Stéphane Bancel (AP Images, Boston Herald)
While an Omicron-specific booster of Moderna’s Covid-19 vaccine probably won’t be ready in the next couple of months, according to a Reuters report, CEO Stéphane Bancel says another shot will likely be necessary for the fall.
‘I still believe we’re going to need boosters in the fall of ’22 and forward,’ Bancel said at a Goldman Sachs-organized event, per Reuters.
The news comes days after Israel Prime Minister Naftali Bennett announced that a study conducted in the country suggests a fourth Covid-19 vaccine dose spurs a five-fold increase in antibodies just a week after being administered.
Bancel said in a recent letter to investors that Moderna continues to evaluate variant-specific and multivalent vaccines (combinations of variant specific vaccines) to stay ahead of future variants, including Omicron.
‘In addition, we are evaluating mRNA-1283 as a next generation, refrigerator stable vaccine,’ he wrote.
Just before the new year, Bancel revealed preliminary data suggesting a booster dose of its original vaccine, mRNA-1273, was enough to kick up Omicron neutralizing antibody levels dramatically. The currently authorized 50 µg booster increased Omicron-specific antibodies around 37-fold compared to pre-boost levels, researchers reported, while a 100 µg dose increased neutralizing antibody levels approximately 83-fold.
J&J touts real-world data supporting a single dose of its vaccine
The CDC recommended weeks ago that Americans receive one of the mRNA vaccines over J&J’s single-dose vaccine due to renewed concerns about blood clots. But the pharma giant isn’t backing down.
On Thursday, J&J unveiled new real-world data that suggest a single shot of its Covid-19 vaccine offered protection against breakthrough infections, hospitalizations, and ICU admissions for up to six months.
It’s important to note that data from the J&J-sponsored trial are preliminary, and have yet to be peer-reviewed. And they were collected before the Omicron variant was discovered.
One month post-vaccination, J&J reported efficacy rates of 81% for preventing hospitalization and 74% for preventing breakthrough infections. Over the course of six months, the pharma said there was no evidence of waning protection against hospitalizations or Covid-related ICU admissions. However, there was some ‘modest waning’ of protection against breakthrough infections starting in month 4.
J&J noted that waning protection against breakthrough cases began in month 2 for both the Moderna and Pfizer/BioNTech shots.
The study was conducted using national claims, lab and hospital data for 17 million fully-vaccinated individuals between Jan. 1 and Sept. 7, 2021.
A few weeks ago, the CDC recommended against taking J&J’s shot if either the Pfizer/BioNTech or Moderna shot is available, over concerns about rare but sometimes fatal blood clots. J&J’s vaccine will still be available to those who are unable or unwilling to get an mRNA vaccine. ‘We continue to undertake extensive efforts to study the durability of protection offered by the Johnson & Johnson vaccine amidst the ever-changing COVID-19 pandemic,’ Mathai Mammen, Janssen’s executive VP of pharmaceuticals, said in a statement.
The FDA and CDC put a hold on 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 the shot’s known and potential benefits still outweigh the risks.
But at an 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.
J&J put out a statement that it remains confident in the vaccine’s benefit-risk profile.
A district court in Texas will likely tie up the FDA’s FOIA office for months, as the court ruled late Thursday that the agency must release all documents related to its review of Pfizer-BioNTech’s Covid-19 vaccine.
The order from district judge Mark Pittman, handed down late Thursday, notes that while the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA, there also ‘may not be’ a more important issue at the FDA right now than the pandemic, the Pfizer vaccine, getting every American vaccinated, and making sure to the American public that the process was not rushed.
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Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Exscientia CEO Andrew Hopkins and Sanofi CEO Paul Hudson
Drug R&D has for years had an abysmal track record of success, with the vast majority of drug candidates never making it to market. The promise of AI to shorten the discovery time for new drugs and up their chances of success has more big drugmakers buying in — and Sanofi is the latest.
Sanofi will pay $100 million upfront with a potential $5.2 billion in downstream milestones for access to up to 15 small molecule drugs from Exscientia, a red-hot UK deep learning company at the forefront of the so-called ‘AI-discovered’ drug R&D movement, the partners said Friday.
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Aligos Therapeutics took a beating Thursday after reporting it is stopping development on its lead program for chronic hepatitis B.
The biotech’s shares $ALGS closed down 57% and fell into penny stock territory Thursday, following a morning press release saying Aligos’ ALG-010133 program did not prove efficacious at the dose tested in a Phase I study. Additionally, the company concluded that higher doses were also unlikely to be effective, and ultimately decided to axe the candidate altogether.
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For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
After 18 years at the FDA and climbing the corporate ladder in biopharma, Vicki Goodman is now in the biotech C-suite for the first time. The new CMO and executive VP of product development for Exelixis started on Dec. 4, flying out to the biotech’s headquarters just outside sunny San Francisco before returning home and flying all the way back to Philly, where she is based.
Goodman got her passion for medicine as a young child — it didn’t surprise anyone that she majored in biochemistry before going through medical school and residency, finishing up in the early 2000s with an emphasis in internal medicine, medical oncology and hematology. But for her, there was an underlying desire to use science to help people and work on problems that impact people’s health.
Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)
AstraZeneca — or, more specifically, its rare disease subsidiary Alexion — is serious about getting into ATTR amyloidosis.
Just weeks after licensing a late-stage antisense candidate from Ionis, AstraZeneca has struck another deal to pick up a Phase Ib antibody hitting the same target, this time from Swiss biotech Neurimmune.
The upfront from Alexion comes in at $30 million, with the potential to add up to $730 million in milestones. Alexion is hoping the program would tackle transthyretin amyloid cardiomyopathy, or ATTR-CM, which is characterized by cardiac buildup of toxic amyloid fibrils.
Roger Perlmutter, Eikon CEO
Roger Perlmutter hasn’t wasted any time since announcing his supposed retirement from Merck in October 2020. After leaving his perch as one of the most successful R&D chiefs in Big Pharma, he’s now snatching a cool half-billion dollars to develop ‘a battery of innovative tools’ for drug discovery at the young startup Eikon Therapeutics.
Eikon closed on a $517.8 million Series B round on Thursday morning, bringing the Hayward, CA-based company’s total raise to more than $668 million.
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As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.
The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.
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