Some vaccine development updates, some companies optimistic for potential fall 2020 availability. The article also discusses China based CanSino’s product, but I have seen nothing to suggest that this product will be tested or distributed in the US.
I doubt FDA will approve chinese vaccine. They are not trust worthy. There was a report recently how chinese researchers are flooding peer review publications. They found 121 “original” research using exact same images. They are burdening research infrastructure. Research on paper is relatively harmless compared to vaccine research.
There are FDA approved Chinese manufacturers, and there are some drugs available in the US that have been manufactured in China.
That was fascinating - thanks for posting!
That article says:
@ucbalumnus , that paragraph stood out to me as well.
FDA gives “Fast Track” status to two Covid-19 vaccine candidates
From CNN Health’s Wes Bruer
Pfizer and BioNTech announced today that they have received “Fast Track” designations from the US Food and Drug Administration for two of their four Covid-19 vaccine candidates, according to a press release.
“This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies,” the release stated.
What this means: Fast Track designation allows for a more efficient development process between companies and regulatory agencies and makes drug developers eligible for accelerated approval with a rolling review process of submitted data.
Companies must request the designation and it is reserved for “any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need,” according to the FDA’s website.
Next steps: Pfizer and BioNTech’s collaboration on Covid-19 vaccine development, dubbed “Project Lightspeed,” expects to begin phase 2b/3 of its trial later this month. The companies aim to enroll 30,000 participants, according to the press release.
Pending the success of ongoing studies, “the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.”
“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president of global regulatory affairs for Pfizer, said in a statement. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”
“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Özlem Türeci, chief medical officer at BioNTech, said in the statement.
@doschicos I saw this earlier today, sounds very promising!
Agree as long as the vetting and testing is done sufficiently. For many reasons, we can’t risk a screw up in getting these vaccines done correctly. When politics and misguided incentives are mingled in, my antennae start twitching a little.
Natural immunity to Covid-19 could decline within months, UK study suggests
From CNN’s Jacqueline Howard
If you were infected with the novel coronavirus, a new study suggests that your immunity to the virus could decline within months.
The study, released on the pre-print medical server medrxiv.org on Saturday, suggests that antibody responses start to decline after 20 to 30 days following the first time showing symptoms of Covid-19. The study also found the severity of symptoms can determine the magnitude of the antibody response.
The study, which has not been published in a peer-reviewed medical journal, included samples collected from 65 patients with confirmed Covid-19 up to 94 days after they started showing symptoms and from 31 health care workers who had antibody tests every one to two weeks between March and June.
Limitations of the study: More research is needed to determine whether similar results would emerge among a larger group of patients and to continue measuring antibody responses over a longer period of time.
“Whilst yet to be peer reviewed, the importance of this study is clear and the research has been rigorously undertaken. This work confirms that protective antibody responses in those infected with SARS-COV2, the coronavirus that causes COVID-19, appear to wane rapidly. Whilst longer lasting in those with more severe disease, this is still only a matter of months,” Dr. Stephen Griffins, associate professor in the University of Leeds School of Medicine in the United Kingdom, who was not involved in the new study, said in a written statement distributed by the UK-based Science Media Centre on Monday.
“Similar short-lived responses are seen against other human coronaviruses that predominantly cause only mild illness, meaning that we can be re-infected as time goes by and outbreaks can adopt seasonality. With the more serious, sometimes fatal, outcomes of SARS-COV2, this is troubling indeed,” Griffins said. “Vaccines in development will either need to generate stronger and longer lasting protection compared to natural infection, or they may need to be given regularly.”
According to the World Health Organization, as of last week, there were at least 21 Covid-19 candidate vaccines in clinical evaluation globally.
1 in 3 young adults is vulnerable to severe Covid-19, and smoking plays a big part, research finds
From CNN’s Naomi Thomas
One in three young adults is at risk of severe Covid-19, and smoking plays a big part in that risk, according to new research published Monday in the Journal of Adolescent Health.
Researchers at the University of California, San Francisco, looked at more than 8,000 participants ages 18 to 25 who had participated in the National Health Interview Survey to see what their medical vulnerability to severe Covid-19 was in relation to risk indicators that had been set out by the US Centers for Disease Control and Prevention, including health conditions and smoking habits.
