Biotech week ahead, Sept. 20

Biotech stocks declined for the week ending Sept. 17, extending the losses from the previous week. European Society for Medical Oncology presentations, vaccine news, clinical readouts and IPOs were among the catalysts for the week.

The week started off on a weak note for COVID-19 vaccine stocks after a scientific review published in the Lancet suggested that booster doses of vaccines may not be warranted at this point in time. An FDA Advisory Committee that met Friday voted against recommending Pfizer, Inc. 

PFE +1.3%

 (Get Free Alerts for PFE)-BioNTech SE 

BNTX +3.61%

 (Get Free Alerts for BNTX)'s third COVID-19 booster shot for the general population.

On the regulatory front, the Food and Drug Administration gave its nod of approval for Takeda Pharmaceuticals Company Ltd. 

TAK +0.29%

's Exkivity for the treatment of very rare lung cancer. On the other hand, the review period for Calliditas Therapeutics AB 

CALT +0.29%

's Nefecon as a treatment option for primary IgA Nephropathy was extended by three months.

Four healthcare stocks debuted following their IPOs, raising a combined $564.7 million in gross proceeds.

Here are the key catalysts for the unfolding week:

Conferences

European Society for Medical Oncology, or ESMO, 2021 Congress: Sept. 16-21
International Workshop On CLL, or iwCLL: Sept. 17-20
The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: Sept. 20-23
World Muscle Society, or WMS, 2021 Virtual Congress: Sept. 20-24
3rd RAS-targeted Drug Development Summit: Sept. 21-23
5th Global Summit on Precision Diagnosis and Treatment of Prostate Cancer: Sept. 23-25
16th Meeting of the European Association of Neuro-oncology, or EANO: Sept. 25-26

PDUFA Dates

The FDA is scheduled to rule on Incyte Corporation 

INCY +0.29%

's new drug application for ruxolitinib cream in atopic dermatitis and a supplemental new drug application for ruxolitinib in steroid-refractory chronic graft-versus-host disease. The PDUFA dates for the two applications are Tuesday, Sept. 21 and Wednesday, Sept. 22, respectively.

Verrica Pharmaceuticals Inc. 

VRCA +0.29%

 awaits an FDA decision on its NDA for VP-102 as a treatment option for molluscum contagiosum. The PDUFA date been set for Thursday, Sept. 23.

Clinical Readouts/Presentations

ESMO Congress Presentations

Novartis AG 

NVS +1.08%

: Overall survival results from the phase 3 MONALEESA-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative advanced breast cancer treated with endocrine therapy ± ribociclib (Sunday, Sept. 19, at 8:10 am)

Mirati Therapeutics, Inc. 

MRTX +1.08%

 & Zai Lab Limited 

ZLAB +1.08%

: Data from the CRYSTAL-1 Phase 1/2 study of adagrasib (MRTX849) as monotherapy or combined with cetuximab in patients with colorectal cancer harboring a KRASG12C mutation (Sunday, Sept. 19, at 9:47-9:52 am); Zai Labs has acquired Chinese rights to adagrasib; Phase 2 trial of sitravatinib + Bristol-Myers Squibb Company 

BMY +1.08%

's Opdivo in patients with non-squamous non–small cell lung cancer (Monday, Sept. 20, 8:20-8:30 am)

Veru, Inc. 

VERU +1.08%

: updated clinical data from the Phase 1b/2 study of sabizabulin (VERU-111) in metastatic castration resistant prostate cancer patients who have progressed on at least one novel androgen receptor targeting agent (Sunday, Sept. 19, at 11:30 am-12:10 pm)

Verastem, Inc. 

VSTM +1.08%

: Efficacy data from the Phase I study of the combination of VS-6766 and defactinib in low grade serous ovarian cancer (Sunday, Sept, 19 at 11:50-11:55 am)

Johnson & Johnson 

JNJ +0.36%

: analysis from the Phase 3 ACIS trial of Erleada and Zytiga (abiraterone acetate) plus prednisone in metastatic castration-resistant prostate cancer

Aprea Therapeutics, Inc. 

