9/17/2023: FDA approved the updated mRNA COVID-19 vaccine boosters from Moderna and Pfizer on Sept 11th, 2023. CDC recommends the new COVID boosters for all Americans over 6 months of age and older on Sept 12th, 2023. These vaccine boosters will closely target the current circulating variants to protect against serious hospitalization and deaths. It is monovalent corresponding to Omicron variant XBB.1.5.
The vaccines from Modena and Pfizer are approved for 12 years of age and older and are authorized for emergency use for 6 months-11 years of age. Individuals of 5 years of age and older are eligible to receive a single dose regardless previous vaccination. The supporting data for the two vaccine boosters include manufacturing data to support the 2023-2024 boosters' formula, and non-clinical immune response data for the updated formulations target toward XBB.1.5 component. FDA believes the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine.
As part of the decision, the bivalent COVID-19 vaccines made by Moderna and Pfizer-BioNTech are no longer authorized for use in the US.
6/24/2023: FDA approved Pfizer’s drug Litfulo for treating hair loss that is caused by an autoimmune disease where the immune system attacks hair follicles and causes hair to fall out. The drug is approved for people of 12 years or older who suffer from sever alopecia areata (AA). This is the first drug approved to treat the condition in adolescents. This drug is an oral dosage form. It will be available in the coming weeks.
Eli Lilly's drug Olumiant approved in June 2022 is used to treat the condition in adults.
4/1/2023: Nexletol (Bempedoic acid), a non-statin drug, was approved by FDA in 2020 to help adults who need to lower the bad cholesterol, low-density lipoprotein cholesterol (LDL-C). A recent study published in the New England Journal of Medicine (March 4, 2023) looked at 13,970 patients from 32 countries, with a group treated with bempedoic acid and the other group treated with placebo for a median period of 40.6 months. In the group treated with bempedoic acid, there was 21% more reduction in LDL-C and 13% lower chance of experiencing cardiovascular events, such as heart attack or stroke. This study shows bempedoic acid indeed provides benefits to decrease cardiovascular events.
Therefore, Nexletol can be an effective alternative drug to Statins (Simvastatin or Pravastatin) to lower LDL-C. Statins are gold standard to lower cholesterol, especially LDL-C, but they could cause musculoskeletal aches and some other uncomfortable side effects (increased blood sugar, brain fog or liver damage).
1/28/2023: If you have had COVID vaccines or were infected by COVID-19, it is possible that you may have experienced the symptom of an increased heartbeat (by 30 beats/minute or more) during the standing position (for more than 10 minutes or longer). There could also be other symptoms including palpitation, weakness, light headedness, nausea, headache or pre-syncope. These symptoms are collectively called the Postural Orthostatic Tachycardia Syndrome (POTS) that could occur within three months after COVID infection or COVID vaccination.
The rate of new POTS diagnoses is five-fold lower after COVID-19 vaccination than that after COVID infection. This is based on the POTS analyses to 284,592 COVID vaccinees and 12,460 COVID positive people published in a recent News and Views article in Nature Cardiovascular Research. This finding supports COVID vaccinations for preventing infections by COVID-19.
11/20/2022: According to CDC, two new COVID variants BQ.1 and BQ.1.1 in the US have now taken over the earlier dominant variants BA.4 and BA.5. BQ.1.1 counts ~44% among new cases. BA.4 has nearly disappeared while BA.5 is counting for ~30% of the cases and is quickly declining. Experts are predicting there could be another wave of COVID cases in the winter months.
So, the vulnerable Americans who have underline health conditions should get a booster of the new bivalent mRNA vaccines by Pfizer and Moderna. Novavax (adjuvanted) vaccines can be used as a first booster too. Having an interval of 5-6 months between boosters should be more effective allowing the immune systems more time to refine its response.
Though the boosters are effective to prevent serious illness, they are not every effective in preventing infections. Some experts including the FDA’s top vaccine regulator believe boosters must be improved in the future. New strategies should be considered, such as designing a vaccine that targets the part of virus that does not mutate with time. In addition, a nasal vaccine might be better in preventing infections than the injected ones.
