Covid-19 Vaccine Development

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DH and I are hoping that we're able to get a vaccine that doesn't require a second dose. Based on what we've read, we're leaning towards the J & J if given the choice.

We received another email from Beaumont Health this morning providing a few more details about scheduling appointments for vaccination. At the outset, there will be only one local facility where folks can get the shot, and Southfield isn't exactly convenient for us. Neither of us will schedule a vaccine appointment until we've spoken with our respective physicians. Hopefully, both will have had experience with other geriatric patients getting the vaccine by the time we see them later this month (DH) and early February (me).
Unfortunately the single dose J&J vaccine is not nearly as effective as the two-dose Pfizer and Moderna vaccines. MOO I would get the J&J vaccine only if the others are not available.
 
Re: Bamlanivimab & Vaccination / combined post with submission by @anneg

  • Via @anneg:
  • Persons who previously received passive antibody therapyCurrently, there are no data on the safety and efficacy of mRNA COVID-19 vaccines in persons who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Based on the estimated half-life of such therapies as well as evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days, as a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses. This recommendation applies to persons who receive passive antibody therapy before receiving any vaccine doses as well as those who receive passive antibody therapy after the first dose but before the second dose, in which case the second dose should be deferred for at least 90 days following receipt of the antibody therapy.

  • Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines | CDC
—-

Bamlanivimab (Reference):

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
Nov. 02, 2020

“Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.“



Fact Sheet for Patients, Parents and Caregivers
Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19)

https://www.fda.gov/media/143604/download



Jan. 21, 2020
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents | Eli Lilly and Company



New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent



CIDRAP / Jan. 21, 2020
Combo monoclonal antibody drugs may lower coronavirus loads



This COVID-19 treatment may cut hospitalizations by 70%

Eli Lilly released results of a late-stage study on Tuesday, showing that its cocktail — named bamlanivimab — combined with the monoclonal antibody called etesevimab can cut hospitalizations for high-risk COVID-19 patients.
  • Per USA Today, the drug “mimics one of the natural antibodies the immune system uses to fight off the virus.”
The study said 10% of patients who receive a placebo went to the hospital. Meanwhile 2% of those who received the full cocktail had to go the hospital, according to USA Today. That’s a 70% drop.
  • The patients involved in the study were diagnosed with COVID-19 four days before they were treated with the drug, according to USA Today.
  • None of the 518 patients who received the cocktail died from COVID-19. Eight people who took the placebo did die.”


Monoclonal Antibody Treatment: Frequently Asked Questions: COVID-19 - Minnesota Dept. of Health

“Antibody treatment can be used by people with mild to moderate COVID-19 who:
  • Test positive for SARS-CoV-2.
  • Are within 10 days of the start of their symptoms.
  • Are age 12 or older and weigh at least 88 pounds.
  • Are at high risk of getting very sick from COVID-19 or of needing to be admitted to a hospital because of COVID-19.“
[...]

“Clinical trials for bamlanivimab and for casirivimab/imdevimab have shown a decrease in hospitalizations and emergency room visits and a decrease in the amount of virus in an infected person's blood. Studies are still ongoing.”

[...]

Who is considered at high risk?
High risk for progressing to severe COVID-19 and/or hospitalization is defined as patients who meet at least one of the following criteria:
  • Have a body mass index (BMI) greater than 35.
  • Have chronic kidney disease.
  • Have diabetes.
  • Have immunosuppressive disease.
  • Are currently receiving immunosuppressive treatment.
  • Are 65 years of age or older.
  • Are 55 years of age or older AND have one or more of the following:
    • Cardiovascular disease.
    • Hypertension.
    • Chronic obstructive pulmonary disease/other chronic respiratory disease.
  • Are 12-17 years of age AND have one or more of the following:
    • Body mass index greater than 85th percentile for their age and gender, based on CDC: Clinical Growth Charts.
    • Sickle cell disease.
    • Congenital or acquired heart disease.
    • Neurodevelopmental disorders, for example, cerebral palsy.
    • A medical-related technological dependence; for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).
    • Asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control.
Screening Tool for Monoclonal Antibody Treatment (PDF)
 
Re: Bamlanivimab & Vaccination / combined post with submission by @anneg

  • Via @anneg:
  • Persons who previously received passive antibody therapyCurrently, there are no data on the safety and efficacy of mRNA COVID-19 vaccines in persons who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Based on the estimated half-life of such therapies as well as evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days, as a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses. This recommendation applies to persons who receive passive antibody therapy before receiving any vaccine doses as well as those who receive passive antibody therapy after the first dose but before the second dose, in which case the second dose should be deferred for at least 90 days following receipt of the antibody therapy.

  • Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines | CDC
—-

Bamlanivimab (Reference):

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
Nov. 02, 2020

“Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.“



Fact Sheet for Patients, Parents and Caregivers
Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19)

https://www.fda.gov/media/143604/download



Jan. 21, 2020
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents | Eli Lilly and Company



New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent



CIDRAP / Jan. 21, 2020
Combo monoclonal antibody drugs may lower coronavirus loads



This COVID-19 treatment may cut hospitalizations by 70%

Eli Lilly released results of a late-stage study on Tuesday, showing that its cocktail — named bamlanivimab — combined with the monoclonal antibody called etesevimab can cut hospitalizations for high-risk COVID-19 patients.
  • Per USA Today, the drug “mimics one of the natural antibodies the immune system uses to fight off the virus.”
The study said 10% of patients who receive a placebo went to the hospital. Meanwhile 2% of those who received the full cocktail had to go the hospital, according to USA Today. That’s a 70% drop.
  • The patients involved in the study were diagnosed with COVID-19 four days before they were treated with the drug, according to USA Today.
  • None of the 518 patients who received the cocktail died from COVID-19. Eight people who took the placebo did die.”


Monoclonal Antibody Treatment: Frequently Asked Questions: COVID-19 - Minnesota Dept. of Health

“Antibody treatment can be used by people with mild to moderate COVID-19 who:
  • Test positive for SARS-CoV-2.
  • Are within 10 days of the start of their symptoms.
  • Are age 12 or older and weigh at least 88 pounds.
  • Are at high risk of getting very sick from COVID-19 or of needing to be admitted to a hospital because of COVID-19.“
[...]

“Clinical trials for bamlanivimab and for casirivimab/imdevimab have shown a decrease in hospitalizations and emergency room visits and a decrease in the amount of virus in an infected person's blood. Studies are still ongoing.”

[...]

Who is considered at high risk?
High risk for progressing to severe COVID-19 and/or hospitalization is defined as patients who meet at least one of the following criteria:
  • Have a body mass index (BMI) greater than 35.
  • Have chronic kidney disease.
  • Have diabetes.
  • Have immunosuppressive disease.
  • Are currently receiving immunosuppressive treatment.
  • Are 65 years of age or older.
  • Are 55 years of age or older AND have one or more of the following:
    • Cardiovascular disease.
    • Hypertension.
    • Chronic obstructive pulmonary disease/other chronic respiratory disease.
  • Are 12-17 years of age AND have one or more of the following:
    • Body mass index greater than 85th percentile for their age and gender, based on CDC: Clinical Growth Charts.
    • Sickle cell disease.
    • Congenital or acquired heart disease.
    • Neurodevelopmental disorders, for example, cerebral palsy.
    • A medical-related technological dependence; for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).
    • Asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control.
Screening Tool for Monoclonal Antibody Treatment (PDF)


Question as you seem up on it. Has there been a directive that anyone who is positive for COVID and has illness should WAIT at least 90 days or so to get a vaccine? (Seems to me it might just overwhelm the immune system!!)
 
Last edited:
DH and I are hoping that we're able to get a vaccine that doesn't require a second dose. Based on what we've read, we're leaning towards the J & J if given the choice.

