The US Food and Drug Administration said Friday it had told Johnson & Johnson that millions of doses of Covid vaccine produced at a troubled plant can't be used because of possible contamination issues.
In a statement, the FDA said "several" batches of vaccine manufactured at the Emergent BioSolutions facility in the city of Baltimore are not suitable for use. Each batch is known to correspond to several million doses.
Neither the agency nor J&J revealed the precise number of doses, but The New York Times placed the number at 60 million, quoting people familiar with the matter.
"These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product," said FDA scientist Peter Marks.
The Emergent plant was ordered to pause production in April several weeks after it was determined that batches of substance used to produce the J&J vaccine were cross-contaminated with ingredients from the AstraZeneca vaccine, ruining a reported 15 million J&J doses.
The FDA is still deciding whether to allow the factory to reopen. Sixty million AstraZeneca doses produced there and earmarked to be donated abroad are currently being inspected for quality before they can be shipped.
All of the J&J vaccines distributed and used in the United States so far were made in the Netherlands, not in Baltimore.
On the other hand, the FDA said it was greenlighting two batches of J&J vaccine made at the plant -- that is to say, 10 million doses of the one-shot regimen, a source familiar with the matter said.
Additional J&J batches remain under review.
"Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere," said J&J executive vice president Kathy Wengel.
Meanwhile, Canada on Friday announced it would not distribute 300,000 doses of the J&J vaccine made at the Baltimore plant due to quality "concerns."
The country's health authorities planned to inspect the facility this summer.
"Until this inspection has been completed, Canada will not be accepting any product or ingredients made at this site," Health Canada said in a statement.
Turns out the comic books were wrong.
Japanese researchers found mouse sperm exposed to high levels of cosmic radiation for nearly six years produced a large brood of healthy, unremarkable "space pups."
Their study was published Friday in Science Advances -- which noted no signs so far of Mousezillas or rodent Hulks.
The sperm was stored in the International Space Station in freeze-dried form. Once brought back to Earth and rehydrated, it resulted in the birth of 168 young, free of genetic defects.
Developmental biologist and lead author Teruhiko Wakayama told AFP on Thursday that there was little difference between mice fertilized by space sperm and sperm that had remained confined to our planet.
"All pups had normal appearance," he said, and when researchers examined their genes "no abnormalities were found."
In 2013, Wakayama and colleagues at the University of Yamanashi in Japan launched three boxes, each containing 48 ampoules of freeze-dried sperm, to the ISS for the long-term study.
They wanted to determine whether long term exposure to radiation in space would damage DNA in reproductive cells or pass mutations along to offspring.
That could be a problem for our own species in future space exploration and colonization missions.
Batches were returned to Earth for fertilization after the first nine months, then after two years, and finally after six years, leading to hundreds of births.
Freeze-dried sperm was selected for the experiment because it can be preserved at room temperature, rather than needing a freezer.
The ampoules were also small and very light, about the size of a small pencil, further cutting launch costs.
When the space mice reached adulthood, they were randomly mated and the next generation appeared normal as well.
Wakayama, now director for Advanced Biotechnology Center at the University of Yamanashi, told AFP he had been inspired by the science fiction of Heinlein and Asimov and once wanted to be an astronaut.
Though he settled on becoming a scientist, the sense of wonder and whimsy about space exploration never left him.
"In the future, when the time comes to migrate to other planets, we will need to mantain the diversity of genetic resources, not only for humans but also for pets and domestic animals," Wakayama and colleagues wrote in their paper.
"For cost and safety reasons, it is likely that stored germ cells will be transported by spaceships rather than by living animals."
Getting to other planets means leaving the safety of Earth's protective atmosphere and magnetic field -- which also extends to the ISS, 400 kilometers (250 miles) above the surface.
Deep space is filled with strong radiation from both solar particles and galactic cosmic rays from outside our system.
Solar flares from the surface of the Sun generate particles that can have particularly devastating impacts on human health and penetrate current generation spaceships.
According to Wakayama, the process of freeze drying sperm increases its tolerance compared to fresh sperm, since the former does not contain water inside its cell nuclei and cytoplasms.
According to the team's calculations, freeze-dried sperm could be stored for up to 200 years on board the orbital outpost.
Humanity might also want to spread its genetic resources off planet in case of a disaster on Earth, the paper added.
The study noted it is still necessary to investigate the effects of space radiation on frozen female eggs and fertilized embryos before humans take this next step into the space age.
The same split that is dividing Republicans nationally, whether to embrace or reject the fiction that the 2020 presidential election was illegitimate, is now reverberating backstage at the Veterans Memorial Coliseum in Arizona, where pro-Trump contractors are leading a state-sponsored inquiry into the vote in Maricopa County, home to Phoenix and 60 percent of Arizona voters.
The state Senate's lead contractor, Florida-based Cyber Ninjas, whose CEO Doug Logan had said that Joe Biden's victory was illegitimate, has been opposing an effort to widen the Arizona Senate's inquiry—via another assessment that vets the 2020 vote more thoroughly. Logan also has sought to muzzle and even oust the lead proponent of that more detailed inquiry, former Arizona Secretary of State Ken Bennett, a Republican. Senate President Karen Fann asked Bennett to take the role of Senate audit liaison after she hired Cyber Ninjas. He is not taking any compensation for his role, unlike Cyber Ninjas and the subcontractors.