10/22/2022: Both FDA and CDC this week have approved the emergency use of Novavax COVID-19 vaccine, adjuvanted as a booster shot for adults who have got the primary shots of the vaccines by Pfizer, Modena and J&J. Novavax COVID-19 vaccine is manufactured as a traditional protein vaccine with an adjuvant that is different from the mRNA or DNA vaccines. Novavax COVID-19 vaccine is claimed to generate antibody response to the Omicron variant BA.5, though the real world effect is not known yet. Novavax COVID-19 vaccine has also been approved for emergency use for a primary two doses series vaccine back to July for 18 years and older and later approved in August for people of 12-17 years old.
10/10/2022: Though the US is not in COVID-19 pandemic any more, the most recent 7-day average of COVID-19 cases is still 40,436 a day in the US. The current new Omicron subvariant in the US is BA.4.6; ~20% new cases are caused by BA. 4.6 and ~80% of new cases are still caused by BA.5. The symptoms of having COVID-19 are mild for most people. But, around 13.3% people infected with COVID-19 then develop long COVID symptoms after 4 weeks or longer of being infected by COVID. Long COVID refers to lingering infection though not detected by tests, debilitating fatigue and brain fog, cardio vascular symptoms (palpitation, dizziness, short of breath) and gastrointestinal distress (diarrhea, constipation abdominal pain).
The reasons for Long COVID is not very clear. It could be due to dysregulated immune response that can produce harmful inflammation in places like heart and brain. It can also be due to tiny blood clots that can cause microscopic blockage that deprive organs of needed oxygen and lead to symptoms.
So, as the winter season comes, it should be beneficial to get vaccinated or boosted with the new vaccines from Pfizer or Modena that are invented to target Omicron variants.
8/22/2022: Aspirin, one of the oldest and most used drugs has been around for 125 years. The drug, made from salicylic acid that exists in the leaves of the willow tree (genus of Salix) by reacting it with acetyl chloride, can reduce fever and headaches (including acute migraine), joint pain or arthritis. It is a nonsteroidal anti-inflammatory drug (NSAID). Every year, the drug consumption around the world is about 44,000 tons. It is on the WHO’s List of Essential Drugs.
Regarding its long term use to reduce the risks for stroke, myocardial infarction and other vascular events, it does have the efficacy for primary prevention. Instead, long term use can increase the risk of upper gastrointestinal bleeding. However, it has secondary effects for preventing vascular events.
7/30/2022: While we all know our body needs a daily vitamin D of 600-800 IU in order to have a stronger bone, it does not mean the more vitamin D we take, the better it is to our health. Newest findings by Brigham and Women’s Hospital’s study of nearly 26,000 Americans in their 50s or older show that Vitamin D3 of a daily 2000 IU (versus the participants who took dummy pills) for 5 years did not reduce the risk of broken hips nor prevent heart disease, cancer or memory loss either. Even for the 20% of the participants who took daily Vitamin D3 and calcium supplements, it did not provide benefits either. This study was reported in the recent New England Journal of Medicine. The study did not include people who may require Vitamin D supplements due to osteoporosis or other special disorders.
Dr. JoAnn Manson who started the study has a great advice for us that spending time outdoors, staying physically active, and having heart-healthy diets will lead to greater gains in health for most people.
7/18/2022: WHO announced monkeypox as a global health emergency. Currently, worldwide there are 16,016 cases of monkeypox with 4132 cases occurred in the past week. Europe has the highest number of cases of 11,865. The US is having more than 2800 cases reported with two cases being children.
Symptoms includes fever, body aches, chills, fatigue and the bumps on parts of the body. Monkeypox so far are largely transmitted among men who have sex with men of new or multiple partners. Other people could get monkeypox too through close or intimate contact.
The US is currently distributing the vaccine Jynneos against Monkeypox. The vaccine can be offered to people who realize they could have been infected.
7/05/2022: According to a very recent article on Fortune, there are six categories of people tend to have Long COVID symptoms that include ear numbness, a sensation of brain on fire, constipation, peeling skin and etc. These six categories include: 1) people who’ve had repeat COVID infections, regardless of severity. 2) people who had a high viral load during their COVID infection. 3) people who harbor dormant Epstein-Barr Virus. 4) people who have an autoimmune condition. 5) people who had neurological symptoms during their COVID infection, such as loss of smell or taste, and bad headaches. 6) people who haven’t been vaccinated.
