COVID-19 stats and research news - until Nov. 15, 2021

[MarzNC]

Comirnaty didn’t become an approved thing until this August, but ya already knew that fact, allegedly.

Second shot on March 6

Doesn't matter. Point is that the six months timeframe for a booster is based on when someone got their second shot.

Besides the booster decision is still under Emergency Use Authorization, not the full approval completed in August.

 

[tirolski]

Doesn't matter. Point is that the six months timeframe for a booster is based on when someone got their second shot.

Besides the booster decision is still under Emergency Use Authorization, not the full approval completed in August.

Comirnaty doesn’t legally operate under EUA rules.
It’s a commercial product which have different rules.

It’s a few months old, the fifth point is interesting.

What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)? - Bill of Health

A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.

blog.petrieflom.law.harvard.edu

 

[MarzNC]

It’s a few months old, the fifth point is interesting.

What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)? - Bill of Health

A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.

blog.petrieflom.law.harvard.edu

Good read. I found the fourth and fifth points interesting.

Definitely a different situation for a BLA for a vaccine candidate than an NDA for a drug candidate. More than just the fact that tens of thousands of subjects need to be enrolled for a Phase 3 vaccine clinical trial, while a NDA can be submitted based on two solid clinical trials involving a few hundred subjects. What is similar is that the primary trial(s) must be done in the USA. Any other research data involving human subjects must be combined and included in the Integrated Summary of Safety.

" . . .
Fourth, an approved BLA likely would make it harder for new vaccines to receive EUAs. The FDA has statutory authority to grant an EUA only if “there is no adequate, approved, and available alternative,” so if Pfizer’s or Moderna’s approvals are granted and are deemed both “adequate” and sufficiently “available” for the intended populations, an EUA couldn’t be granted. To be sure, there are strong arguments (for instance) that the existing mRNA vaccines may not be sufficiently “available” for particular populations when compared to a product like J&J’s, a one-dose vaccine without the mRNA vaccines’ particular storage needs. But the agency has already taken steps toward limiting future EUA requests, suggesting that these factors may be more difficult to satisfy in the future.

Fifth, EUAs last only as long as the public health emergency that prompted them. Although COVID-19 continues to devastate countries around the world, the pandemic appears to be winding down in the United States as vaccination becomes more widespread. Approval will allow manufacturers to continue marketing their vaccines even after the officially declared emergency ends. Relatedly, manufacturers that receive full approval of their vaccines will have an easier time receiving approval for post-pandemic boosters to address new variants if COVID-19 becomes endemic.
. . ."

 

[tirolski]

Here’s the CDC advisory booster meeting.
Enjoy.

 

[MarzNC]

Lots of people are probably watching what's happening in New York City in terms of vaccination requirement deadlines that are coming up soon.

September 27, 2021

As New York's COVID vaccine mandate for health workers loomed, thousands got shots to keep jobs

Thousands of nursing home workers scrambled to get COVID-19 vaccines in the days before New York's vaccine mandate took effect Monday.

www.usatoday.com

"ALBANY, N.Y. — In the final push before New York state's vaccine mandate for medical workers took effect Monday, at least 8,700 nursing home workers chose to get the COVID-19 vaccine to avoid losing their jobs, state data showed.

The percentage of nursing home staff receiving at least one dose of COVID-19 increased to 89% as of Sunday, up from 83% on Wednesday.

Still, that means about 16,000 of the 145,000 total nursing home workers statewide had yet to comply with the vaccine mandate, which has some nursing home operators concerned about staff shortages negatively impacting care for residents.

As for hospitals, the number of workers who waited to the 11th hour to comply with the vaccine mandate remains unclear, as the state-run database tracking the effort has not been updated since Wednesday.

Hospitals reported 84% of their roughly 450,000 workers were vaccinated as of Wednesday, up from 81% on Sept. 15. That left the future employment of about 72,000 hospital workers unclear, though many hospitals policies appeared to allow workers to get vaccinated through the end of Monday in order to retain their jobs.
. . ."

 

[MarzNC]

Lots of people are probably watching what's happening in New York City in terms of vaccination requirement deadlines that are coming up soon.

As often happens, there were people who waited until the last minute. Most hospitals in NYC probably have 90-95% of their staff vaccinated with at least one dose. That matches up with the vax rate that college faculty and staff are reaching at universities that have required vaccination since late August, if not earlier.

September 28, 2021

Health care workers in New York rush to get vaccinated, averting a staffing crisis.

www.nytimes.com

"
Thousands of health care workers in New York got inoculated against Covid-19 ahead of Monday’s deadline, helping the state avoid a worst-case scenario of staffing shortages at hospitals and nursing homes.

