Inside Medicine. What Are You Seeing? [COVID-19 medical news]

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1601

@suzyQ7 – I’ll defer to a medical professional which is not me, but it appears that exposure to other coronaviruses (e.g., some common colds) has given some people T cells that provide protection against COVID-19. My understanding is this contributes to asymptomatic or mild symptoms for large numbers of people.

Interestingly, I remember joking to my brother (who’s a doctor) years ago that if the plague came I’d be among the first to fall b/c I “catch everything.” He quickly quipped, “or b/c you catch everything, you’d have better immunity!” He’s even smarter than I realized. :slight_smile:

Of course, we’re all hoping we’ve had this exposure – but no way to know.

1602

But presumably the older you are, the more viruses you have been exposed to. Older people are not doing well with COVID-19. And I would think younger people , who in general are doing better than the elderly, would have had less exposure. Interesting and always appreciate some hope.

I had H1N1. Wish that counted! Too bad, its a flu :frowning:

1603

:open_mouth:

FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks
From CNN’s Lauren Mascarenhas

The US Food and Drug Administration could issue emergency use authorization (EUA) of a coronavirus vaccine in a matter of weeks, once a vaccine meets efficacy requirements, Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, which approves vaccines, said Wednesday.

“We stand ready for using emergency use authorization in an appropriate setting,” Marks said during an online event called the Disease Control and Prevention Summit.
An EUA would green light a coronavirus vaccine for use on an expedited basis.

Marks said the increased attention the agency is giving to coronavirus vaccine trials should speed up the process of granting emergency use authorization to a vaccine that crosses an efficacy boundary in a clinical trial.

“We’d like to hope that when that happens, it will be a matter of weeks before we could actually potentially have something like an emergency use authorization,” said Marks, who added that he hopes the EUA will apply to a relatively broad population. “Emergency use authorization will be for the population for which we have appropriate data."

Marks emphasized that safety will not be sacrificed in the race for a vaccine.

“The first vaccines that come along may be slightly disadvantaged compared to ones that come along later,” said Marks, who suspects the “trailblazer” vaccines will reveal information that can speed up the process for subsequent vaccine candidates.

Some context: Two potential vaccines started advanced trials this week in the US.

“There are aspirational timelines, and I think that’s actually wonderful here, that people have aspirations for moving forward as quickly as possible, but we all know that real life generally does not go as well as our aspirations,” Marks said.

1604

Covid-19 vaccine may not be available until mid-2021, German minister says
From CNN’s Frederik Pleitgen

A coronavirus vaccine may not be available until the middle of next year, Germany’s minister for research Anja Karliczek warned Wednesday, as she announced further government funding to help accelerate the research and development process.

“Researchers are working at an unbelievable speed, but of course setbacks are always possible,” Karliczek said.
“We can’t expect miracles and most expect that vaccines for the vast majority of the population will only be available in the middle of next year, at the earliest,” she added.

Karliczek, speaking at a press briefing on Wednesday, said the German government would offer financial support to three labs currently developing coronavirus vaccines.

The three labs – led by pharmaceutical companies Biontech, Curevac and IDT Biologica – will share a grant of €750 million from the German health ministry, she said.

Officials hope the funding will help to accelerate both the research and development of the potential vaccines, while also increasing production capacity, Karliczek added.

“The three vaccine candidates are all very promising, but there can always be setbacks in the trials,” Karliczek said.

There are currently 25 vaccine candidates in the clinical evaluation stage of development and a further 139 at the preclinical stage, according to the World Health Organization.

1605

Monkey study indicates good news for Moderna’s experimental coronavirus vaccine
From CNN’s Maggie Fox

A study done in monkeys suggests Moderna’s experimental coronavirus vaccine might protect against severe disease and reduce the risk of passing the virus along to others.

Moderna started advanced, Phase 3 testing of its experimental vaccine in humans in the United States on Monday – the fastest advancement ever of a new vaccine in the US. But the quick vaccine development process means the vaccine was not tested extensively in animals before moving on to people.

A team at the National Institute of Allergy and Infectious Diseases, which helped develop the vaccine, tested it in rhesus macaque monkeys. Then they infected the monkeys with the virus – an experiment that would be difficult, ethically, to do in human.

Monkey tests: While the monkeys did become infected, the vaccine appeared to interfere with the spread of the virus in the animals, the NIAID team reported in The New England Journal of Medicine.

“Remarkably, after two days, no replicating virus was detectable in the lungs of seven out of eight of the macaques in both vaccinated groups, while all eight placebo-injected animals continued to have replicating virus in the lung,” the NIAID researchers said in a statement.
None of the monkeys that got the higher dose of vaccine had virus in their noses, either. That would suggest the vaccine might prevent the spread of the virus, even if people do get infected.

“This is the first time an experimental COVID-19 vaccine tested in nonhuman primates has been shown to produce such rapid viral control in the upper airway, the investigators note,” the researchers said.

“A COVID-19 vaccine that reduces viral replication in the lungs would limit disease in the individual, while reducing shedding in the upper airway would potentially lessen transmission of SARS-CoV-2 and consequently reduce the spread of disease,” they added.

