A trial of an experimental HIV vaccine in Uganda, Tanzania and South Africa has been stopped early after preliminary data suggested it would not be effective in preventing infection, according to the trial's chief investigator.
The news is the latest blow to efforts to find an effective vaccine against a virus that has so far claimed about 40 million lives globally. Another 39 million are living with HIV, the majority of them in Africa.
The trial for the vaccine, part of a wider initiative called PrEPVacc, began in December 2020 with the enrolment of 1,512 healthy adults aged 18-40 and was due to end in 2024.
Pontiano Kaleebu, chief investigator for the programme, told Reuters on Thursday the programme's independent data and safety monitoring committee had "recommended that even if we continue we will not be able to show that the vaccine can be effective".
While there are drugs that can reduce the risk of getting HIV and treatments that can control the virus and prevent people from developing AIDS, the deadly immune condition resulting from untreated HIV, experts say an HIV vaccine would be an important tool in ending AIDS as a public health threat.
The trial, led by African researchers with support from various European institutions like Imperial College London, was testing two different combinations of experimental HIV vaccines.
It was also testing a new form of oral pre-exposure prophylaxis (PrEP), a drug that reduces the risk of getting HIV, to see if it was as effective as existing drugs. That part of the trial is ongoing.
Participants were mostly drawn from populations at high risk of infection like sex workers, gay men and fishermen.
A statement released on Wednesday by the vaccine trial programme said the failed trial, which was the only remaining active HIV vaccine efficacy trial in the world, underscored "how challenging it is to develop an effective HIV vaccine".
Researchers in South Africa terminated another trial in 2020 after tests of a vaccine in more than 5,000 people failed to show benefits.
Former Prime MinisterBoris Johnsontold Britain's COVID inquiry on Thursday that any suggestion he wanted to allow the virus to "let rip" was "rubbish" and "completely wrong".
Johnson, prime minister between 2019 and 2022, faced a second day of questioning which examined the weeks before the country's second national lockdown in November 2020.
Asked whether he had wanted to allow the virus to "let rip", and about suggestions that he believed older people had reached their time, Johnson said: "No, no, no, this is all rubbish".
The inquiry has heard evidence from former advisers that Johnson, fearing the impact on the economy, had once replied "let the bodies pile high" as he wanted to let the virus spread rather than order another lockdown.
He dismissed that evidence as "accounts...culled from people's jottings" and said Britain went into a second lockdown as soon as the disease picked up again.
"The implication that you're trying to draw from those conversations is completely wrong," he said. "My position was that we had to save human life at all ages and that was the objective of the strategy, and by the way, that is what we did."
Coronavirus killed more than 230,000 people in Britain and infected many millions more.
Johnson resigned in disgrace after a series of scandals including reports that he, and other officials, engaged in alcohol-fuelled gatherings in Downing Street in 2020 and 2021, when most Britons had to stay at home.
Asked about what has become known as the "partygate" scandal, he said there had been some mischaracterisation of events at No.10, but added that he was sorry.
"I apologise for the offence that has been caused and if I had my time again of course I'd have done things differently," he said.
The inquiry has heard damaging testimony about a toxic culture in Downing Street during the pandemic, Johnson's reluctance to lock down, and how he was confused by the science of the virus.
In autumn 2020, he said the phrase "let it rip" was in common parlance.
His job, he said, was to challenge the consensus in meetings and ask questions of scientists recommending a full lockdown instead of a policy of shielding vulnerable people and allowing the virus to "rip" among the rest of the population.
"It does not do justice to what we did, our thoughts, our feelings, my thoughts, my feelings, to say that we were remotely reconciled to fatalities across the country or that I believed that it was acceptable to let it rip," he said.
On Wednesday, he apologised at the inquiry for his handling of the crisis, saying his government had initially been too complacent and "vastly underestimated" the risks.
The Biden Administration on Thursday announced it is setting new policy that will allow it to seize patents for medicines developed with government funding if it believes their prices are too high.
The policy creates a roadmap for the government's so-called march-in rights, which have never been used before. They would allow the government to grant additional licenses to third parties for products developed using federal funds if the original patent holder does not make them available to the public on reasonable terms.
