Albert Bourla, Pfizer CEO (Getty Images)
A new private study by South Africa’s largest insurer, Discovery Health, suggests that Pfizer and BioNTech’s Covid-19 vaccine is just 33% effective against infections by the Omicron variant.
However, the variant appears to cause less severe disease, the company reported. The data, based on 211,000 positive Covid cases, showed that risk of hospitalization was 29% lower than in South Africa’s first wave back in mid-2020.
The Pfizer/BioNTech shot was 70% effective at preventing severe disease that requires hospitalization, which health officials are saying is important. Discovery Health added that these data are still preliminary.
‘This is true, that where Omicron has been gaining steam, the proportion of hospitalizations is lower than expected, which is great,’ Eric Topol, vice president for research at Scripps Research, posted yesterday in a blog.
‘But make no mistake, Omicron has the potential to induce an enormous number of infections worldwide and even if severe Covid is one-tenth that of Delta or preceding variants, in absolute numbers it could lead to a major toll of hospitalizations or deaths,’ he added later on.
The news comes as Omicron has already become the dominant strain in South Africa — and officials say it could become the dominant strain in London any time now, per a Reuters report.
John Mascola, head of the NIH’s Vaccine Research Institute, called the variant ‘another stress test,’ the first big one since the winter of 2020. The WHO has declared a ‘100 Days Mission,’ aiming to have a solution in 100 days if Omicron turns out to be a true viral escape variant.
‘The Omicron-driven fourth wave has a significantly steeper trajectory of new infections relative to prior waves. National data show an exponential increase in both new infections and test positivity rates during the first three weeks of this wave, indicating a highly transmissible variant with rapid community spread of infection,’ Discovery Health CEO Ryan Noach said in a statement.
Serum Institute of India prepares to launch Novavax vaccine for children — report
The Serum Institute of India says it’s about six months away from launching Novavax’s Covid-19 vaccine for kids, according to a Reuters report.
‘Our vaccine will be launched in six months,’ CEO Adar Poonawalla said, per Reuters. ‘It is under trial and has shown excellent data all the way down to the age group of 3.’
Novavax hit a few snags in submitting its recombinant protein vaccine to US regulators. The company has struggled with potency and purity, pushing back the timing of submitting its application to the FDA all summer. Last month, execs said in an SEC filing that they had ‘validated the potency and purity of our assays,’ and planned on filing for authorization in the US by the end of the year.
However, it’s unclear how the vaccine fares against the Omicron variant. A couple weeks ago, Novavax unveiled plans to start developing an Omicron-specific vaccine early next year, Reuters reported.
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%).
When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.
Now Pfizer wants to give the pharma rival a run for its money.
Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.
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Sen. Ron Wyden (D-OR) (Graeme Sloan/Sipa via AP Images)
It’s no longer a secret that the US government is going to have to pay for Biogen’s new and expensive Alzheimer’s drug Aduhelm on the backs of huge increases in Medicare premiums.
CMS explained last month that Medicare Part B will have to increase (by the largest amount ever) its standard monthly premium — from $148.50 in 2021 to $170.10 in 2022 — in part because of the massive spending that could occur should CMS sign off on a national coverage decision for Aduhelm, and its $56,000 annual price tag next year.
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Harpreet Singh, Immatics CEO (Credit: Allogeneic Cell Therapies Summit)
Just a few weeks after offering a positive readout on its first early clinical-stage offering, the transatlantic biotech Immatics is back with news that the research crowd around Rupert Vessey at Bristol Myers Squibb has anted up $150 million in cash to get on at the ground floor with one of their still-preclinical efforts.
This time the news is centered on IMA401, Immatics’ most advanced bispecific, which uses one binder to latch on to MAGEA4/8 while another is used to whip up T cell activity against tumor cells where that’s a common antigen. For now, that’s still a preclinical effort, with the first human trial set to launch in the first half of next year.
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AnHeart Therapeutics co-founder and CEO Jerry Wang (L); co-founder and CBO Lihua Zheng (R)
In China, the character 安, pronounced An in English phonics, has a few different translations — yet they all come to the same general meaning: calm, safe, comfortable.
And for precision oncology biotech AnHeart Therapeutics, that Chinese character helps to define the company’s objective.
‘In Chinese, the pronunciation actually means something — [it] has special meaning: calm, safe, comfortable. So it’s really — you have a very calm heart, comfortable heart full of patients. So we try to make medicine so the patient can feel comfortable, feel safe. Feel calm,’ AnHeart CBO and co-founder Lihua Zheng told Endpoints News.
Australia’s CSL is plopping down $11.7 billion to acquire Vifor Pharma, the Swiss biotech best known for its iron products and kidney drugs.
While the buyout comes as little surprise — rumors have swirled since early December, and Vifor actually confirmed the deal talks to media on Monday — the final price could raise some eyebrows.
At $179.25 per share, CSL’s offer comes in much higher than the ‘more than $8.5 billion’ price tag cited in reports.
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Soon after San Francisco-based Genentech won an EUA for tocilizumab as a treatment for hospitalized Covid patients last summer, the company announced a shortage of the drug while pointing to the emergence of the Delta variant and the slowing of vaccination rates across the US.
‘This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV– well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase,’ the company said in August.
Merck’s potential Covid-19 treatment molnupiravir will not be used in France, French regulators said Friday.
The French National Authority of Health cited the potential impact of the Omicron variant, the fact that Regeneron’s mAb cocktail is more effective, and the pill’s own lack of efficacy as reasons for denying early access of the drug to patients experiencing mild to moderate cases of Covid-19. France has already pre-ordered hundreds of thousands of the pills, with the goal of treating 50,000 patients.
The current generation of cell therapies has proven a game changer in terms of treating aggressive blood cancers, but the tech has its limitations. Novartis, one of the biggies in the current generation of these drugs, is now taking lessons learned from CAR-T Kymriah to supercharge a ‘second-generation’ of CAR-Ts putting superior cells into patients faster.
Novartis on Monday rolled out early Phase I data for a pair of autologous CAR-T cell therapies developed through the drugmaker’s T-Charge platform, a process designed to promote T cell ‘stemness’ — a measure of a cell’s ability to self-renew — by cutting manufacturing times and spurring cell proliferation primarily in patients’ lymph nodes.
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https://endpts.com/covid-19-roundup-study-suggests-omicron-variant-could-escape-protection-of-pfizer-biontech-vaccine-serum-institute-prepares-launch-of-novavax-shot-for-children-report/