APRE +0.36%

: Phase 1/2 study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies (Monday, Sept. 20, at 11:35-11:40 am)

iwCLL Presentations

TG Therapeutics, Inc. 

TGTX +0.36%

: Phase 1/2 study of Umbralisib, Ublituximab, and Venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia. The presentation is scheduled for Sunday, Sept. 19, at 10:50 am. The company will also present on Sunday, Sept. 19 at 2 pm, data from the Phase 1 study of G-1701 as monotherapy and in combination with Ublituximab and Umbralisib in patients with chronic lymphocytic leukemia.

WMS Congress Presentations

Sarepta Therapeutics, Inc. 

SRPT +0.36%

: Safety, β-sarcoglycan expression, and functional outcomes from systemic gene transfer of rAAVrh74.MHCK7.SGCB in limb girdle muscular dystrophy type 2E/R4; interim results from the Phase 3 ESSENCE study of casimersen in patients with Duchenne muscular dystrophy amenable to exon 45 skipping; safety and efficacy data from the Phase 2 evaluating SRP-9001 for treating patients with Duchenne muscular dystrophy (Monday, Sept. 20)

Capricor Therapeutics, Inc. 

CAPR +0.36%

: final data from its HOPE-2 clinical trial with asset CAP-1002 in patients with late-stage Duchenne muscular dystrophy (Friday, Sept. 24, at 11:15 am to 12 pm)

Click here to access Benzinga's FDA Calendar

RAS-targeted Drug Development Summit Presentation

Onconova Therapeutics, Inc. 

ONTX +0.36%

: preliminary data from the Phase 1/2 study of rigosertib plus Opdivo in advanced KRAS-mutated NSCLC

Earnings

Applied Genetic Technologies Corporation 

AGTC +0.36%

 (Thursday, after the close)

IPOs

San Diego, California-based Cue Health, Inc. NASDAQHLTH is offering 12.5 million shares of its common stock in an initial public offering, estimated to be priced between $15 and $17. The healthcare tech company expects to list the shares on the Nasdaq under the ticker symbol "HLTH."

https://www.benzinga.com/general/biotech/21/09/23002535/the-week-ahead-in-biotech-sept-19-25-incyte-verrica-fda-decisions-and-conference-presentations-in

Novartis, to dethrone Pfizer, will launch bold Kisqali-Ibrance head-to-head trial in breast cancer

 Despite two life extension wins, Novartis still finds it tough to convince doctors to use its breast cancer drug Kisqali over Pfizer’s first-to-market Ibrance. Now, with a third survival victory under its belt, the Swiss pharma is determined to overthrow its rival—and it's launching an ambitious head-to-head trial to make it happen.

Sunday, Novartis said it’s collaborating with SOLTI Innovative Cancer Research to launch a new phase 3 trial for Kisqali and Ibrance. Dubbed Harmonia, the trial will pit the two CDK4/6 inhibitors—both used on top of endocrine therapy—against each other in patients with the HER2-enriched subtype of HR-positive, HER2-negative advanced breast cancer.

The news comes as Novartis churned out a third clinical trial success for Kisqali at the ongoing European Society for Medical Oncology annual meeting, whereas Ibrance’s clinical programs have yet to report a life-saving benefit for the Pfizer med. And it comes as Ibrance’s U.S. new-to-brand prescription numbers stay about 10 times that of Kisqali’s, despite its lagging behind in clinical data.

“The strength and consistency of the Kisqali overall survival data across the Monaleesa program reinforce there are differences among CDK4/6 inhibitors, and that Kisqali stands apart in its ability to help patients achieve their goal of more quality time,” Susanne Schaffert, Ph.D., president of Novartis Oncology, said in a statement Sunday.

“Harmonia, a novel head-to-head trial, is a testament to our bold development approach and will provide evidence on the unique profile of Kisqali and its unmatched benefit for HR+/HER2- advanced breast cancer patients,” Schaffert added.