Health officials across the state reported that employees had rushed to get vaccinated before Monday, avoiding being suspended or getting fired. New York has 600,000 health care workers.

Statewide, the vaccination rate for hospital employees rose by Monday night to 92 percent of workers having received at least one dose, according to preliminary data from the governor’s office. The rate for nursing homes also jumped to 92 percent on Monday, from 84 percent five days earlier.
. . ."

 

[tirolski]

Good news.

Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study -

At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit...

www.merck.com

 

[MarzNC]

Good news.

Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study -

At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit...

www.merck.com

Fairly significant that given the interim analysis, recruitment for the Phase 3 study is being stopped. Since it's a placebo controlled trial, would become an ethical issue to continue to randomize people into the placebo group. The subjects being enrolled must be "at risk," so that probably means unvaccinated. There were already over 300 subjects in both groups, which is a reasonable number for many new drug clinical trials. The early termination would have been part of the statistical analysis plan in terms of when doing an interim analysis for efficacy made sense in order to have enough statistical power to detect a significant difference between placebo and molnupiravir.

Assuming molnupiravir gets emergency approval fairly soon, it will be that much more important that people with symptoms or suspect close contact get tested ASAP. The drug is meant to be taken early in a COVID-19 infection before someone needs to be hospitalized.

"KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.
. . ."

September 2, 2021

Merck and Ridgeback begin Phase III trial of molnupiravir for Covid-19

Merck and Ridgeback Biotherapeutics have commenced a Phase III MOVe-AHEAD trial of their oral drug, molnupiravir, to prevent Covid-19.

www.clinicaltrialsarena.com

" . . .
The trial plans to enrol nearly 1,332 adult subjects, who will be categorised to receive an oral dose of either 800mg molnupiravir or placebo every 12 hours for five days.

People living in the same household with someone who has tested positive for Covid-19, at least one related symptom and has not had signs or symptoms for more than five days will be eligible for the trial.

The percentage of subjects with Covid-19 through day 14, an adverse event and discontinuation of study intervention because of an adverse event, will be the trial’s primary goals.
. . ."

 

[tirolski]

Fairly significant that given the interim analysis, recruitment for the Phase 3 study is being stopped. Since it's a placebo controlled trial, would become an ethical issue to continue to randomize people into the placebo group.

Yup.

The subjects being enrolled must be "at risk," so that probably means unvaccinated.

Criteria
Inclusion Criteria:

• Lives in a household with an index case where the index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have 1) a first positive SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant, and 2) at least 1 symptom attributable to COVID-19 (e.g., fever, difficulty breathing)
• Does not have confirmed or suspected COVID-19
• Is willing and able to take oral medication
• Is male and willing to be abstinent from heterosexual intercourse or use acceptable contraception during the study and for ≥4 days after the last dose of study intervention
• Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse

Exclusion Criteria:

• Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) or has a prior positive test results for anti-SARS-CoV-2 antibodies
• Is on dialysis or has renal impairment
• Has either of the following: 1) human immunodeficiency virus (HIV) with a recent viral load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome (AIDS)-defining illness; or 2) neutrophilic granulocyte absolute count <500/mm^3
• Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma; aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
• Has a low platelet count or received a platelet transfusion within 5 days prior to randomization
• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
• Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to participants with conditions that could limit gastrointestinal absorption of capsule contents
• Has received, is taking, or is anticipated to require any prohibited therapies
• Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization
• Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics
• Has more than 1 individual currently (assessed at the time of consent), or within the last month, living in the household with confirmed or suspected COVID-19
• Is living in a household with >10 people

Emphasis added.

 

[MarzNC]

Exclusion Criteria: . . .

• Has received a COVID-19 vaccination with the first dose ≥7 days prior to randomization

So that means someone who just got their first dose, and then finds out within a week they have COVID-19, they could have been eligible. Assuming they met all the other criteria. Treatment has to start within five days of testing positive. Wonder if there is additional analysis for people that fit in this category. Although probably would be too few people to learn much.

There are far fewer hospitalizations and deaths in Canada of partially vaccinated folks, but it did happen. More so than for fully vaccinated people. Canada is using Astra Zeneca and Pfizer.

Late September 2021
ENHANCED EPIDEMIOLOGICAL SUMMARY
Confirmed Cases of COVID-19 Following Vaccination in Ontario: December 14, 2020 to September 18, 2021

https://www.publichealthontario.ca/-/media/documents/ncov/epi/covid-19-epi-confirmed-cases-post-vaccination.pdf?la=en