FDA

FDA considers lifting ban on blood donations from gay and bisexual men

On Jan. 27, the FDA proposed easing restrictions for blood donations from gay and bisexual men. Photo courtesy of the Manchester City Library via Flickr.

By Sarah Grinnell ’26

Staff Writer

LGBTQ+ activists had reason to celebrate on Friday, Jan. 27, as the Food and Drug Administration initiated a proposal to change long-standing restrictions on gay and bisexual men’s blood donation, Smithsonian reported. According to an NBC News Article, this ban, which was first implemented during the AIDS crisis in the 1980s, prohibited any man who had had sex with at least one other man within three months of donation from giving blood.

The current draft of the proposal consists of what the New York Post describes as “gender-inclusive, individual risk-based questions,” which would make qualifications for donation dependent on sexual activity rather than orientation. This would measure the risk of HIV transmission equally against all identities, instead of targeting a single group or gender. As Smithsonian explained, in 1985 the FDA indefinitely banned any man who had sex with another man since 1977 from donating blood. The updated guidelines would mean anyone of any gender who has had only one sexual partner in the past three months is eligible to donate blood. 

According to Smithsonian, the FDA has said if the potential donors have engaged in anal sex, had a new sexual partner, or had more than one sexual partner within the last three months, they would be subject to questioning about their recent sexual activity and instructed to wait another three months before donating. The New York Post reported that these new guidelines are based on sexual practice, meaning that women will be impacted by donor restrictions for the first time. According to the New York Post, those in monogamous relationships will be eligible to donate blood regardless of sexual affiliation or gender. 

According to NBC, bans will remain in effect for people who have tested positive for HIV and take medication to treat it. Additionally, those taking oral medications to prevent infection, such as PrEP, must abide by a three month “deferral period” before they can donate, and those taking injectable PrEP would have to wait two years after their most recent injection before being permitted to give blood, Smithsoniam detailed. PrEP, which stands for pre-exposure prophylaxis, is a pill which prevents HIV from settling into the body before it can spread and is typically taken before sex or under other circumstances where infection could be likely, WebMD says.

The proposed guidelines have developed in part due to the drop-off in the number of blood donations seen at the onset of the COVID-19 pandemic, Smithsonian said. With eased restrictions, the number of donors contributing to the national blood supply could increase significantly. During the COVID-19 pandemic, many blood centers have not had enough blood to last even two days, and one fifth of all blood centers have had a one day supply or less, Smithsonian explained. The new proposal hopes to amend this situation. A report from the Williams Institute at UCLA School of Law found that lifts on donor bans for men who have sex with men would increase the annual blood supply by two to four percent.

Tony Morrison, a spokesperson for the LGBTQ+ advocacy group GLAAD, has commented on this development in an NPR report, saying, “[t]hese changes are 40-plus years in the making, and they’re a tremendous leap forward in elevating science over stigma.” 

However, for some, the guidelines still leave something to be desired — especially where the restrictions around PrEP are concerned. As Jose Abrigo, HIV project director for the advocacy group Lambda Legal points out in an AP News article, “[w]e must be conscious to not further stigmatize these safe sex practices and uplift individuals taking precautions.” Claudia Cohn, chief medical officer for the nonprofit Association for the Advancement of Blood and Biotherapies, echoed this statement in a Washington Post article, saying, “keeping the blood supply safe is paramount, but it is also important to move forward so that we are not excluding a group of donors who could be perfectly safe.” 

According to the New York Post, the responses to the proposal have been overwhelmingly positive, with many eagerly anticipating the fruition of FDA Commissioner Robert M. Califf’s promise to “use the best science [to maintain] a safe and adequate supply of blood and blood products in the U.S.,” while preventing further discrimination against any “gender or sexual orientation.”

Medicated abortions become most preferred method of pregnancy termination

Medicated abortions become most preferred method of pregnancy termination

Medicated abortions now account for over half of all abortions in the United States, according to a Feb. 24 policy analysis by the Guttmacher Institute. Preliminary findings indicate that the combination of the pills mifepristone and misoprostol, which work together to induce an abortion, accounted for 54 percent of abortions in the United States in 2020, a significant jump from 39 percent in 2017. Although data collection for 2022 has not been completed, usage is predicted to remain above the 50 percent mark. Various factors contribute to the increase of use, including the COVID-19 pandemic which encouraged remote access to healthcare and increased access to medication instead of in-clinic abortions.

