People Are Getting Moderna 'Boosters' Anyway

 Several sources have told MedPage Today that they've received a "booster" shot of Moderna, even though the vaccine isn't yet authorized for this indication.

These are people who don't fit the specific criteria for being immunocompromised that would qualify them for a third dose of the vaccine. Some of them are over 65 but didn't get their primary series with Pfizer. The majority got their shots at a pharmacy, not in a doctor's office.

"We both have two Moderna shots and a Moderna booster, figuring that even if the booster isn't approved yet, it can't hurt," said one source who is over 65 but not immunocompromised, speaking of himself and his wife. "Our family doc told us to get one ASAP."

While sources didn't share exactly how they got their Moderna "boosters," the immunocompromised are only required to self-attest to their condition, and don't need to bring a doctor's note to their pharmacies in order to get third doses, according to the CDC.

People have long been pursuing boosters or third shots of COVID vaccines, even before the FDA authorized a third dose of either vaccine for the immunocompromised in August, or Pfizer boosters for certain groups earlier this month.

In early August, for instance, ABC News reported on a leaked CDC memo that found about 1.1 million people had already received an unauthorized third dose of either vaccine -- and acknowledged that number was likely an undercount.

It's possible that number included a large proportion of immunocompromised patients seeking a third dose, but others may have simply been concerned about waning immunity in the face of the Delta variant.

One caution about forging ahead with a Moderna booster is that when the company submitted data to FDA for review, it focused on a 50-mcg shot, rather than the 100-mcg doses given for the first and second shots. It's not clear if the lower dose would carry fewer side effects, as the second Moderna shot garnered a reputation for packing a punch.

In addition to the possible differences in dose with any Moderna booster that's authorized in the future, there are also some differences with the third dose for the immunocompromised. That third shot is authorized at the 100-mcg dose at least 28 days after the initial two-dose series. Any Moderna booster would likely come 6 months after the primary two-dose series.

MedPage Today reached out to CVS and Walgreens to clarify their policies on Moderna boosters and third doses.

A Walgreens spokesperson said it's offering Pfizer boosters to eligible individuals, but Moderna "is not currently available as a booster, and we will continue to follow additional guidance from the FDA and CDC." The spokesperson also acknowledged providing third doses of either mRNA vaccine to immunocompromised individuals.

A CVS spokesperson said the company began administering Pfizer boosters last week, and that "more data on the effectiveness and safety of Moderna and Johnson & Johnson (Janssen) booster shots are expected in the coming weeks."

The CVS spokesperson also noted the availability of Pfizer and Moderna third shots for the immunocompromised, highlighting CDC guidance that "if the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product (Moderna or Pfizer) may be administered."

The back-and-forth on boosters has led to confusion about eligibility. At this point, third doses of both mRNA vaccines are authorized 28 days after the primary series for those with very specific immunocompromising conditions as outlined by CDC's Advisory Committee on Immunization Practices (including solid-organ transplant recipients, those undergoing cancer treatment, and those on immune-suppressing drugs such as alkylating agents, antimetabolites, and tumor necrosis factor blockers). People with chronic conditions like heart disease or diabetes are not considered to be a part of this group.

Those who received a primary two-dose series with Pfizer are eligible for a booster shot (at the same dose as the original shots) at least 6 months after their second dose if they're 65 and older; if they're 18 to 64 and at high risk of having severe COVID; or if they're 18 to 64 and at high risk of contracting COVID-19 due to occupational exposure.

Given the confusion and "booster envy," President Biden has attempted to reassure Americans who are playing by the rules that they'll be okay.

"If you don't qualify for the booster, or you got the Moderna and Johnson & Johnson vaccines: if you're fully vaccinated, you're highly protected from severe illness even if you get COVID-19," Biden tweeted earlier this week.

https://www.medpagetoday.com/special-reports/exclusives/94789

FDA won't extend shelf life of J&J Covid vax, may extend life of Moderna shots

 The government will not extend the shelf life of hundreds of thousands of unused Johnson & Johnson Covid vaccine doses, but may soon extend the life of millions of Moderna vaccine doses, according to an internal email obtained by NBC News.