With help from Alliance Foundation Trials, the new study will start enrolling patients in the first quarter of 2022 across 80 hospitals in Spain, Portugal and the U.S. The main goal is to see which therapy is better at delaying tumor progression or death. It will also assess whether Kisqali alters tumor biology in a way that enables better response to endocrine therapy compared to Ibrance, according to Novartis.

An exploratory cohort of the study will also enroll patients with a basal-like subtype of tumors, which resemble triple-negative breast cancer. These participants will get chemotherapy alongside the CDK4/6 inhibitors.

Novartis in 2019 unveiled two positive datasets from the Monaleesa-7 and Monaleesa-3 trials, detailing significant overall survival improvements for different Kisqali combos in premenopausal and postmenopausal women, respectively.

In contrast, Ibrance’s pairing with AstraZeneca’s Faslodex didn't significantly outperform solo Faslodex at extending the lives of previously treated patients in the Paloma-3 trial. A smaller phase 2 trial dubbed Paloma-1 also failed to show a significant survival advantage for Ibrance’s use on top of Novartis’ aromatase inhibitor Femara. And the Pfizer drug also fell short as a postsurgical treatment in two trials in the adjuvant setting.

Still, Ibrance holds a seemingly unshakeable lead in market share. In the second quarter, Ibrance’s U.S. sales came in at $862 million, and its share in first-line new patient starts was strong at 73%, according to Pfizer. Kisqali brought in only $83 million in the same period.

According to SVB Leerink’s most recent tally of IQVIA data as of Sept. 10, Ibrance’s average new-to-brand scripts have been roughly stable at around 1,100 to 1,200 per week, while Kisqali’s were about 110. Eli Lilly’s Verzenio, probably thanks to its recent first-in-class adjuvant win, is seeing a growing number of new scripts, reaching 359 for an average of the last four weeks.

At ESMO 2021, Novartis unveiled new data from the Monaleesa-2 trial. It showed that adding Kisqali to Femara extended patients’ lives by one year, and the reduction in death risk reached 24%. Ibrance’s counterpart phase 3 trial, Paloma-2, has yet to report final overall survival data.

Gabriel Hortobagyi, M.D. of the MD Anderson Cancer Center, lead investigator of the Monaleesa-2 trial, has suggested that it may take a readout from the Paloma-2 trial to finally change doctors’ prescribing habits.

“If that [Paloma-2] trial is similarly positive to Monaleesa-2, then I think physicians will continue to prefer [Ibrance] simply because that’s their habit,” Hortobagyi said in an interview about Kisqali’s new data at ESMO 2021. “If that trial is negative, then I think … there will be an exodus from [Ibrance] to [Kisqali].”

https://www.fiercepharma.com/pharma/novartis-determined-to-dethrone-pfizer-to-launch-bold-kisqali-ibrance-head-to-head-trial

ESMO: Regeneron, Sanofi try again in lung cancer with Libtayo-chemo win. Merck worry?

 In the increasingly crowded market for immunotherapy in newly diagnosed non-small cell lung cancer, Regeneron and Sanofi hope to expand Libtayo into a broader population with a chemo combo regimen. And now, they've turned up competitive data that could pressure entrenched players Merck & Co. and Bristol Myers Squibb.

Libtayo, used on top of platinum doublet chemotherapy, reduced the risk of death by 29% over chemo alone in patients with previously untreated, advanced non-small cell lung cancer, according to data released at the European Society for Medical Oncology 2021 virtual congress.

The 29% improvement in patient survival may not seem so impressive, especially after Keytruda put up a massive 51% risk reduction. But a closer look at the results as offered by Regeneron and Sanofi could give rivals Merck and Bristol Myers pause.

The phase 3 Empower-Lung 3 trial included both squamous (43%) and nonsquamous (57%) NSCLC patients, all without actionable mutations. The Libtayo-chemo combo extended patient survival to a median 21.9 months, versus 13 months for the solo chemo group.

Difficult comparison looks good for Libtayo

By contrast, in Keytruda’s historic Keynote-189 trial, where the Merck PD-1 posted the 51% death risk reduction at an interim analysis, Keytruda and chemo prolonged survival for nonsquamous patients to about 22 months, whereas the control group recorded 10.6 months at final analysis. Then, in the Keynote-407 trial, squamous patients who took Keytruda and chemo lived a median 15.9 months, compared with 11.3 months for solo chemo, leading to a death risk reduction of 36% at interim.

