Day: December 16, 2021

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 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