In an email sent to state health officials and health-care providers Friday morning, the Centers for Disease Control said the Food and Drug Administration will not further extend the life of Johnson & Johnson vaccines sitting on states' shelves across the country, leading to the potential waste of hundreds of thousands of doses.

The CDC told officials and health-care providers to check their Covid vaccine inventories for "many lots" of expiring Johnson & Johnson vaccine doses and told them that despite previous shelf-life extensions for Johnson & Johnson doses, the FDA will not take further action.

The email says, "There will be no more extension."

In the same message, the CDC notified states that the FDA will likely extend the expiration date of millions of doses of Moderna vaccine. Two sources who did not want to be identified told NBC News that an extension for Moderna would likely add up to two months to the life of vaccine doses.

The FDA referred inquiries to the companies and declined comment on the email. Moderna declined to comment. Johnson & Johnson did not immediately respond to a request for comment.

On July 28, the FDA extended the shelf life of the J&J doses to six months from manufacture. Doses have been rolling out to states in batches since the vaccine was approved in late February. Unused doses sent to states in April or earlier should expire soon.

It's unclear how many J&J doses could be wasted but the federal government has shipped 22 million doses to states and only 15 million have been administered so far, according to data from the CDC's website.

West Virginia Covid czar Dr. Clay Marsh said the state had recently disposed of 9,000 J&J doses. Virginia health officials told NBC News they had 26,936 J&J doses on the shelves, and Washington state had 57,883 doses as of Sept. 27. Arkansas has 11,284, Rhode Island has 6,825 as of this morning according to state officials.

Most states stopped ordering new J&J shots a few months ago and demand for the shot has not been strong, according to state health officials.

It's possible that doses on the shelves could be used as booster shots but only if the company files for authorization quickly and the FDA takes action by providing emergency use authorization for a J&J booster.

As of Sept. 21, Johnson & Johnson said it had provided all available booster data to the FDA but a formal filing has still not happened. In order for the booster approval to happen, the company would have to file, FDA officials would have to review the data and the CDC advisory committee would need to meet to weigh in.

Late Friday afternoon, the FDA announced an agency advisory committee would meet in mid-October to discuss boosters for both the J&J and Moderna vaccines.

https://www.nbcnews.com/health/health-news/fda-won-t-extend-shelf-life-j-j-covid-vaccine-n1280579

CTI BioPharma Misses Topline Endpoint with Covid-19 Treatment

  PRE-VENT amended to a Phase 2 study due to shifting COVID-19 treatment landscape -

- PRE-VENT did not achieve pre-defined statistical significance for the primary endpoint of proportion of patients who progressed to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or died -

CTI BioPharma Corp. (Nasdaq: CTIC) today announced topline results from the PRE-VENT trial (NCT04404361) of pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, compared pacritinib/standard of care versus placebo/standard of care in hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial was the proportion of patients who progressed to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or died by Day 28. The study was recently amended to a Phase 2 design due to the availability of COVID-19 vaccines and an evolving COVID-19 environment.

The final PRE-VENT analysis was conducted following the randomization of 200 patients. In patients with severe COVID-19 treated with pacritinib/standard of care, compared to placebo/standard of care, a statistically significant improvement in the primary endpoint of progression to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or death by Day 28 was not demonstrated (26.3% vs. 24.8% [OR: 1.01 (95% CI: 0.51-1.99)], P=0.98).

Pacritinib was generally well-tolerated by patients with severe COVID-19, with lower rates of grade 3+ events and serious adverse events being reported in patients treated with pacritinib/standard of care compared to placebo/standard of care (29.2% vs. 40.6% and 20.8% vs. 32.7%, respectively). The most common adverse events comparing pacritinib/standard of care to placebo/standard of care were increased alanine aminotransferase (15.6% vs. 16.8%), anemia (12.5% vs. 17.8%), bradycardia (15.6% vs. 10.9%), constipation (12.5% vs. 12.9%), hypokalemia (12.5% vs. 12.9%), and hyperkalemia (9.4% vs. 10.9%).

https://finance.yahoo.com/news/cti-biopharma-announces-topline-data-200500807.html

FDA Panel Meetings on Emergency Use Authorization for Boosters, COVID Vaccines for Young Children

 Today, the U.S. Food and Drug Administration is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.

VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters 

On Oct. 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster). 

“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic. It’s critical that as many eligible individuals as possible get vaccinated as soon as possible. Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19. The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

On Oct. 14, the committee will discuss an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older. 

On Oct. 15, the VRBPAC will discuss amending the emergency use authorization of Johnson and Johnson’s Janssen COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older. 

Additionally, on Oct. 15, the committee will hear a presentation from the National Institute of Health’s National Institute of Allergy and Infectious Diseases on the heterologous use of booster doses following the primary series of the three currently authorized or approved COVID-19 vaccines. 
   
During the meeting, the committee will hear presentations from the companies on the data for their respective vaccines. The FDA will also present its own analyses of each of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an opportunity to provide comments.

VRBPAC Meeting on Pfizer Data on Its COVID-19 Vaccine for Children 5-11

The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on Oct. 26 to inform the agency’s decision-making.

“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Acting FDA Commissioner Janet Woodcock, M.D. 

The FDA intends to make background materials for both VRBPAC meetings available to the public, including the meeting agendas and committee rosters, no later than two business days before each meeting. 

The FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page (Oct. 14 meeting linkExternal Link Disclaimer; Oct. 15 meeting linkExternal Link Disclaimer; Oct. 26 meeting linkExternal Link Disclaimer), which will be viewable on the agency’s FacebookExternal Link Disclaimer and TwitterExternal Link Disclaimer channels; the meetings will also be webcast from the FDA website.

https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meetings-discuss-emergency-use-authorization-booster-doses-and-covid-19

FDA approval tracker: September

 While there were FDA setbacks for Calliditas and Verrica last month there were also a couple of early oncology approvals. One such win was for Tivdak, Seagen/Genmab’s treatment for recurrent or metastatic cervical cancer. However, expected sales of Tivdak could be hit by an unexpected black box warning regarding ocular toxicity. An early approval for Takeda’s Exkivity also came with safety implications. The oral therapy, used to treat lung cancer driven by EGFR exon 20 insertions, has a black box warning for QTc prolongation. J&J’s competing project Rybrevant does not come with a warning, but is less convenient as it is an infused antibody. Separately, Takeda investors are still holding out for FDA news on Eohilia after the FDA's action date was missed in April. Takeda says Eohilia could become the first treatment for eosinophilia oesophagitis, but with a filing for Sanofi/Regeneron’s Dupixent expected next year Takeda will want the regulators to hurry.

Notable first-time US approval decisions in September
Project	Company	Indication(s)	2026e sales by indication ($m)	Outcome
Qulipta (atogepant)	Abbvie	Episodic migraine prevention	954	Approved
Tivdak (tisotumab vedotin)	Seagen/Genmab	Previously treated recurrent or metastatic cervical cancer	629*	Accelerated approval (over 2 weeks early)
Nefecon	Calliditas	IgA nephropathy	629**	Extended to Dec 15
Exkivity (moborcertinib)	Takeda	EGFR exon 20 Insertion+ NSCLC	436	Accelerated approved (over a month early)
Livmarli (maralixibat)	Mirum	Cholestatic pruritus in Alagille syndrome	432	Approved
VP-102	Verrica	Molluscum contagiosum	271*	Second CRL (deficiencies at contract manufacturer)
Eohilia (TAK-721)	Takeda	Eosinophilic esophagitis	187	No decision yet (April Pdufa missed)
Illuccix	Telix	Prostate cancer imaging	42	Extended to December 23
Reltecimod	Atox Bio	Resolution of organ dysfunction in necrotising soft tissue infections	-	Supposed to have been Sep 30, no news released
Epsolay	Sol-Gel	Papulopustular rosacea	-	No decision yet (delayed in Apr)
*Sales by indication not split out, **includes undisclosed partner sales. Source: Evaluate Pharma & company releases

 

 