Notice the difference? Libtayo’s overall survival showing across disease subtypes looked very similar to Keytruda’s at its best in the nonsquamous group, and the chemo arm appeared to have performed better in Empower-Lung 3 than in the Keytruda trials.

Regeneron entered the study expecting to see about 12 months of median overall survival for the chemo group, Israel Lowy, senior VP of translational and clinical sciences of oncology at Regeneron, told Fierce Pharma in an interview.

Still, one can't conclude that Libtayo is necessarily better than Keytruda, because there's an important difference between the studies: Empower-Lung 3 enrolled both advanced (stage 3) and metastatic (stage 4) patients, while the Keytruda trials only included stage 4 disease. In the Libtayo trial, 15% of patients had inoperable locally advanced disease not eligible for definitive chemoradiation.

But Lowy argued that including those earlier-stage patients didn’t push up Libtayo’s survival performance. According to him, advanced patients who aren’t eligible for surgery or chemoradiation have large tumor masses, so they don’t necessarily do better than patients with small metastases. He did notice, however, that relative to the nonsquamous population, the squamous group appeared to have done better for Libtayo compared with results seen in other trials.

A more straightforward comparison could be made with Opdivo, whose use alongside Bristol’s CTLA-4 inhibitor Yervoy and chemo snagged their front-line NSCLC approval last May.

In the CheckMate 9LA trial, the Opdivo-Yervoy-chemo cocktail cut patients’ risk of death by 31% over chemo. Patients with recurrent or stage 4 disease who took the Bristol regimen lived a median 14.1 months, versus 10.7 months for chemo at an interim analysis. The trial also recruited both squamous (31%) and nonsquamous (69%) subtypes.

One weak point for Libtayo-chemo lies in the PD-L1-negative group. In a subgroup analysis, patients with PD-L1 expression below 1%, who make up about one-third of the total trial population, performed similarly between the Libtayo regimen and solo chemo in terms of overall survival. Although the trial isn’t powered to statistically perform that analysis, the number could spell trouble for Libtayo potentially for PD-L1 nonexpressers. (Graphic for subgroup analysis can be found at the bottom of the article)

The Libtayo trial used a different companion diagnostic (SP263) than in the Keynote trials, Petra Rietschel, M.D., Ph.D., Regeneron’s executive director of immuno-oncology clinical development, wrote in a post on ESMO’s online platform during Libtayo’s presentation. “The difference in results might be due to SP263 being more sensitive and identifying a truly negative subset,” she wrote.

Cross-trial comparisons can be difficult, given different trial designs. But the new data at least showed Libtayo can be competitive in front-line NSCLC. With the 22-month overall survival data, Regeneron’s “sales reps will have plenty of firepower when detailing Libtayo as a viable anti-PD-1 option in 1L NSCLC,” Piper Sandler analyst Christopher Raymond wrote in an August note to investors.

It takes more than data

But as Evercore ISI analyst Josh Schimmer noted in an August report, “it will take more than clinical data alone to gain a foothold in 1L NSCLC.” He didn’t yet see a niche market for Libtayo but said he would keep an eye on the companies’ commercialization plans, including potential discounting.

Thanks to an FDA nod in February, Libtayo monotherapy is already allowed for front-line treatment of patients with locally advanced or metastatic NSCLC whose tumors have high levels of PD-L1 expression—50% or more. That population, according to Lowy, makes up about 30% of the NSCLC pool.

“We’re under no illusion that we’re suddenly going to take over the market,” Lowy said. “But we do believe that when one looks across different agents and you ask yourself the question of which one of these have delivered consistent results again and again with either monotherapy or chemo combination, we’re one of only two agents that have done that.”

Keytruda is the other PD-1/L1 that also succeeded as a monotherapy in PD-L1-high NSCLC.