Under the draft roadmap, seen by Reuters, the government will consider factors including whether only a narrow set of patients can afford the drug, and whether drugmakers are exploiting a health or safety issue by hiking prices.
"We'll make it clear that when drug companies won't sell taxpayer funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less," White House adviser Lael Brainard said on a press call.
The U.S. government has previously resisted calls to seize the patents of costly drugs, declining in March to force Pfizer and Astellas Pharma to lower the price of their prostate cancer drug Xtandi.
The government will give the public 60 days to comment on the new proposal before attempting to finalize it.
Vanderbilt University professor Stacie Dusetzina said the new policy could discourage investment in the industry if the government ever exercised march-in rights, but might be "useful to have a credible threat if the industry is being completely unreasonable."
Megan Van Etten, a spokesperson for the leading pharmaceutical industry lobby group PhRMA, said allowing the government to use march-in rights based on price would stunt innovation and harm patients.
“The Administration is sending us back to a time when government research sat on a shelf, not benefiting anyone,” she said.
March-in rights were introduced as a safeguard in the Bayh-Dole Act of 1980, which allows the inventors to retain ownership of inventions or products developed with public funds and hold patents.
Under Bayh-Dole, the National Institutes of Health (NIH) has the power to seize patents of federally-funded medicines, but the agency's former director Francis Collins said it did not have the authority to use march-in rights to lower drug prices.
In her first briefing with reporters on Wednesday, recently confirmed NIH Director Monica Bertagnolli said she shared concerns over high drug prices.
"What I will affirm over and over is that I will use every tool I possibly can with the goal of obtaining the access that our patients need. March-in, if I am to ever apply that, it will be according to principles that allow it to really achieve that specific aim."
Progressive lawmakers in the Democratic Party have this year heaped criticism on drugmakers that developed therapies with government funding, and called on President Joe Biden's administration to use its march-in authority to lower drug prices.
In March, Moderna CEO Stephane Bancel was called to testify in Congress after the company flagged plans to raise the price of its COVID-19 vaccine to as much as $130 per dose, drawing the ire of Democratic U.S. Senator Bernie Sanders. The U.S. vaccine maker's Spikevax shot was developed with the help of government funding.
Joseph Allen, who had been a staffer for Senator Birch Bayh and is now director of The Bayh-Dole Coalition, a group that works to educate on the law, said Congress could challenge the new policy if found to be incompatible with the law.
The Biden administration is considering getting behind new restrictions on who can seek asylum and an expanded deportation process to secure new aid for Ukraine and Israel in a supplemental funding bill, a source familiar with discussions said.
The White House and U.S. Congress are racing to strike a deal that would deliver military aid to the two allied nations while discouraging illegal immigration across the U.S.-Mexico border with only a week until lawmakers depart for a Christmas break.
Republicans have refused to approve more Ukraine funding without additional measures to reduce the record number of migrants attempting to cross the U.S. border illegally, leading to a complex negotiation pairing the largely unrelated issues.
President Joe Biden, a Democrat seeking reelection in 2024, said on Wednesday that he would be willing to make significant concessions on border security as Senate Republicans rejected a Democratic aid package with $20 billion in border funding.
The White House would be open to heightening the standard for initial asylum screenings, a source familiar with the matter told Reuters, requesting anonymity to discuss the talks.
The Biden administration also would entertain some form of a "safe third country" provision that would deny asylum to migrants who pass through another country en route to the U.S., the source said.
Another possible point of agreement could be expanding a fast-track deportation process known as "expedited removal." The authority would be employed nationwide instead of its current application at the border, the source said.
A bipartisan group of senators trying to reach a deal are also discussing a numerical limitation on asylum claims, the source said. The Biden administration position on such a cap remains unclear.
White House spokesperson Angelo Fernandez Hernandez said Biden has made it clear "the border is broken" and that Congress should take action to fix it.
"The president has said he is open to compromise," he said in a statement.
The Republican-led House of Representatives is scheduled to wrap up work for the year by Dec. 14, leaving a tight window to pass legislation. The Democratic-led Senate faces a similar timeline.