6/18/2022: Good news for parents who have been waiting for the approval of a COVID-19 Vaccine for their young children of 6 months to 5 year old! Yesterday, FDA approved Moderna’s COVID-19 vaccine (EUA) for children between 6 months and 5 years old. It will take two doses (25% of the adult dose), 4 weeks apart. In the meantime, FDA has also approved Pfizer-BioNTech’s COVID-19 vaccine (EUA) for children of 6 months to 4 years old. It will take 3 doses (10% of the adult dose). The first two doses are three weeks apart. The third dose should be given at least 8 weeks after the second dose.
Today, the advisory group of CDC has unanimously recommended the use of both vaccines for the young children of this age group. It is expected that the CDC director, Dr. Rochelle Walensky will endorsed it later today. The children could have the vaccines as early as next Monday.
According to CDC, COVID-19 is a leading cause for death of children of 1-4 years old, though there are much fewer children who died from COVID-19 than adults. So, it is significant that the parents will be able to have their young children vaccinated if they choose to.
6/12/2022: The long waited NOVAVAX COVID-19 vaccine was endorsed by the FDA advisory committee last week with a vote of 20-0 for an emergency use approval. If approved by FDA and CDC in the near future, American people will have one more option of COVID-19 vaccine. What is very important is that it is a protein vaccine (with a saponin adjuvant) that delivers SARS-COV-2 spike protein, a traditional vaccine, like vaccines for influenza. Hopefully for the people who have not got mRNA or a DNA vaccine, they will feel more comfortable to take this one. This vaccine can also be used as a booster for the people who have got a mRNA or a DNA vaccine. The mixing-match booster approach could generate more benefits. In addition, NOVAVAX COVID-19 vaccine can be potentially used as an attractive pediatric vaccine (once proved to be safe and effective) for children whose parents have not felt comfortable for them to get the Pfizer or Moderna’s vaccines.
5/30/2022: The issue of Nature of May 16th, 2022 reported that Influenza vaccine could cut risks against COVID-19 for a few months. The finding is based on the data collected in more than 30,000 health workers in Qatar in late 2020 before COVID-19 vaccines became available. The protection against severe COVID-19 symptoms was around 90%. The mechanism of the protection is not fully clear. It could be due to Influenza vaccine revving up broad acting antiviral defenses of the body. Such protection was beneficial in saving people’s life before the COVID-19 vaccines were available.
5/5/2022: FDA today puts a strict limit to the use of J&J’s COVID-19 vaccine only to people who have no access to or are severely allergic to Pfizer or Moderna’s COVID-19 vaccines or specifically request J&J’s vaccine. This decision is because the J&J's vaccine can cause a rare but serious blood clots that can cause stroke. The problem happens two weeks after the vaccine. Up to mid-March this year, 60 cases of the side effect were found in the US among the people who received the vaccine, about 3.23 clots in 1 million people; fatality rate is 1 person in one million vaccinated people. Symptoms of the side effects include headaches, abdominal pain and nausea.
4/20/2022: Two new Omicron sub-variants BA.2.12 and BA.2.12.1 are now spreading in the US and account for about 20% of the new cases currently. BA.2.12.1 is more transmissible than BA.2, but not known if it would cause more severe symptoms than BA.2 yet.
4/9/2022: Dr. Fauchi, Director of NIAID said the COVID-19 cases in US likely will rise in the coming weeks and in fall because Omicron variant BA.2 is becoming dominant and is more transmissible than the original Omicron variant. Currently the cases are rising in UK, indicating US will likely follow the suit. COVID cases in recent days have gone up in Washington DC, New York State, California and some other states.
Dr. Fauchi recommends people who are eligible for a 4th shot now should take it. For the future, he thinks an annual booster shot in fall like for Flu Vaccine will be likely be the scenario.
3/29/2022: US FDA has just approved a 4th booster shot for people of 50 years or older. CDC quickly backed this decision. CDC also recommends all adults who received two doses of J&J’s COVID vaccine can get a third shot of Pfizer or Moderna’s vaccine. However, the adults who got one shot of J&J’s vaccine and one shot of Pfizer or Moderna’s vaccine is not eligible to get a third shot yet, unless they are 50 years or older or have compromised immune systems. All of the new boosters have to be at least 4 months after the last shot.