Libtayo’s launch in lung cancer is progressing well, according to Regeneron. “Lung cancer thought leaders recognized Libtayo’s clinical differentiation, highlighting the rapid response rates and efficacy in patients with clinically stable brain metastases or high PD-L1 expression,” Regeneron’s commercial chief Marion McCourt said during a conference call in early August.

The Empower-Lung 3 trial also has a second part that pairs Libtayo with Yervoy and chemo in patients with PD-L1 expression at lower than 50%. Lowy said the company started the trial amid a general excitement over CTLA-4 inhibitors' potential boosting effect on PD-1 blockade.

But as data mature, “if you have a good anti-PD1 plus standard chemotherapy, it’s hard to convince yourself that combinations including CTLA-4 to date really do better than that, and it sometimes comes with the cost of additional toxicities associated with CTLA-4,” he said. So the company has stopped that cohort early, pending readout, and doesn’t plan to seek regulatory approvals with it, he added.

More competitors are on the horizon. AstraZeneca recently reported that its combination of Imfinzi, its investigational CTLA-4 agent tremelimumab and chemotherapy cut the risk of death by 23% over chemo alone in previously untreated stage 4 NSCLC.

Eli Lilly and its Chinese partner Innovent Biologics have an application under FDA review for China-approved PD-1 inhibitor Tyvyt in a combo with Lilly’s own Alimta and platinum chemo for newly diagnosed nonsquamous NSCLC.

Looming competition from potentially cheaper China-made drugs could shift the discussion around checkpoint inhibitors to choosing between “data-led” products like Keytruda and “fairly priced” newcomers, Bernstein analyst Rony Gal recently observed. In a letter to Regeneron CEO Len Schleifer, he called on the U.S. pharma to play the price card first to gain a firmer foothold for Libtayo.

https://www.fiercepharma.com/pharma/regeneron-sanofi-take-another-stab-at-lung-cancer-libtayo-chemo-combo-win-should-merck-worry

Surge in demand for monoclonal antibodies to treat COVID prompts Biden admin to new limits

 After urging providers for months to ramp up use of monoclonal antibody treatments that could prevent some people with COVID-19 from ending up in the hospital, the Biden administration says a "substantial" surge in demand from a handful of states has forced officials to impose new limits on orders for the drugs.

Seven states — Alabama, Florida, Texas, Mississippi, Tennessee, Georgia, and Louisiana — made up 70% of orders for monoclonal antibodies in recent weeks, according to the spokesperson for the Department of Health and Human Services, which manages supplies of the treatments purchased by the federal government. Overall, orders for the drugs since mid-July have climbed 20-fold.

Of those states, only Florida has fully vaccinated more than half of its total population, according to the Centers for Disease Control and Prevention. The others rank in the bottom 10 states for vaccinations nationwide. All seven rank among the top half of states with the highest rates of daily COVID-19 hospitalizations in recent weeks.

"Given this reality, we must work to ensure our supply of these life-saving therapies remains available for all states and territories, not just some," said the spokesperson. Instead of providers ordering the drugs directly from the federal government's supplier, AmeriSourceBergen, doses of monoclonal antibodies are now being allocated by HHS to state health departments, "based on COVID-19 case burden" and demand for the drugs.

States will be responsible for deciding how to distribute the doses of Regeneron's REGEN-COV and Eli Lilly's combination bamlanavimab and etesevimab to doctors, clinics, and pharmacies within their borders.

But some states claim they were blindsided by the administration's change, and say the new allocations will leave some providers empty-handed in the face of a surge of cases fueled by the highly-contagious Delta variant.

"We're responsible not only for sourcing our sites, which we're happy to do, but any infusion center, any provider, any hospital will have to come through the state," Florida Governor Ron DeSantis said at a press conference Thursday.

"To just spring this on us starting next week, we're going to have to do that. There's going to be a huge disruption and patients are going to suffer as a result of this," the governor said.

A spokesperson for DeSantis, Christina Pushaw, cited emails from federal health officials to the state's health department in recent weeks that she said "did not provide any indication of any upcoming limitation to supply." Pushaw said the state was now projecting a 41,050 deficit in doses of the monoclonal antibody treatments next week, under the federal government's new allocations.