With that in mind, the goal seems more to strike a top-line deal and perhaps work on the exact details of the legislative text over the break, sources said.
Democratic Senator Chris Coons said Thursday the gap between his party and Republicans remains "stubbornly large" but that he remains optimistic they can find common ground.
White House spokesperson Karine Jean-Pierre criticized Republicans during a press briefing on Thursday.
"They are playing chicken with our national security," she said. "History will remember them harshly."
Republican Senator Thom Tillis, part of the bipartisan group trying to hash out a border security compromise, told reporters on Wednesday that any proposal would have to cut illegal immigration at least by half and that he did not know if a deal could be reached before Christmas.
A coalition of parental rights and child advocacy groups have accused California Attorney General Rob Bonta of attempting to mislead voters over a ballot initiative title and summary they say is skewed in favor of his political stance on “gender affirmation.”
The ballot initiative would require schools to notify parents if their child changes his or her gender identity, protect the integrity of girls’ sports by prohibiting boys who claim to be girls from competing in them, and ban the use of puberty blockers, cross-sex hormones, and surgery on minors.
However, the state attorney general wrote the ballot initiative title as “Restricts Rights of Transgender Youth,” and the summary is “overtly biased,” “completely absurd,” and “wrong,” said Jonathan Zachreson, spokesman of Protect Kids California, the coalition of parental rights groups that launched the initiative.
“It’s so bad it’s laughable,” he said. “Our initiative protects kids. It doesn’t restrict rights.”
The coalition opposes any kind of medical intervention, including “chemical sterilization” and “genital mutilation” to treat gender dysphoria that could affect the future reproductive health of children, he said.
In late August, the coalition launched three separate initiatives, which have since been consolidated into a single initiative known as the “Protect Kids of California Act of 2024.”
The coalition received the ballot title and summary on Nov. 29 and now has less than 180 days to collect the 546,651 qualified signatures needed for the statewide initiative to be placed on the Nov. 5, 2024, general election ballot.
The ballot summary from the attorney general’s office reads:
Requires public and private schools and colleges to: restrict gender-segregated facilities like bathrooms to persons assigned that gender at birth; prohibit transgender female students (grades 7+) from participating in female sports. Repeals law allowing students to participate in activities and use facilities consistent with their gender identity.
Requires schools to notify parents whenever a student under 18 asks to be treated as a gender differing from school records without exception for student safety.
Prohibits gender-affirming health care for transgender patients under 18, even if parents consent or treatment is medically recommended.
It continues: “Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and, local governments: Potentially minor savings in state and local health care costs of up to millions of dollars annually from no longer paying for prohibited services for individuals under the age of 18. These savings could be affected by many other impacts, such as individuals seeking treatment later in life. Minor administrative and workload costs to schools, colleges, and universities, up to several millions of dollars initially. Potential, but unknown, cost pressures to state and local governments related to federal fiscal penalties if the measure results in federally funded schools, colleges, universities, or health care providers being deemed out of compliance with federal law.”
Summary ‘Confusing’
The attorney general’s assertion that the ballot initiative aims to “prohibit transgender female students (grades 7+) from participating in female sports” is “tricky” and “confusing,” while the wording submitted by Protect Kids California clearly defines what male and female mean based on biology, Mr. Zachreson said.
Erin Friday, an attorney and western U.S. regional leader for Our Duty, a group that opposes social, medical, and surgical interventions on minors, told The Epoch Times the ballot title and summary were predictable.
The attorney general, she said, has already shown his “disdain for parental rights,” most recently with his lawsuit against Chino Valley Unified School District’s parental notification policy regarding gender transitions at school.
“We knew that Bonta would do everything in his power to undermine the initiative to mislead the voters,” she said. “We are disgusted, but not surprised.”
The lawsuit against Chino Valley “is designed to permit schools to continue the unconstitutional practice of deceiving parents when their students are experiencing gender dysphoria,” she said.
Erin Friday gathers with "Our Duty" supporters at the California state capital building in Sacramento, Calif., on Aug. 28, 2023. (John Fredricks/The Epoch Times)
Both California Gov. Gavin Newsom and Mr. Bonta have pushed for too much state control over parental authority, Ms. Friday said.