3/18/2022: Based on an article on NY Times on March 15th, J&J’s COVID-19 vaccine (a DNA vaccine) works slightly better than the mRNA vaccines (by Pfizer/BioNTech and Moderna) for long term in preventing infection, hospitalization and death. This is based on the latest data collected by CDC as of Jan 22 this year. About 17 million American got J&J’s vaccine, which is a one-dose vaccine and only requires refrigerated storage. The result is a good surprise for J&J’s vaccine. As far as side effects are concerned, J&J’s vaccine could cause 4 cases of a rare blood clotting event per million of vaccinated people; for women of 30-39 years old, the rate of the blood clotting event is 11 cases per million vaccinated. mRNA vaccines by Pfizer/BioNTech and Moderna could cause 11 cases of myocarditis per 100,000 vaccinated males of 16-29 years old.
2/19/2022: According to the article ‘Dry Eye Disease, An Update in 2022’ in the Journal of the American Medical Association (published on Feb 1, 2022), dry eye disease impacts about 5% American adults. Symptoms include foreign particle sensation, irritation, blurred vision, and tearing.
Dry eye disease can be caused by stress, anxiety, depression and medications including diuretics, antihistamines, and antidepressants. Some medical conditions including Sjogren syndrome, rheumatoid arthritis or chronic systemic graft-vs-host disease can cause dry eye disease too.
For treatments, lubrication with artificial tears and ointments are most common. Many of these products contain a preservative; if used for more than 4-6 times a day, they could cause damages to ocular surface. Punctal occlusion can be used to increase the contact time of tears and ophthalmic medications with the cornea by reducing their entry into the lacrimal drainage system.
Therapeutics drugs like oral doxycycline, topical or oral azithromycin may be particularly effective to the dry eye disease caused by meibomian gland dysfunction. If the dry eye disease is caused by abnormal eyelid anatomy, surgery may be recommended.
In addition, exercises increase tear secretion and a diet with low glycemic index foods can help to reduce dry eye symptoms.
1/30/2022: As the number of COVID-19 cases in the US is declining from the record peak in these recent days, another variant, Omicron BA.2 is being talked about more and more. Like the original Omicron variant BA.1, BA.2 also has many mutations on the spike protein. But BA.2 has some different mutations from BA.1. According to U.K. Health Security Agency, BA.2 has about 120% growth advantage over BA.1. Currently BA.2 accounts for 50% new cases in Denmark and is a dominant variant in India. Will BA.2 cause another surge in US and in the world? Would BA.2 cause more severity than Omicron 1? Is the immunity gained from BA.1 effective in preventing infection by BA.2? These questions do not have clear answers yet. But the medical experts do believe that the vaccines ( manufactured by Pfizer/BioNtech, Moderna and J&J) should still be effective in prevent serious illness caused by BA.2..
1/19/2022: According to research results published in the Journal of American Medical Association Internal Medicine on Dec 6, 2021, cataract removal is associated with lowing the risk for dementia among older adults by 30%. The data were collected from 1994 to 2018 from 3098 participants of 65 years or older, with controlling for numerous demographic and health risks. The participants did not show onset of dementia at the beginning of the study.
Some of the limitations of this study are that the participants are mainly white and only the impact of one eye cataract removal was studied. It is unknown if the cataract removal of the other eye will have an impact on dementia or not. It is also unknown how exactly cataract removal impacts on lowing the risk of dementia.
1/12/2022: According to Nature Briefing, regarding COVID-19 infections caused by Omicron variant, though the antibody induced by the vaccines is not effective enough to prevent the infection, ‘killer’ immune T cell from the COVID-19 vaccines or natural infections is playing an important role in removing the infected cells by Omicron. T cells can limit the spread of infections and reduce the chances of serious illness. Research groups found that the majority of sites that T cells recognize are present in Omicron variant. Therefore, the T-cell responses should remain quite strong against Omicron variant. The effectiveness of Pfizer-BioNTech and J&J’s vaccines at preventing hospitalizations in the current COVID-19 surge is likely due to the protection from the T cells.