Supplementary and other notable approval decisions in September
Product	Company	Indication (clinical trial)	Outcome
AVT02 (Humira biosimilar)	Alvotech/Teva	Inflammatory conditions, PK study AVT02-GL-101, efficacy study AVT02-GL-301	Delayed (facility inspection)
Repatha	Amgen	Paediatric patients with heterozygous familial hypercholesterolemia (Hauser-RCT)	Approved
Invega Hafyera (Paliperidone palmitate 6-month, PP6M)	J&J	Adults with schizophrenia (Route 6)	Approved
INP104/ Trudhesa	Impel	505(b)(2) application acute treatment of migraine (dihydroergotamine mesylate with olfactory delivery)	Approved
Brukinsa	Beigene	Marginal zone lymphoma who have received at least one prior anti-CD20-based therapy (Magnolia, Ph1/2)	Approved
Brukinsa	Beigene	Waldenström’s macroglobulinemia (Aspen)	Approved
Opzelura (ruxolitinib cream)	Incyte	Atopic dermatitis (TruE-AD1, TruE-AD2)	Approved
Jakafi	Incyte/Novartis	Paediatric patients with steroid-refractory GvHD (Reach3)	Approved
Byooviz (Lucentis biosimilar)	Biogen/ Samsung Bioepis	Wet AMD, myopic choroidal neovascularisation and macular oedema following retinal vein occlusion	Approved
Erbitux + Braftovi	Lilly/Pfizer	Adult patients with metastatic colorectal cancer with a BRAF V600E mutation (Beacon CRC)	Approved
Source: Evaluate Pharma, company releases & clinicaltrials.gov https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-september-0

Unexpected win opens the way to an oral Covid antiviral

 If Merck’s acquisition of Acceleron yesterday had been widely expected the same cannot be said of today’s positive results for the group’s Covid-19 antivital molnupiravir. The Ridgeback Biotherapeutics-partnered project had already failed in hospitalised subjects, so today’s pivotal study success in outpatients is a major shot in the arm.

With analysts hailing the data, from a planned interim analysis of the Move-Out trial, a “game changer”, Merck opened up 10% this morning, equivalent to a market cap increase of almost $20bn. The success comes in contrast to the lacklustre performance of some other Covid treatments, and marks a turnaround for molnupiravir, a repurposed flu antiviral.

As Vantage Analysis had pointed out, the pipeline for oral antivirals for Covid-19 was looking thin. Merck itself, in addition to scrapping part of its molnupiravir work, had abandoned MK-7110, a separate project it had gained via Oncoimmune, in hospitalised patients after an FDA request for more data made it unviable for the coronavirus in the short term.

Oral game-changer

Today the story is quite different, however, and molnupiravir's oral dosing is the main reason why this is being hailed as such a success. The convenience of a drug that can be taken as a tablet, at home, within five days of Covid-19 symptoms starting, cannot be understated.

Not only that, but Move-Out has shown a 50% reduction in risk of hospitalisation or death, Merck said today, hitting a p value of 0.0012 at an interim analysis triggered by the evaluation of the first 775 of a total 1,550 mild-to-moderate Covid-19 patients. A decision to stop recruitment based on compelling interim efficacy was taken on August 5, Merck said, with over 90% of the total enrolled, and full analysis is forthcoming.

The only US-approved antiviral is Gilead’s Veklury, but this has the disadvantage of IV dosing. Moreover, its clinical backing is somewhat unconvincing: two trials showed an improved time to recovery versus placebo but a third did not, and no decrease in mortality has been demonstrated with Veklury.

Remaining existing competition in the treatment setting comes from antibodies. Regeneron’s Regen-Cov, a combo of the MAbs casirivimab and imdevimab, and Lilly/Abcellera’s bamlanivimab plus etesevimab are both available under emergency use authorisation for post-exposure prophylaxis, and both have demonstrated reductions in hospitalisation or death.

However, like Veklury both have to be injected. Another MAb combo, Astrazeneca’s AZD7442, does have the convenience of intramuscular dosing and a long half life, but failed in post-exposure prophylaxis. It did succeed in pre-exposure prophylaxis, but clearly this is a separate market from the treatment setting Merck is now targeting.