While the summary states the initiative would “prohibit transgender female students” from participating in female sports, it doesn’t define what ‘transgender female’ means, deliberately misleading voters unfamiliar with the nomenclature of gender ideology to think it means “girls who believe they are boys” when actually it means physical males, she said.
In addition, the language of “gender-affirming health care” refers to a model that means any child, of any age, regardless of mental health issues, ability to consent, or “absurdity of gender identity” must be affirmed and be given any intervention they request, she said. However, not all professionals agree with this model.
The summary also underestimates the potential cost-savings to taxpayers by “tens of millions” of dollars, because children who undergo sex-change interventions face the “grim and predictable future” of becoming life-long medical patients with a host of side effects, including increased occurrences of cancer, osteoporosis, atrophy of sex organs, heart issues, and other life-altering, perpetual ailments, she said.
Detransitioners, including Layla Jane and Chloe Cole who had double mastectomies as minors—at 13 and 15 respectively—have talked about their ongoing discomfort from the surgeries, she said.
The Attorney General’s press office stated via email in response to a request for comment that the Attorney General’s Office is responsible for issuing official titles and summaries “describing the chief purpose and points of every proposed initiative submitted in compliance with procedural requirements,” but did not respond to questions about the alleged bias and ambiguity in the title and summary including, “What defines a ‘transgender female?’”
“We take this responsibility seriously,” the press office stated. “However, we cannot comment on any particular initiative,” the press office stated.
Workers process California ballots at a Los Angeles Registrar site at the Los Angeles Fair Grounds in Pomona, Calif., on Aug. 31, 2021. (John Fredricks/The Epoch Times)
Bigger Picture Unfolds
Before almost every election in California, the wording of ballot measure titles, summaries, text, and rebuttals is enough to leave even the most politically astute voters feeling confused—even duped, according to two former state legislators.
Lawsuits over allegedly twisted ballot titles and summaries are nothing new to California, and the controversy is well-documented in news reports by several media outlets.
Former Assemblyman Kevin Kiley (R-Rocklin), now a congressman, and former state Sen. Melissa Melendez (R-Lake Elsinore) told The Epoch Times preceding the 2020 election that state ballot measure texts and summaries are so skewed, many voters have no idea what they are truly voting for or against come election time.
The problem, they said, is that in California, the authority and responsibility to write fair and impartial ballot titles and summaries rests with the attorney general—a partisan political office—who crafts the wording in a way that leads voters in his or her desired direction.
Mr. Kiley called the practice “terrible” and said it amounts to “election fraud,” because it manipulates the language “in a way that likely changes the whole outcome of the vote.”
“It’s time we finally protect the integrity of our elections by putting a neutral nonpartisan official in charge of writing the ballot language,” Mr. Kiley said in August 2020.
Mr. Kiley and Ms. Melendez said at the time they wanted to avoid further lawsuits and hand over the authority for wording ballot measure titles and summaries to the nonpartisan Legislative Analyst’s Office (LAO), and they even proposed legislation, Assembly Constitutional Amendment 7, or ACA 7, to do just that. However, the proposed amendment was killed in committee and never put to a vote.
In 2020, several lawsuits were filed against then Attorney General Xavier Becerra or his wording of ballot titles and summaries, but his office denied they were biased.
“The elections code is very clear. ... It says you have to give a true and impartial statement on the purpose of the measure, and it’s not supposed to be used as an argument or to create prejudice for or against a measure,” Ms. Melendez said.
On Nov. 4, 2014, California voters passed Proposition 47, a referendum that proponents touted as the Safe Neighborhoods and Schools Act, and opponents such as the California Police Chiefs Association called the ballot title and summary misleading.
At the time, voters were told Prop. 47 was intended to keep nonviolent criminals out of state prison by downgrading some crimes from felonies to misdemeanors, thus saving money on housing inmates. The saved money would then go into a fund to support schools as well as rehabilitation programs, including providing offenders with counseling, therapy, housing, and job opportunities.