The researchers found 32% of the total study population were medically vulnerable for severe Covid-19. However, when the group of participants who smoked cigarettes or e-cigarettes were taken out of the analysis, the medically vulnerable percentage decreased by half, to 16%.
“The difference between estimates is driven largely by the sizeable portion of young adults who reported that they engaged in past 30-day smoking (1 in 10) and past 30-day e-cigarette use (1 in 14),” the report said. “By contrast, relatively fewer young adults reported medical conditions identified by the CDC as conferring severe illness risk.”
The research showed that in the whole study population, young adult men were at a higher risk for severe Covid-19. Although more women reported having asthma and immune conditions, higher rates of smoking in men overrode this. However, looking at just the non-smokers, women had a higher risk.
“Recent evidence indicates that smoking is associated with a higher likelihood of COVID-19 progression, including increased illness severity, ICU admission or death,” said Sally Adams, lead author of the study, in a press release. “Smoking may have significant effects in young adults, who typically have low rates for most chronic diseases.”
Other findings: Another interesting finding from the research is that in the 18 to 25 age group, White young adults had the highest vulnerability.
“Our finding of lower medical vulnerability of racial/ethnic minorities compared with the white subgroup, despite controlling for income and insurance status, was unexpected,” the study said. “It is also inconsistent with research showing higher rates of Covid-19 morbidity and mortality and other chronic illnesses among racial/ethnic minorities, specific to one age group.”
The researchers said it is also inconsistent with the 15 to 24 age group, where Hispanic and Black Americans were shown to have the highest rates of Covid-19 deaths.
“This suggest that factors other than the CDC’s medical vulnerability criteria play a role in the risk of severe Covid-19 illness in the young adult population,” the researchers said.
The study did have some limitations, including the lack of information about Covid-19 in the 18 to 25 population, and a chance that it could underestimate the vulnerability rates for certain ethnic or racial subgroups of young adults due to the data source.
Very strange, because we know that the large majority of young adults, if infected, do not have severe disease.
1 +2 = 3
2 out of 3 is a “large majority” (67%)
1 in 3 is a “minority” (33%)
Not strange at all. Just math.
The text in #1290 does not define “vulnerable” in terms of how likely each group is to get severe COVID-19. It could mean that that 1/3 of young adults merely has a much higher chance of severe COVID-19 compared to the other 2/3. but “much higher” than a very low chance is merely low.
Of course, there still seems to be very little information on the frequency of severe COVID-19 other than death rates (which are themselves fuzzy due to incomplete knowledge about asymptomatic infections), so any levels of risk are given in subjective descriptions that could mean different things to different people. For example, if you get COVID-19, what is the chance you will have a severe problem, like extended period of infection, need for hospitalization, long term lung, heart, or other damage, etc., and how does that chance change based on various personal risk factors?
In the USA , approx 20% of young people 12-19 are obese. and many more are overweight, a bit under 200K kids under 19 have diabetes (type 1 or 2). about 15K kids have CF, that is just the tip of the iceberg of risk. So many reasons why kids are not some homogeneous group.
I disagree. If 1/3 of the population do the same perceptually, it will look overwhelming. Since it doesn’t, I’d say it is a lot kess.
Very nervous about kid with type 1 diabetes. Nervous about the virus but also about any possible hospitalization. Hospitals do not know how to manage type 1. I have always been at the bedside managing if kid is sick. Now I am 3,000 miles away and even if I were to fly there, they wouldn’t let me in, Hoping that virtual management would be allowed, using the technology that is now available.
Dexamethasone and other steroids are a nightmare for diabetes management. They can be used, but it is very tricky because blood sugars triple, so insulin has to be increased. Then when you come off the steroids, there is risk of serious lows unless insulin is decreased skillfully.
We are not sure of the level of risk for type 1 in an otherwise healthy young person. Many older type 2’s have cardiovascular and other complications. Type 1 has nothing to do with weight. It is an autoimmune disorder so there are also concerns about immune response.
The entire supply chain needs to get ready!
Considering that the supply chain is hopelessly broken for testing supplies, I am not optimistic.
I am a bit more optimistic here. Glass vials are a little easier to come by than those elusive cotton swabs made by the only US manufacturer. Also, testing supplies involve quite a number of very sophisticated reagents, and those could not be manufactured in mass quantities overnight (many involve multiple steps that simply cannot be sped up).