1/5/2022: There is a silver lining in the surge of COVID-19 due to the Omicron variant. According to New York Times, though a higher number of people are hospitalized, a smaller percentage of them need intensive care or a mechanical inhalator. This phenomenon maybe partially because Omicron is less prone to infecting the lungs; and maybe partially because now the population has developed some immunity either due to vaccinations or previous infections. A high majority people in ICU are either unvaccinated or their immune systems are severely compromised. With the current available data, it is estimated that ~15% of Omicron infected people need to be hospitalized, comparing to 43% of Delta infected patients and 55% of Alpha infected patients need to be hospitalized.
12/23/2021: This week FDA approved Pfizer’s anti-virus pill Paxlovid for treating COVID-19 under emergency use authorization (EUA). Paxlovid, for oral use, is a co-packaged medicine of two tablets of Nirmaltrelvir pill and one tablet of Ritonarvir. Nirmaltrelvir inhibits the virus’ protease enzyme and therefore prevents the virus’ replications. Ritonarvir inhibits human liver cytochrome enzyme that can break down Nirmaltrelvir so that Nirmaltrelvir can stay longer in the body at the level to fight the virus.
Paxlovid, once prescribed, it needs to be taken twice daily for a total of five days. This drug should be used for the people who are 12 years or older and have a high risk to develop a severe illness, after positive test result of COVID-19. This drug should be used as soon as possible after diagnosis and within five days of symptom onset.
FDA also approved Merck’s anti-virus pill Mulnupiravir under EUA. There are far more restrictions on Mulnupiravir. Mulnupiravir is only used when other COVID-19 treatment Is not available. Pregnant woman should not use it. Men who use it should use birth control for three months.
12/18/2021: According to The Washington Post, the monoclonal antibody, Xevudy (generic name sotrovimab), invented by Vir Biotechnology and GlaxoSmithKline, is expected to be very effective against the highly transmissible COVID-19 Omicron strain.
Very interestingly this antibody was isolated from a patient two decades ago who recovered from severe acute respiratory syndrome (SARS) virus. This antibody can block SARS and SARS-Cov-2 (which causes COVID-19). Uniquely this antibody latches onto a region of SARS-COV-2 virus spike protein that is not likely to change. So, this antibody is expected to be effective against various variants including Omicron variant.
Currently, the supply of Xevudy is limited, ~50,000 doses available. These doses are preserved to fight against the Omicron variant. The company is planning to increase the capacity to ~2 million doses.
Existing antibody treatments from Eli Lily and Regeneron work effectively against the Delta variant. They may lose efficacy against Omicron variant.
12/10/2021: Almost everybody is interested in anything that can slow down aging. Common things people can do to slow down aging include eating healthy, exercising regularly and doing some intellectual hobbies to keep brains stimulated. Certainly, please keep doing these nice things. Recently, there is a very interesting news report that hyperbaric oxygen therapy improved the length of telomere by 20%. Telomere is a piece of DNA-protein capped at the end of each chromosome. Telomere shortens with aging. When telomere becomes longer, it is almost like reversing the aging clock! While this news could be very exciting, it also causes concerns in other medical experts. Please share your thinking in the Chat Room of Hyperbaric Oxygen Therapy after you login. Here is the link for the news report https://www.timesofisrael.com/israeli-scientists-claim-to-reverse-aging-in-blood-cells-with-pressure-chamber/.
12/02/2021: To many people, a cup of freshly brewed hot coffee in the morning help them to get energized for the day. Have you ever thought that coffee can stimulate bowel movement and can help to treat constipation? According to NY Times, the mechanism of this is likely through the communication between the stomach, brain, and colon, called gastrocolic reflex. Dr. Martindale, a professor of surgery and director of hospital nutrition services at Oregon Health and Science University often offers his patients a cup of coffee after their surgeries to help them to recover the bowel movement faster. At this time, it is not sure which chemical in coffee’s 1000 compounds is triggering the reflex. It does not seem to be caffeine that is doing this because both regular coffee and decaffeinated coffee can have this effect. Whichever chemical is causing this, now there is another reason to drink coffee besides the benefits of its antioxidant and anti-inflammatory properties.