The researchers note that it’s not at all clear that monkeys respond to the virus in the same way that people do. But they noted that the virus appears to replicate in the noses of the monkeys in much the same way as it does in people.

Also reassuring: One worry was that the vaccine might make the body overreact to a true infection later on, a response known as vaccine-associated enhanced respiratory disease. This didn’t happen in the monkeys, the researchers said.

1606

This is the key sentence. Neither one of the two trials (that started this week in the US, mentioned in the article above) is being tested in those under 18. So no one under 18 will be able to get these vaccines (unless FDA is going to do things very differently than in the past).

Not sure how many elderly will sign up for a trial where there are limited treatments (remdesivir, dexamethasone) which don’t work for everyone, and where there is a high risk of death should they become infected. If these trials are completed without elderly people enrolling, we won’t have data in elderly people…meaning they may not be able to get the vaccine.

Will physicians recommend a vaccine for groups where there is limited, or even no, data? Will people take vaccines (or will physicians recommend them) that don’t have any long-term safety data? I have more questions than answers!

Here are the two links to the protocols of the Phase III trials that started this week:

Moderna: https://www.clinicaltrials.gov/ct2/show/NCT04470427?cond=covid-19+vaccine&phase=2&draw=2&rank=1

Key points: 30,000 participants. 2 doses 28 days apart. Includes only “Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.” Those with immune conditions excluded, and more. No upper age limit.

Pfizer/BioNTechSE: https://www.clinicaltrials.gov/ct2/show/NCT04368728?term=pfizer&cond=covid-19&draw=2&rank=2

Phase III Key points: 32,000 participants. 1 or 2 doses. Excludes those with certain mental health issues, HIV/HCV/HBV, certain immunocompromised conditions, those taking immunosuppressants, and more. Upper age limit 85.

1607

Wouldn’t elderly be more likely to sign up compared to younger people who have similar daily life risks (e.g. same level of exposure from work and other activities)?

1608

Monkey study<<<<<<<<<

Mice lie and monkeys exaggerate ?

1609

The link to the Moderna info has this to say regarding “those with immune conditions” who do not meet eligibility requirements:

Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.
Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Screening.
Has received systemic immunoglobulins or blood products within 3 months prior to the day of Screening.

Just want to point out that this does not mention autoimmune conditions (I was specifically interested in lupus and type 1 diabetes).

1610

Right, it doesn’t mention them by name, but some with autoimmune conditions could fall out due to systemic immunosuppressant use and/or being in an immunosuppressive state.

Seems like controlled diabetes patients would be able to enroll (if they meet the rest of the criteria), but relatively fewer lupus patients as some are taking pred>20mg every day. It’s going to be the doc’s call as to what constitutes an immunosuppressive state…basically if one has a condition where they are cautioned to avoid any type of bacterial/viral infection, they won’t be able to enroll in the study.

1611

Not sure I follow, but I do think the elderly that sign up are likely to be health care providers, and maybe those in nursing homes or other congregant living situations.

Fundamentally, most elderly people should still be in stay-at-home mode. I do know that’s not happening everywhere.

1612

I think so. Especially in care facilities…they are more at risk from the killing them than from the vaccine.

1613

I can’t link the source. I read elderlies are in included in the trial.

1614

They are included in the two trials I linked above. Up to age 85 in the Pfizer trial, no upper age limit in the Moderna trial.

Getting elderly people who want to enroll in a vaccine study, who meet all of the criteria, is the issue.

1615

I meant in the third phase. Moderna had them included in their latest trial.

1616

What I linked above in post #1605 are the Phase III trial protocols of the two trials that started this week.

1617

https://www.technologyreview.com/2020/07/29/1005720/george-church-diy-coronavirus-vaccine/?utm_source=digg

“Some scientists are taking a DIY coronavirus vaccine, and nobody knows if it’s legal or if it works”
"Famed geneticist George Church and at least 20 others didn’t want to wait for the results of clinical trials: “I think we are at much bigger risk from covid.”

Sorry if this is a re post.

1618

What I was writing was that people with higher (self-assessed) personal risk of COVID-19 would be more likely to sign up for a vaccine trial. For example, among health care workers, it would not be surprising if older ones signed up for a vaccine trial at higher rates than younger ones. Or, among people of the same age, it would not be surprising if those working in health care or other professions involving contact with other people signed up for a vaccine trial at higher rates than those working from home.

Of course, self-assessed personal risk may involve other factors besides actual risk due to personal health and activity characteristics, such how serious one thinks that COVID-19 is. Other factors can also come into play when it comes to vaccine trials, such as how trusting one is of medicine in general and drug / vaccine companies in particular.

1619

Rapid antibody cure

https://www.msn.com/en-us/news/us/how-a-secretive-pentagon-agency-seeded-the-ground-for-a-rapid-coronavirus-cure/ar-BB17njj7?li=BBnb7Kz&ocid=mailsignout

1620

Agree with your examples.

One’s self-assessment of their risk of covid infection likely matters in terms of getting them to inquire about the clinical trial or consider enrolling, but it’s the clinical investigator’s assessment of the person’s risk level and whether it falls within the bounds of the protocol requirements that rules the day.

If a person meets those requirements, then the doc can move on to see if the person meets the rest of the trial inclusion/exclusion criteria and if so, enroll the person in the study.