San Francisco has become the first US public health authority to issue formal guidance recommending the strategy following the release of two studies showing doxycycline can slash transmission rates for the potentially life-threatening disease.

In July, a US study found that taking a single dose of doxycycline within 72 hours of having sex without using a condom reduced the risk of contracting syphilis, chlamydia and gonorrhoea by more than 60 per cent among people at high risk of contracting sexually transmitted infections.

But the strategy has raised concerns among some experts, who argue prescribing doxycycline to prevent bacterial STIs could boost resistance to an antibiotic that is also used to prevent malaria and treat other types of infections.

Annie Luetkemeyer, director of medicine and infectious diseases at the University of California San Francisco and a principal investigator on the study, said more surveillance data from communities where doxycycline was being prescribed was required to determine if the strategy would increase antibiotic resistance.

“We are revaluating the impact . . . on bystander bacteria like Staph aureus, commensal Neisseria (found in the throat) and the bacteria in the gut,” she said.

The CDC said it was “excited” by the initial findings of the UCSF study, which was funded by the National Institutes for Health. But Leandro Mena, director of the CDC division of STD prevention, said the agency wanted to review the full data and consider the issue of anti-microbial resistance before issuing formal guidance to doctors.

Mena said the agency was also encouraged by a recent study which suggested a vaccine targeting meningitis had shown promise in reducing the risk of gonorrhoea infections by as much as 40 per cent. Even a partially effective vaccine could have a significant effect in reducing rates of transmission, he said.

“If we could have a vaccine that could effectively reduce the risk of getting these infections. You know that would be the Holy Grail,” Mena added.

This story originally appeared on: Financial Times - Author:Caitlin Gilbert

Two US Food and Drug Administration advisory committees will in November consider an application by HRA Pharma, a subsidiary of Perrigo Company, to sell a previously prescription-only oral contraceptive pill over-the-counter.

It is the first such application to be considered by the agency, which is also in talks with another company, Cadence Health, over its plan to sell contraceptive pills in the same manner.

Cynthia Harper, professor of reproductive sciences at University of California, San Francisco, said over-the-counter access would benefit people who did not have regular access to healthcare providers, such as adolescents, the uninsured and rural dwellers.

Medical experts say there can be negative side effects with birth control pills, such as bleeding between periods and headaches, but these do not impact everyone and usually go away after a few months. Serious problems are rare but some groups — including people who smoke or have had certain types of cancers or blood disorders — are advised to avoid some birth control pills.

Advocates for moving to over-the-counter sales say proper labelling can inform consumers about potential risks. In the UK a brief consultation with a pharmacist is required before selling contraceptive pills.

HRA said its pill is safe for most women to use and has undergone lengthy trials as part of a seven-year pre-application process for over-the-counter access. HRA’s pill, branded Opill, is a “mini pill” that contains progestin, a man-made form of the hormone progesterone that prevents pregnancy.

Cadence plans to ask the FDA to approve a combination pill, which includes progestin and a second hormone, oestrogen.

“The pill has been on the market for 60 years, women know how to use it, they know that it’s basically safe to use. So it makes sense that the pill is also offered as a choice to be available over the counter without prescription,” said Frédérique Welgryn, HRA’s chief strategic operations and innovation officer.

HRA launched a similar over-the-counter pill in the UK last year, which it priced at about £10 per month. No price has been set yet for the US market but it would be affordable, said Welgryn, adding that she expected an FDA decision early next year.

Welgryn said overturning Roe vs Wade meant expanding access to contraception is “more important than ever” in the US. “People really need the full range of reproductive healthcare to plan their lives and futures. So they need contraception, they need emergency contraception . . . and they may need abortion at some point,” she said.

This story originally appeared on: Financial Times - Author:Caitlin Gilbert

The Joe Biden administration is using the bivalent boosters, which contain the original Covid-19 strain and the genetic code of the Omicron sub-variants BA.4 and BA.5, to vaccinate more Americans against the virus.

It has bought 171mn doses of the BioNTech/Pfizer and Moderna boosters for $5bn and fast-tracked their authorisation before human trials are complete, hoping that they provide better protection against the dominant variants than existing Covid vaccines.

Last month, the UK became the first country to approve a bivalent booster. But it waited for clinical data to greenlight a shot targeting the original Covid strain and the BA.1 sub-variant, which has since been superseded by BA.4/BA.5.

On Monday, Pfizer and BioNTech said the European Medicines Agency had recommended the BA.4/BA.5 bivalent booster for conditional marketing authorisation based on data from the companies’ bivalent jab targeting BA.1 and pre-clinical data.

Some scientists agree, noting that new clinical data are not always required when the influenza jab is tweaked annually to target the latest strains.

Nancy Jecker, professor at University of Washington School of Medicine, said the risk of approving the boosters was minimal given they are not significantly different to the original Covid jabs.

“Emergency authorising Moderna and Pfizer boosters based on animal studies gives people the chance to minimise their risk of Covid as more people congregate indoors during fall and winter months,” said Jecker.

But Topol and Offit argued the US should have waited for evidence the boosters are better than the existing jabs.

“I don’t think they have proven that this influenza vaccine strategy — where we pick influenza strains every March for a vaccine that comes out in September — makes sense for Covid,” said Offit.

He said there is no evidence showing the BA.4/BA.5 booster provided better protection than existing jabs. Initial clinical data for the BA.1 bivalent booster showed it produced virus-fighting antibody levels that were 1.5 to 1.75 times higher than the existing jab, which was not a clinically significant difference, Offit said.

The CDC cites polling which suggests 72 per cent of respondents would definitely or probably receive bivalent boosters. If uptake of the jabs reach similar levels to the annual flu vaccine — half of US adults — by early autumn CDC modelling predicts it would prevent 100,000 hospitalisations, save 9,000 lives and billions of dollars in healthcare costs.

To boost uptake the CDC has simplified its guidance on eligibility, recommending a single bivalent booster for everyone over 12 years of age who has already received a Covid vaccine.

But workers on the frontline of the inoculation drive are sceptical the public will rush to get another jab.

“I think demand will continue to be sporadic because those people who want to be vaccinated have already got the vaccine and been boosted,” said Rene Rodriguez, owner of Tens Pharmacy in Roseland, a small town in New Jersey.

“There are really two types of people: those who believe in the vaccine, who are generally up to date with their jabs, and those that don’t.”

This story originally appeared on: Financial Times - Author:Caitlin Gilbert