11/28/2021: According to NY Times, Vertex Pharmaceuticals is performing a phase 1 clinical trial to inject pancreatic islet cells (that generates insulin) into Type I diabetic patients. The pancreatic islet cells are prepared from embryonic stem cells. To prevent the body’s immune system to reject the injected cells, patients are given an immuno suppressing drug. One patient, Mr. Shelton, a Type I diabetic patient for decades, was able to maintain his blood glucose level at a normal level after the injection. The result is amazing, and this is a great news for Type I diabetic patients. Since this is only a phase I trial, more data need to be collected to show if repeated injections are needed to maintain the normal blood sugar level and if there are any adverse effects from the cell injections.
11/27/2021: Omicron, B.1.1.529 variant from South Africa, has been detected in Belgium, UK, Germany, Italy, Hong Kong and Israel. The virus has 32 mutations on the spike protein that is the target for existing vaccines and antibody treatments. In comparison, the delta variant has half of the number of mutations. Therefore, there is a risk that the current vaccines and antibody treatments may be less effective. However, it is still too early in understanding if the new variant will be more transmissible and more deadly.
BioNTech said it would know in two weeks whether its current vaccine works against the variant or not. Moderna is planning to advance a booster vaccine candidate specifically for the new Omicron variant.
11/22/2021: The number of COVID-19 cases in US is rising again as the winter sets in and holiday season is getting close. We know that the cases mostly comprise unvaccinated people. How about breakthrough infections? We probably wonder what the reality is. Wall Street Journal reported yesterday that 1.2% of fully vaccinated people have had a breakthrough case; vaccinated people with diabetes, chronic lung disease, kidney disease and compromised immune system are still at risk. LA county’s public health department reported unvaccinated people are nearly 5 times more likely to get COVID-19 and about 29 times more likely to be hospitalized than fully vaccinated people. The likelihood of hospitalization for people with breakthrough cases but without underlying health conditions was about 7.5%.
To curb the continual uprising of COVID-19 cases, getting booster shots and improving overall vaccination rate is the best way. FDA and CDC authorized emergency use for booster shots to all adults six months from their second vaccine dose. In the COVID-19 Chatroom at this website after you log in (among the Chatrooms for Health Conditions and Treatments), there are a couple of very interesting and helpful posts (posted recently) that discussed the types of antibodies from the three approved vaccines and the natural infection, how long they last and if the antibody levels is an accurate way to indicate the level of immunity from the vaccines.
11/2/2021: CDC announced this afternoon to endorse FDA’s authorization of Pfizer/BioNtech COVID-19 vaccine for emergency use in children of age 5-11. Children of this age group could get COVID-19 vaccine as soon as this week. Though there could be some side effects, benefits are much higher than the risks. The potential side effect is myocarditis (swelling of heart muscle) that has been seen particularly among young men. Infection with COVID-19 can cause myocarditis, that is more serious than myocarditis caused by vaccine. COVID-19 has already caused substantially more sickness in children than other childhood diseases.
10/20/2021: A very good news for the people who need transplant of an organ. A kidney grown in a genetically engineered pig was successfully transplanted in a trial to a patient who was brain dead. The kidney started to work right away. The procedure was performed in NYU Langone Health, directed by Dr. Robert Montgomery. Though this transplant was outside of the body, it is expected that when transplanted to inside of the body, it should work too.
This success is considered a major milestone by many medical experts in this filed, though longevity of the kidney still needs to be known. This opens the opportunity for many desperate patients who need kidney transplant. The pig kidneys could be used to patients as soon as in months. This approach also opens opportunities for transplanting other organs, such as heart, lung, liver and etc.
10/4/2021: Today, FDA approved ACON’s home testing agent, FlowFlex, for COVID-19 testing. This will be sold as an over-the-counter test. This approval will double the supply for non-prescription tests for COVID-19. On a separate note, Moderna and J&J are applying to FDA for the booster shots authorization of their COVID-19 vaccines. FDA advisory committee panel will review and provide recommendations on these two applications on Oct 14 and Oct 15 respectively.
9/24/2021: Today, Dr. Rochelle Walensky, the CDC Director, overruled some of the CDC advisory panel’s recommendations about who will be eligible for Pfizer/BioNtech’s booster shot. Dr. Walensky’s decision is more aligned with FDA’s authorization to allow booster shots for the front-line workers, including health care workers, teachers, others whose jobs put them at a higher risk. So, this group of people will be eligible to receive booster shots in addition to the people who are 65 years and older and other adult people who have high risk to COVID-19 due to their underline health conditions.