We received another email from Beaumont Health this morning providing a few more details about scheduling appointments for vaccination. At the outset, there will be only one local facility where folks can get the shot, and Southfield isn't exactly convenient for us. Neither of us will schedule a vaccine appointment until we've spoken with our respective physicians. Hopefully, both will have had experience with other geriatric patients getting the vaccine by the time we see them later this month (DH) and early February (me).
Unfortunately the single dose J&J vaccine is not nearly as effective as the two-dose Pfizer and Moderna vaccines. MOO I would get the J&J vaccine only if the others are not available.
Question as you seem up on it. Has there been a directive that anyone who is positive for COVID and has illness should WAIT at least 90 days or so to get a vaccine? (Seems to me it might just overwhelm the immune system!!)
The healthcare system where I am employed is not giving vaccinations to anyone who has had COVID within the past 90 days. It’s one of the qualifications that is gone over when appointments are scheduled, and before the vaccine is administered.
 
Our hospital now has a daily “waiting list” where employees can sign up to receive their vaccination if there is leftover vaccine. This insures that not even a single dose will be wasted.

Employees are encouraged to sign up every day that they are working in case the opportunity arises for vaccination.
 
Question as you seem up on it. Has there been a directive that anyone who is positive for COVID and has illness should WAIT at least 90 days or so to get a vaccine? (Seems to me it might just overwhelm the immune system!!)

From the CDC (BBM)
Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines | CDC

Vaccination of persons with a SARS-CoV-2 infection or exposure
Persons with a current or prior history of SARS-CoV-2 infection

Data from clinical trials indicate that mRNA COVID-19 vaccines can safely be given to persons with evidence of a prior SARS-CoV-2 infection. Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection for the purposes of vaccine decision-making is not recommended.

Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation. This recommendation applies to persons who develop SARS-CoV-2 infection before receiving any vaccine doses as well as those who develop SARS-CoV-2 infection after the first dose but before receipt of the second dose.

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, may increase with time following initial infection.

For vaccinated persons who subsequently develop COVID-19, prior receipt of an mRNA COVID-19 vaccine should not affect treatment decisions (including use of monoclonal antibodies, convalescent plasma, antiviral treatment, or corticosteroid administration) or timing of such treatments.
 
they are doing a 2 dose study on the J&J vaccine as well

Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate | Johnson & Johnson

curious if 2 doses give a higher percentage of immunity


"One hope is that the efficacy of the Johnson & Johnson vaccine could rise if it is given as a two-dose regimen. Johnson & Johnson is running another large study, enrolling 30,000 patients, testing two doses of the vaccine given 57 days apart. However, Stoffels said, waiting that long between doses will slow results. He expects results of the two-dose study to read out in the summer or fall."

J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch
 
Covid Mutations Undercut Optimism Even as More Vaccines Get Near
Jan. 29, 2021


“Vaccines made by Moderna Inc. and the Pfizer Inc.-BioNTech SE partnership are already in use. Meanwhile, new studies show that two more -- from Johnson & Johnsonand Novavax Inc. -- pack potent punches against early forms of the virus, potentially paving the way for quick authorizations in the U.S. for J&J’s vaccine and in the U.K. for Novavax’s shot. That’s the good news, offering the promise of ending a pandemic that’s killed more than 2 million people worldwide.

Now comes the bad news: Mutations that likely confer partial resistance to vaccines and antibody treatments are now prevalent in both South Africa and Brazil, and threatening to spread worldwide. The J&J shot was found in a late-stage trial to be 72% effective in the U.S., but that fell to 57% in studies done in South Africa. Novavax’s shot, 89% effective in the U.K., was only 49% effective in South Africa.”
 
Covid Mutations Undercut Optimism Even as More Vaccines Get Near
Jan. 29, 2021


“Vaccines made by Moderna Inc. and the Pfizer Inc.-BioNTech SE partnership are already in use. Meanwhile, new studies show that two more -- from Johnson & Johnsonand Novavax Inc. -- pack potent punches against early forms of the virus, potentially paving the way for quick authorizations in the U.S. for J&J’s vaccine and in the U.K. for Novavax’s shot. That’s the good news, offering the promise of ending a pandemic that’s killed more than 2 million people worldwide.