Coming back to college: what you need to know about the delta variant


While students settle back into campus life, the delta variant is an increasingly large threat. Currently, the delta variant is the predominant cause of COVID-19 cases rising in the United States. According to an article published online by Yale Medicine, The delta variant is a highly contagious strain of the SARS-CoV-2 virus. It was first identified in India in December 2020. It rapidly spread and dominated the virus cases of India and the United Kingdom before arriving in the U.S. in March.

CDC and FDA recommend J&J vaccine pause

CDC and FDA recommend J&J vaccine pause

The Centers for Disease Control and Prevention and the Food and Drug Administration recommended pausing the use of the Johnson & Johnson vaccine on Tuesday as they review six reported cases of blood clots forming in individuals days after they received the vaccine.

Pharmaceutical Companies Release Coronavirus Vaccine Updates

By Lily Cao ’21

Staff Writer

As COVID-19 levels spike across the globe, many places around the world are heading into another round of lockdowns. Along with this growing second wave come announcements from companies working on possible coronavirus vaccinations. 

On Nov. 9, American pharmaceutical corporation Pfizer Inc. and German biotechnology company BioNTech SE shared that their mRNA-based vaccine candidate, BNT162b2, has shown record-breaking early results with over 90 percent efficacy against COVID-19. This finding from Phase 3 of their clinical trial was the first interim efficacy analysis, which tests the vaccine’s effectiveness under ideal circumstances. The vaccine was given in two doses with results collected seven days after the second dose. Even though it is unclear how strong the elicited immune response is and how long it will last in human bodies, this achievement marks a milestone in the vaccine development process and provides hope for the days ahead.

Pfizer and BioNTech SE launched the Phase 3 clinical trial of their vaccine candidate on July 27. As of Nov. 9, they have enrolled 43,538 participants worldwide. This is also the first American trial to have permission to enroll children as young as age 12. On Nov. 8, 94 trial participants had tested positive for COVID-19, enough to allow for the first analysis on all cases.

According to its Nov. 9 press release, Pfizer plans to present a submission for Emergency Use Authorization to the FDA in the third week of November. The FDA requires the safety and manufacturing data of the vaccine to obtain approval. Meanwhile, in order to ensure the safety and long-term protection conferred by the experimental vaccine, clinical trial participants will be monitored for an additional two years after receiving the second dose.

One of the challenges the companies face is the widespread distribution of the vaccine once it is approved. The vaccine requires that the single-stranded mRNA be kept below -80 C to preserve the structural integrity of the genetic material. Consequently, the transportation of the vaccine requires special storage boxes and precise techniques.

Similar to Pfizer and BioNTech SE, Moderna Inc.’s vaccine candidate also uses mRNA technology, and recent results from its trial indicate an efficacy of over 94 percent. Moderna’s vaccine, however, does not require storage at temperatures of -80 C and can be preserved at about -20 C, giving it a slight advantage. At the same time, there are currently 17 vaccine candidates that have entered the Phase 2 safety trials, and 12 have begun Phase 3 trials for large-scale efficacy tests.

If Pfizer and BioNTech SE’s vaccine candidate is approved, the companies expect to manufacture globally up to 50 million doses in 2020 and up to 1.3 billion doses in 2021.

Effects of a government shut- down on the FDA and the EPA

BY THEA BURKE ’20

The U.S. government shutdown had many clear implications for various federal departments, employees and policies. Even though the shutdown may have posed a potentially insignificant risk to public health, it is important to understand which agencies do not function at full capacity when the government is closed.

Cosmetics are full of unlabeled dangerous toxins

Cosmetics are full of unlabeled dangerous toxins

BY TESS REMICK ’21

While many college students rush to get ready in the morning, chances are the ingredients in their cosmetic products are the last thing on their minds — they’re concerned about putting it on their faces and making it to class on time. Paying attention to ingredient lists may seem like an unnecessary and tedious task, but ignoring it could have repercussions. Earlier this month, CNN reported that animal waste was one of the many toxins found in counterfeit makeup, or makeup produced to imitate brand name products.