have cautioned, though, against reading too much into the South African study, saying that South Africa’s population is much younger and that demographic differences could alter medical outcomes.

Source: Voice of America

U.S. President Joe Biden said Tuesday he is encouraged by data released by Pfizer Inc on its COVID-19 anti-viral medicine and his administration has ordered enough of the pills to treat 10 million Americans.

“Getting vaccinated and getting your booster shot remain the most important tools we have to save lives. But if this treatment is indeed authorized “and once the pills are widely available” it will mark a significant step forward in our path out of the pandemic,” Biden said in a statement.

Source: Voice of America

The disfiguring disease noma, found mainly in poor areas of sub-Saharan Africa that lack health care, kills 90% of victims, most of them children, when left untreated. Noma is preventable, and to that end, aid groups are urging the World Health Organization to add Noma to its list of neglected tropical diseases.

Eight-year-old Amadou Compaore recently recovered from noma, a little-known tropical disease.

Although noma has scarred his face, Compaore, relatively speaking, is one of the lucky ones. If noma is diagnosed within the first few weeks of infection, it is easily treatable with a course of antibiotics.

His father, Sibiri Compaore, told VOA, he noticed the disease in the run-up to Christmas. To begin with, Amadou said his mouth ached to the point where he couldn’t eat anymore. He even had great difficulty drinking sachets of water.

Compaore senior took his son to the nearest city, Kaya, about 25 kilometers away, where medical staff were able to identify the disease thanks to awareness building by the Swiss non-governmental organization Sentinelles.

Sidi Omar Boena is a nurse at a Sentinelles medical center in Ouagadougou, specializing in the treatment of noma.

He says most health workers in Burkina Faso have not heard of the disease noma and that diagnosing it in people 400 to 500 kilometers from Ouagadougou is very difficult.

He says that he is sometimes forced to diagnose noma with photos sent to him via WhatsApp.

Odette Serene, who also suffered from noma, now receives regular follow-up treatment at the Sentinelles clinic, including support in finding a job.

She now works as a tailor, but she says people still laugh at her, which makes her sad. She says Boena has done a lot to take care of her, however.

Noma is just one of many illnesses currently missing from the World Health Organization’s list of neglected tropical diseases.

Doctors Without Borders, a medical NGO, is running a campaign to have noma added to the WHO list, which already includes diseases like rabies and dengue fever.

“Of course, at the community level, there is discrimination affecting the patients, and so every time there is a case, we might not even be aware because patients are hidden by the communities or they are dying. More than 90% of people are estimated to die,” Jeantet said.

The WHO says when it adds diseases to the list, factors like social stigma and death rates are taken into consideration. The WHO says resources are limited, so some diseases have to be left off.

WHO press officer Ashok Moloo explains the effect of adding a disease to the list.

“It really brings the disease or the condition to another level … It also adds to the advocacy part of the disease, awareness creation and also resources,” Moloo points out.

As for Amadou Compaore, he says what the doctors have done to help him has been an inspiration. He told VOA he wants to become a doctor, to treat people so that they can be cured, like him.

The WHO plans to make possible new additions to its neglected tropical disease list in 2023. It remains to be seen if noma will be among them.

Source: Voice of America