Oral antivirals for treating Covid-19
Project	Company	Setting	Note
Molnupiravir	Merck & Co/Ridgeback	Ph3 in outpatients succeeded (Move-Out, NCT04575597); Ph2/3 in hospitalised pts terminated (Move-In; NCT04575584)	Repurposed flu antiviral
AT-527	Roche/Atea	Ph3 in outpatients ends Nov 2021 (Morningsky, NCT04889040)	Repurposed hep C antiviral
PF-07321332	Pfizer	Ph3 in low-risk outpatients ends Oct 2021 (NCT05011513) Ph3 in high-risk outpatients ends Nov 2021 (NCT04960202)	Ritonavir combo
Favipiravir	Appili	Ph3 in outpatients ends Sep 2021 (Preseco, NCT04600895)	Repurposed flu antiviral
Upamostat	Redhill Biopharma	Ph2/3 in outpatients ends Sep 2022 (NCT04723537)	Repurposed oncology project (Mesupron)
Source: Evaluate Pharma & clinicaltrials.gov.

The Move-Out data have yet to be scrutinised in full, but the interim readout breaks down into a 39% reduction in day-29 hospitalisation, and zero deaths on molnupiravir versus eight on placebo. It will be important for these data to hold up at final analysis.

Other reasons for optimism is that Merck said the results were consistent across the viral variants Gamma, Delta and Mu in patients where sequencing had been carried out. Logically, Merck intends to file for US emergency use authorisation.

In terms of competition the next dataset to look out for will come from Roche/Atea’s AT-527, Pfizer’s PF-07321332 and Appili's favipiravir, but beyond that the oral antiviral space looks bleak. Illustrating the game-changing nature of an oral Covid-19 treatment, Atea this morning traded up 20%, while the MAb players Regeneron and Abcellera were off 7% and 8% respectively.

A final point to consider is why this took Merck so long; Move-Out had begun last October, yet with the Covid-19 pandemic raging in many of the countries in which the trial was run it took 10 months to generate 775 patients’ worth of 29-day data. Perhaps this illustrates just how low hopes had been.

https://www.evaluate.com/vantage/articles/news/trial-results/unexpected-win-opens-way-oral-covid-antiviral

Merck pill seen as 'huge advance,' raises hope of preventing COVID-19 deaths

 Co will seek U.S. approval for pill as soon as possible

* If approved, would be 1st oral antiviral COVID-19 drug

* Merck shares rally, some vaccine makers fall

* U.S govt to buy 1.7 mln courses at $700 each (Adds White House official, details on potential side effects, updates shares)

An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.

If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Merck and partner Ridgeback Biotherapeutics said they plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.

“An oral antiviral that can impact hospitalization risk to such a degree would be game changing,” said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.

Current treatment options include Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.

“This is going to change the dialogue around how to manage COVID-19,” Merck Chief Executive Robert Davis told Reuters.

Existing treatments are “cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that,” Adalja added.

The results from the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study is being stopped early at the recommendation of outside monitors.

Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up more than 21% on the news.

Shares of COVID-19 vaccine makers here Moderna Inc were off more than 10%, while Pfizer was down less than 1%.

Jefferies analyst Michael Yee said investors believe “people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID.”

Pfizer and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill here for COVID-19. For now, only antibody cocktails that have to be given intravenously are approved for non-hospitalized patients.

White House COVID-19 response coordinator Jeff Zients said on Friday that molnupiravir is “a potential additional tool... to protect people from the worst outcomes of COVID,” but added that vaccination “remains far and away, our best tool against COVID-19.”

A planned interim analysis of 775 patients in Merck’s study looked at hospitalizations or deaths among people at risk for severe disease. It found that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after treatment. That compared with a hospitalization rate of 14.1% for placebo patients. There were also eight deaths in the placebo group.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.

‘A HUGE ADVANCE’

Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world, 700,000 in the United States.

“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck has said similar studies of molnupiravir – for longer and at higher doses than used in humans – indicate that the drug does not affect mammalian DNA.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants here of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.

It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.

The U.S. drugmaker said it expects to produce 10 million courses of the treatment by the end of 2021.

The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.

Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck’s research labs, said, “they are going to try to work with alacrity on this.”

https://www.reuters.com/article/health-coronavirus-merck-treatment/update-4-merck-pill-seen-as-huge-advance-raises-hope-of-preventing-covid-19-deaths-idUSL1N2QX0QJ