Beyond the personality clashes involved, which Voting Booth heard about while reporting from Phoenix as a hand count of 2.1 million paper ballots was nearing completion, is an emerging bottom line: Cyber Ninjas has spent several million dollars and two months conducting inquiries that are not poised to present sufficient analyses that can legitimately assess the presidential results.
Cyber Ninjas' inquiries, which include a hand count of all paper ballots and looking for forged ballots based on high-resolution and microscopic examination of the ballot paper and ink marks, are generating reams of information that could be cited in partisan propaganda—which is how pro-Trump media outlets have covered the audit from its inception.
Crucially, the data Cyber Ninjas is accumulating has not been compared to the building blocks of the state-certified vote count. At best, it is conducting a loosely constructed recount, which is not an audit—which is based on comparisons.
"There must be comparable results in sufficient detail, or else it is not an audit," said Larry Moore, the retired founder and CEO of Clear Ballot, a federally certified audit firm. "It is unacceptable to put out anything less."
Moore is not an unbiased observer in Phoenix. He has criticized the inquiries and is part of a team of seasoned election auditors that has parsed the same official records given to Cyber Ninjas after a Senate subpoena. The team's early analysis confirmed that Joe Biden won in Arizona and offered an explanation why. The official records revealed voting patterns showing that tens of thousands of voters supported most Republicans on their ballots—but did not vote for Trump.
Moore's team, which is locally led by Tucson's Benny White, who is a longtime Republican Party observer in state and local elections, has shared its findings with news organizations in Phoenix, whose coverage is beginning to reframe how the Senate's exercise should be evaluated.
The team has gone further in recent days. They challenged Cyber Ninjas to take their subtotals (gleaned from the official election data) and compare it to the subtotals in a sealed box of ballots. By June 11, there were several dozen boxes of ballots that had not yet been opened and hand-counted. Cyber Ninjas did not take up the challenge.
The auditors then gave their data to the press, including reporters who have observed Cyber Ninjas revising their procedures repeatedly in recent weeks. The evaluation pushed by Moore and White would directly compare the paper ballots marked by voters, the starting line, to the official election results, the finish line, to attest to the election's accuracy. Cyber Ninjas' process isn't making this comparison.
Growing Pressure Inside and Out
That fundamental procedural flaw, meanwhile, has bothered Bennett, the former Arizona secretary of state who says he volunteered to be Senate liaison because he felt that doubts about the election's legitimacy had to be put to rest. Since April, he has expressed interest in expanding the Senate's audit's inquiries to parse the electronic records that detect votes on the paper ballots and then compile the overall results.
Bennett has been pushing for a so-called ballot image audit to do this assessment, which would compare the digital images of every ballot created by vote-counting scanners to the electronically compiled vote totals. Bennett has attempted to hire a California nonprofit, Citizens Oversight, that happens to be run by a Democrat for that specialized assessment. But that prospect has been attacked in right-wing media and on social media, including by the audit's contractors led by Logan.
Inside the Phoenix arena, there are reports that Logan has told Bennett—who also is a former Arizona Senate president—not to talk to the press. Logan has reportedly bad-mouthed Bennett in closed meetings with pro-Trump activists and legislators visiting from out of state—who are seeking to bring similar privatized partisan assessments to their states (after Trump also lost there). It is clear, according to interviews by Voting Booth with witnesses to these incidents, that Logan's allies fear that more investigations would expose their shortcomings and undermine whatever report they issue.
Thus, among other things, pushing Bennett out of the inquiry would seem advantageous to pro-Trump Republicans' efforts to discredit the integrity of the 2020 election. In response, Bennett said that he is committed to examining Maricopa County's 2020 ballots and vote counts as thoroughly as possible, because he said that he is still a trusted messenger to enough Arizona Republicans who are awaiting his verdict.
"It's not what evidence is presented to most people, it's who it is presented to them by," Bennett said. He added that he wants to look at what Cyber Ninjas' analysis, the analysis by Moore and White, and what Citizens Oversight may do, and then present his judgment, and, if necessary, the details leading to his evaluation, to dispel any doubts.
"I believe that we can convince 90 percent of the people that are questioning the election [of its legitimacy], because it was the opposite party that was questioning the results in 2016. Ninety percent can understand that if Trump lost the election, it was Trump that lost the election," Bennett said. He mentioned several debunked conspiracy theories about the 2020 election in Arizona, saying, "It wasn't ballots flown in at midnight from China. It wasn't any fractional counting of votes on voting machines. It wasn't because Dominion [Voting Systems] was owned by China or Russia, or I don't know who… And similarly, when the Democrats lose, maybe it's because Hillary Clinton just wasn't what the American people wanted in 2016."
Steven Rosenfeld is the editor and chief correspondent of Voting Booth, a project of the Independent Media Institute. He has reported for National Public Radio, Marketplace, and Christian Science Monitor Radio, as well as a wide range of progressive publications including Salon, AlterNet, the American Prospect, and many others.
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