In Texas, state health officials said that the Biden administration had warned them "national supply has considerably decreased.". The state is now working to stand up a system to handle orders for the drugs "as quickly as possible."

"We just don't know what the supply will be over the long term and can't predict what the effect will be," said Douglas Loveday, a spokesperson for the Texas Department of State Health Services.

The Biden administration spokesperson rejected accusations that the move came as a surprise, citing calls last week with state health officials to explain the change.

"This was not just like we flipped the switch and all of a sudden it happened. That's not how this works. It's never worked that way," said the spokesperson.

The new caps on orders also come as the U.S. has struck more deals to boost supplies of the antibody treatments, after demand had initially plummeted amid falling cases earlier this year.

Eli Lilly announced Wednesday that the U.S. government had purchased an additional 388,000 doses of a part of its combination antibody treatment. Regeneron said Tuesday that the federal government had bought 1.4 million more doses of their treatment.

The Food and Drug Administration also moved Thursday to amend its emergency use authorization for Eli Lilly's drug, allowing for it to be used as "post-exposure prophylaxis" in some adults and children at high risk of severe COVID-19 — meaning it could be given as a preventive measure after someone was exposed to the virus, even if they haven't tested positive. Regeneron's monoclonal antibody drug was previously authorized for this use in August.

Federal health officials said they had so far not seen widespread stockpiling or misuse of the drugs. Both the FDA and HHS had urged providers to ensure that the drugs were not being used as a "substitute for vaccination." 

However, before returning to the current allocation process — similar to a system the federal government had used to ration monoclonal antibodies to states earlier in the pandemic — the Biden administration had first said earlier this month that it would be "reviewing all orders for alignment with utilization."

But that decision had also frustrated providers, multiple state health officials said, delaying shipments and creating uncertainty for health systems trying to schedule patients in the short window when the drugs can be used before they may need to be hospitalized.

"On Monday morning, one of our hospitals serving as an infusion center alerted us that last week they received only 25 percent of what they ordered and that their order for this week was still under review," said Shareese DeLeaver-Churchill, a spokesperson for Maryland's Governor Larry Hogan.

Hogan said Tuesday he raised the issue on the White House's weekly call with governors, decrying it as "another example of confusing and conflicting guidance coming from the federal government."

"The immediate concern is that while we have more than 30 facilities statewide that offer these treatments, some serve as the only hub in their area so these changes may dramatically affect access to care," said DeLeaver-Churchill.

https://www.cbsnews.com/news/monoclonal-antibodies-covid-19-treatment-florida-texas-states/

ESMO: Mirati pulls away from Amgen in colorectal cancer with rival KRAS drug

 Mirati Therapeutics has spent 2021 watching Amgen blast past it to win the race to bring a KRAS drug to market in lung cancer. Yet, with Amgen’s Lumakras underwhelming in colorectal cancer, Mirati still has a shot at carving out a niche.

The small biotech rocked up to this year’s European Society of Medical Oncology (ESMO) congress with data to make its case. 

Amgen previously linked Lumakras to an overall response rate (ORR) of 7% in colorectal cancer, well below the level that won it approval in non-small cell lung cancer. Mirati’s adagrasib was performing better than Lumakras at its previous data drop, with the usual caveats about cross-trial comparisons, but at 17% the ORR still had ample room for improvement. The biotech used a late-breaker at ESMO to share the latest data.

As of May 25, the response rate in the 45 evaluable patients who received adagrasib as a single agent stood at 22%. The 10 patients listed as responders include one person with an unconfirmed partial response who remains on study. Absent that unconfirmed response, the ORR would be 20%. Median duration of response was 4.2 months.

Mirati has previously said (PDF) an ORR of 20% and median duration of four months are the threshold to potentially seek accelerated approval of adagrasib in colorectal cancer. The data in the ESMO abstract put it over that bar—but only by a whisker.