Critics, including a county supervisor who originally supported the measure, say the law has instead resulted in an increase in shoplifting and property theft crimes in the state.
Potential Lawsuit
Mr. Zachreson told The Epoch Times it’s not worth suing over the misleading ballot title and summary and risk a potential drawn-out court battle that could prevent the initiative from being on the 2024 ballot.
If there is a court battle, it will come after the state prints the ballot title and summary in its official voter guide, he said.
Meanwhile, the “biased” language could backfire on Mr. Bonta, he said.
“It’s so wrong and absurd that in some ways, I don’t know if it even does the other side a favor, because it’s going get more people to turn their heads and look at what we’re actually trying to accomplish,” Mr. Zachreson said.
The state law that puts the attorney general in charge of ballot titles and summaries is a “direct conflict of interest,” he said. “It should be nonpartisan, impartial, and I think the Legislative Analyst’s Office is a good starting point.”
A Worldwide Stop the War Against Children Rally to protest the sexualization of children, secret gender transitions of minors, and pornographic books at schools, and other issues in Sacramento, Calif., on Oct. 21, 2023. (Courtesy of Julius Giles)
Politics and Polls
A Rasmussen poll published in June, found that 71 percent of American adults believe there are only two genders, and the majority “support laws against transgender treatment for minors.”
Another Rasmussen survey in December 2021 showed 68 percent of Americans don’t believe schools and teachers should be allowed to counsel students on their sexual and gender identities without parental knowledge or consent, and that only 19 percent believe schools should be allowed to engage in such counseling without parental consent.
“Voters are in such strong support, we know that we can win, so the hardest part is just to get on the ballot,” Mr. Zachreson said. “That’s where we’re at now and we feel we can do it.”
But because most Democratic politicians in California are “vehemently against” the tenets of the ballot initiative, and Democrats hold a super majority in the state, “there is no way that we’re going to be able to persuade the legislature,” he said.
And, although litigation has worked to some extent to fight against gender ideology in schools, he said the ballot initiative is a more direct route to democracy.
Even if the state loses its legal battle against Chino Valley and the district is allowed to enforce its parental notification policy, parental rights groups would still have to convince nearly 1,000 other school districts to adopt similar policies, whereas a successful ballot measure would make parental notification policies a statewide law, he said.
The Petition
Protect Kids California has set a goal of 850,000 signatures to make sure it has ample qualified signatures to make the 2024 ballot, Mr. Zachreson said.
The 546,651 qualified signatures needed are based on five percent of the number of voters in the last gubernatorial election.
“We’ll also do our own signature verification to minimize any issues there,” he said.
Mr. Zachreson said petition forms for the ballot initiative will soon be available for download from the Protect Kids California website.
Former collegiate swimmer Riley Gaines, a National Collegiate Athletic Association record setter who testified before Congress in support of Title IX on Dec. 5, urged more than 300 people at a California Family Council event in Costa Mesa, Calif., on Nov. 30 to support all aspects of the ballot initiative.
Biogen (NASDAQ:BIIB) shares rose 1.6% on Thursday after at least two analysts weighed in positively on the outlook for the biotech giant.
Raymond James analysts upgraded the rating to Outperform from Market Perform with a price target of $283 per share.
The upgrade is based on the expectation that the Leqembi launch will gain momentum in 2024, especially with the availability of the SC formulation.
The Skyclarys U.S. launch is anticipated to maintain a robust pace in 2024 and will be further strengthened by approval and launch in the EU early next year.
Moreover, the expectation is that BIIB leadership will continue to be prudent with research and development spending, leading to steady improvements in operational expense margins.
-- Recorded Second Quarter Revenue of $25.4 Million --
-- Signed $35 Million in Net New Business Orders Resulting in a Backlog of $199 Million --
-- Entered into Partnership with California Institute of Regenerative Medicine (CIRM) to Advance Manufacturing of Adeno-Associated Adenovirus, as well as Other Cell and Gene Therapy Programs –
-- Completed Construction of Cell and Gene Therapy Facility; Grand Opening Scheduled for January 2024 --
-- Adjusting Fiscal 2024 Revenue Guidance to $137 to $147 million --
