The CDC has officially recommended that Americans receive one of the mRNA vaccines over J&J’s single-dose vaccine due to renewed concerns about rare but sometimes fatal blood clots.
The decision followed a unanimous vote by the Advisory Committee on Immunization Practices (ACIP) to recommend against taking J&J’s shot, if either the Pfizer/BioNTech or Moderna shot is available. J&J’s vaccine will still be available to those who are unable or unwilling to get an mRNA vaccine.
Supply won’t be an issue, according to the CDC, with nearly 100 million mRNA doses in the field for immediate use.
Thrombosis occurs when blood clots block blood vessels. The FDA and CDC put a hold on the rollout of J&J’s vaccine back in April to assess the risk of such blood clots, but ended up lifting the pause less than two weeks later after deciding that shot’s known and potential benefits still outweigh the risks.
But during the ACIP meeting, it was revealed that there are more cases of thrombosis with thrombocytopenia syndrome (TTS) in those who received the J&J vaccine than previously thought, with at least 54 cases and 9 deaths in the US.
J&J issued a statement that it remains confident in the vaccine’s benefit-risk profile, and will continue to collect data in coming weeks on activity against the Omicron variant.
‘We appreciate today’s discussion and look forward to working with the CDC on next steps,’ said Mathai Mammen, global head of Janssen’s R&D. ‘In addition, we strongly support education and generating awareness of rare events, such as Thrombosis with Thrombocytopenia Syndrome (TTS) and how to effectively manage it.’
According to data presented during the ACIP meeting, TTS death rates are highest among women between 30 and 39 years old (1.93 per million doses) and 40 to 49 years old (1.8 per million doses).
‘Today’s updated recommendation emphasizes CDC’s commitment to provide real-time scientific information to the American public,’ CDC director Rochelle Walensky said in a statement. ‘I continue to encourage all Americans to get vaccinated and boosted.’
EU considers deal for variant-specific doses of Pfizer/BioNTech vaccine
European Union member states have agreed to purchase over 180 million doses of Pfizer and BioNTech’s still experimental Covid-19 vaccine adapted for the Omicron variant, European Commission president Ursula von der Leyen said during a news conference.
‘The Member States have agreed to trigger a first tranche of over 180 million extra doses of adapted vaccines, in our third contract with BioNTech-Pfizer,’ von der Leyen said during a news conference.
Our contracts foresee that the companies will develop adapted vaccines, if requested, within 100 days. Member States have agreed to trigger a first tranche of over 180 million extra doses of adapted vaccines, in our 3rd contract with @BioNTech_Group – @pfizer
— Ursula von der Leyen (@vonderleyen) December 17, 2021 The comments come after Pfizer released data suggesting its two-dose series may not be sufficient to protect against the Omicron variant. Pfizer reported a more than 25-fold reduction in neutralizing titers against the Omicron variant — and earlier this week, preliminary data from a South African study suggested the vaccine is just 33% effective against infections by the Omicron variant.
However, the two-dose vaccine appeared to be 70% effective at preventing severe disease that requires hospitalization, according to the data from South Africa.
Pfizer says a third booster dose of the same vaccine ‘provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron.’
Plus, it’s working on an Omicron-specific booster with BioNTech, which the companies say could be ready in March 2022.
Pfizer, though, told Reuters that discussions with the EU had so far not concerned adapted boosters.
‘At this time, discussions with the EC about the potential for additional supply pursuant to their option rights under our agreement are not specific to an adapted vaccine,’ the company said, per Reuters. Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)
Since the pandemic began, the FDA has allowed women to access the abortion drug mifepristone via the mail, making it easier for them and ensuring that they don’t have to go to a clinic to receive the pills.
The FDA’s temporary change became permanent on Thursday afternoon, with the FDA announcing that the REMS on mifepristone (brand name Mifeprex) and its generic versions must be modified by removing this in-person dispensing requirement.
Pascal Prigent, Genfit CEO
Somebody believes in elafibranor after all.
The drug, which had been considered a bright prospect in the failure-prone but highly lucrative race to treat non-alcoholic steatohepatitis, imploded after it failed a closely watched trial, forcing its developer, Genfit, to throw in the towel. But after a lonely year steering past the wreckage — chopping nearly half of its workforce in a painful restructuring — Genfit has found a trusting partner in fellow French drugmaker Ipsen.
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A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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Stigma around lung cancer likely isn’t going away — the ‘you did it to yourself’ critics continue no matter the statistics or circumstances presented. So instead Novartis is encouraging people with lung cancer to self-advocate and have meaningful conversations where it matters.
Its ‘Sound Up for Lung Cancer’ campaign focuses on the power patients do have. In videos that center on patients’ voices, for instance, people talk about how they felt blamed or isolated after diagnosis and how they dealt with it. As one woman says, ‘Connecting with other people going through it and focusing on what’s important. That’s what helped me find my normal again.’
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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
https://endpts.com/covid-19-roundup-cdc-recommends-mrna-vaccines-over-j-eu-considers-deal-for-variant-specific-doses-of-pfizer-biontech-vaccine/