Now comes the bad news: Mutations that likely confer partial resistance to vaccines and antibody treatments are now prevalent in both South Africa and Brazil, and threatening to spread worldwide. The J&J shot was found in a late-stage trial to be 72% effective in the U.S., but that fell to 57% in studies done in South Africa. Novavax’s shot, 89% effective in the U.K., was only 49% effective in South Africa.”

reading about these studies I have become curious if the amount of community spread at the time of the study impacts the % results- do they account for that? I heard one of the J&J reps interviewed on the radio say that they were testing in Brazil and in S. Africa when there was a lot of exposure to virus. wouldn't a high community virus rate cause more exposure while a low community rate might make a vaccine seem more effective than it really is?
 
Covid-19: C.D.C. Order Requires Masks for Travel in U.S.
Countries are tightening borders to evade virus variants...

“At least one confirmed case of the South Africa-based coronavirus variant has been detected in the Baltimore metro region.

Gov. Larry Hogan of Maryland on Saturday said there had been at least one confirmed case in the state of a more contagious variant of the coronavirus found in South Africa that has proved to be more resistant to vaccines.“

[...]

“The variant was first detected in the United States this week in South Carolina, which is already experiencing one of the worst coronavirus outbreaks in the nation. Not long after, a second case was discovered with no known connection to the first, state officials announced on Thursday.

Neither patient had a history of travel, officials said, suggesting what many public health experts feared had come to pass: The new variant of the virus had taken root in the United States.

The Biden administration on Saturday put in place a ban on incoming travel from South Africa of noncitizens.

Known as B.1.351, the variant is one of several that have emerged during the pandemic. Others include a variant from Brazil, which has been detected in Minnesota, and one from Britain, which is spreading more widely in the United States.”

[...]

“Epidemiologists tracking the United States epidemic were already concerned that the variant first identified in Britain could become the dominant strain circulating in the United States by March. The United States is conducting little of the genomic sequencing necessary to track the spread of new variants that have caused concern.

Both Moderna and Pfizer-BioNTech — the companies manufacturing the two vaccines on the U.S. market — have said their shots are slightly less effective against the variant from South Africa, and the companies are considering creating either a booster shot or new version to head off the variant. The vaccine developed by Novavax, which has yet to be administered in the United States, appeared to be especially ineffective in trials at protecting against the South Africa variant.

Public health officials including Dr. Anthony S. Fauci, the nation’s top infectious disease expert, have warned that circulation of new variants with increased transmissibility would invariably lead to more infections, and by extension, increased hospitalizations and deaths. Dr. Fauci said Friday that new clinical trial results from Johnson & Johnson, showing that its vaccine is less effective against the variant from South Africa, were a “wake-up call.”

—-

Countries tighten borders as alarm over coronavirus variants grows.

“Countries are tightening their borders as a ban takes effect Saturday on noncitizens traveling to the United States from South Africa, amid warnings over the threat posed by a virus variantspreading rapidly there and signs that it can weaken the effectiveness of vaccines.

In recent days, Johnson & Johnson and Novavax have each announced that their vaccines provided strong protection against Covid-19, but the results came with a significant cautionary note: Their efficacy rate dropped in South Africa, where the highly contagious variant is driving most cases. Studies suggest that the variant also blunts the effectiveness of Covid vaccines made by Pfizer-BioNTech, Moderna and Novavax.

The variant, B.1.351, has spread to at least 31 countries, including two cases documented in the United States this week.“
 



Osterholm Update: COVID-19
Episode 42: Calling an Audible
February 4, 2021
In this episode, Dr. Osterholm and host Chris Dall discuss the latest challenges related to variants of concern, the case for delaying second doses of current vaccines to broaden access to first doses, and double masking.

 
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Coronavirus variants are cause for concern, but future mutations may be the real problem.
The tiny spike proteins that cover the outside of the virus are crucial to vaccine efficacy. They're also changing.

“An early analysis from Moderna found that while its vaccineappears to be less effective against the South African variant, antibodies remained above protective levels. The Pfizer-BioNTech vaccine is only slightly less effective against the South African strain, according to a study that hasn't yet been peer-reviewed.“



“Another mutation, called E484K, could help the virus dodge some attack by a person's immune system and may affect how well coronavirus vaccines work.“

South Africa coronavirus variant: What is the risk?
3 days ago
 

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