A small percentage of colorectal cancer patients have KRAS G12C mutations, leading Mirati to put the size of the patient population across the U.S. and Europe at around 20,000 people. That makes for a far smaller market than non-small cell lung cancer but still represents an opportunity that may be wide open to Mirati given Amgen’s struggles in the indication.

Mirati also used ESMO to share an update on patients who have received adagrasib in combination with cetuximab, the drug also known as Erbitux. The response rate in the 28 evaluable patients who received the combination was 43%, including two people with unconfirmed partial responses. After the July 9 data cutoff, follow-up scans confirmed one response but the other patient progressed. 

The findings offer encouragement for Mirati as it enrolls second-line colorectal cancer patients in a phase 3 trial of adagrasib in combination with cetuximab. Mirati has penciled in a September 2023 primary completion date for the 420-subject randomized clinical trial.

Amgen touted its own combination therapy data at ESMO but its numbers still lag those posted by Mirati. The response rate in colorectal cancer patients who received Lumakras in combination with EGFR inhibitor Vectibix was 27%, compared to 10% in the people who got the KRAS drug alone.

https://www.fiercebiotech.com/biotech/esmo-mirati-pulls-away-from-amgen-colorectal-cancer-updated-data-kras-drug

Key data on U.S. Johnson & Johnson, Moderna COVID booster shots ‘weeks away': Fauci

 

A U.S. Food and Drug Administration advisory panel on Friday recommended a third shot of the two-dose Pfizer/BioNTech vaccine for people age 65 and older or at high risk of severe COVID-19, but declined to endorse boosters for the wider population.

Data needed to determine the advisability of booster shots of the Moderna Inc and Johnson & Johnson COVID-19 vaccines is just weeks away, President Joe Biden’s chief medical adviser said on Sunday, as officials signaled they expected boosters would be recommended for a broad swath of Americans.

U.S. health regulators already have begun to consider a third dose of the Pfizer/BioNTech vaccine.

A U.S. Food and Drug Administration advisory panel on Friday recommended a third shot of the two-dose Pfizer/BioNTech vaccine for people age 65 and older or at high risk of severe COVID-19, but declined to endorse boosters for the wider population.

People who have received the two-dose Moderna vaccine or one-dose J&J vaccine are still awaiting guidance on possible booster shots.

“The actual data that we’ll get (on) that third shot for the Moderna and second shot for the J&J is literally a couple to a few weeks away,” Anthony Fauci, the U.S. government’s top infectious disease expert and a Biden adviser, told NBC’s “Meet the Press” program.

“We’re working on that right now to get the data to the FDA so they can examine it and make a determination about the boosters for those people,” Fauci added.

More data may also show a broader need for booster shots across the general U.S. population, Fauci said.

The United States leads the world in COVID-19 cases and deaths. Nearly 676,000 people have died during the pandemic in the United States, figures compiled by Reuters showed.

An increase in U.S. cases and deaths in recent months has been most acute in areas with lower vaccination rates even as federal health officials implore vaccine holdouts to get their shots.

The FDA advisers declined to recommend a third dose of the Pfizer/BioNTech vaccine for people age 16 and older who received their second shot at least six months earlier. Though the FDA is not bound by the panel’s recommendation, it will take it into consideration when deciding on whether to recommend a third
round of shots.

“This is not the end of the story,” Fauci told CNN’s “State of the Union” program.

“They’re going to continue to look at this, literally in real time,” Fauci added.Biden announced in August the government’s intention to roll out booster shots for people age 16 and older, pending approval by the FDA and Centers for Disease Control and Prevention experts.

The FDA’s decision-making process does not negate the White House’s position favoring boosters, Fauci said.

Fauci urged that people beyond the group for which the FDA panel recommended boosters wait to get them until formal approval is given.

Francis Collins, director of the U.S. National Institutes of Health, said on the “Fox News Sunday” program that he expects it would “become clear over the next few weeks that administration of boosters may need to be enlarged,” citing existing data from the United States and Israel indicating waning vaccine effectiveness over time.

https://www.financialexpress.com/lifestyle/health/key-data-on-u-s-johnson-johnson-moderna-covid-19-booster-shots-weeks-away-says-fauci/2333487/