9/20/2021: Today Pfizer and BioNTech announced its clinical trial data of its COVID-19 vaccine for the age group of 5-11 years old. The data shows at one third of the adult dose, the antibody response and side effects in this age group, are comparable to the results of the age group of 16-25. A lower dose for the 5-11 age group is for lowering the potential side effect, myocarditis, which has been seen in adults.
Pfizer is planning to apply to FDA for authorization of the use of the vaccine for the age group of 5-11. This is a great news for the parents who worry about their children in this age group who might get infected with the delta variant.
9/14/2021: Booster or not booster shots for the people who have been fully vaccinated? This is certainly a controversial topic currently. On one hand, booster shot will increase the amount of antibody and therefore will increase the body’s defense to fight against COVID; on another hand, so far, there is no data suggest fully vaccinated people need a booster shot yet. Even though the amount of antibody is decreasing with time, the body’s memory cells and T cells should stay for a long term that can continue to fight against the delta-variant.
Two other considerations against the booster shots to be given in the near future are the potential side effects from the third shot and taking the vaccine supply from vaccinating the people who have not been vaccinated yet, especially in developing countries. Currently, there is an urgency to vaccinate the unvaccinated people than giving the third shot to the vaccinated people.
8/31/2021: The European Union yesterday removed the US from its list of countries for lifting non-essential travel restrictions. It allows its member countries to decide its own restrictions. It is still expected that fully vaccinated Americans should still be allowed to travel to Europe without quarantine requirements.
On a separate note, there is a good news that a pivotal phase 3 clinical study performed by Sanofi and Regeneron on their drug Dupixent in combination with standard of care topical corticosteroid show good efficacy results in treating severe atopic dermatitis in children aged between 6 months and 5 years. The study results show the drug significantly reduced overall disease severity and improved skin clearance, itch and quality of life compared to the topical corticosteroid group.
8/21/2021: While people who receive mRNA COVID-19 vaccines made by Pfizer or Moderna will be able to get a third booster shot from Sept 20, how about the people who got the J&J Vaccine (an adenovirus vaccine)? J&J’s researchers said the antibodies generated by their vaccine last for at least 8 months and they are now studying if people should get another shot of the same vaccine as a booster.
The other possible option for the people who got the J&J vaccine is to get another dose of mRNA vaccines as a booster. Health officers in San Francisco are providing another shot of Pfizer or Moderna’s vaccine to the people who got the J&J’s vaccine. Germany has been doing this way too to provide people who got AstraZeneca’s vaccine (also an adenovirus vaccine) with another dose of Pfizer’s vaccine.
It is expected that health officials of FDA and CDC will provide a clearer guidance in the near future regarding a booster shot for the people who got the J&J’s vaccine.
8/12/2021: On his interview with CNBC, the former WHO epidemiologist Dr. Larry Brilliant said that the coronavirus delta variant is the most contagious virus ever known. The good news is that the Pfizer's and Moderna’s vaccines are still effective against the delta variant. COVID-19 will not be under control until most people in every 200 countries are vaccinated. Though the possibility of a super variant that would evade the vaccines may be low, the world should try the best to prevent it. Dr. Brilliant also recommends that people at 65 years or older who were fully vaccinated 6 months ago should get a third shot as soon as possible.
8/5/2021: According to Reuters, with the new cases of COVID-19 surging in the US due to the delta variant, CDC is considering to allow an additional booster shot for the people who are immunocompromised. In order to do that, the vaccines will need to be fully approved or FDA has to amend the Emergent Use Authorization.
A silver lining to the current COIVD-19 cases surging is that more Americans are seeing the need to get vaccinated. In the past 24 hours, 864,000 vaccination shots were administered, the highest rate since early July.
7/16/2021: According to New York Times, the new cases of COVID-19 in the US has reached 51,891 with a seven-day average of 30,704 due to the spread of delta variant of COVID-19 . This is the highest seven-day average since May 19, 2021. The states with top 5 highest numbers of COVID-19 cases are Florida (16,730), Texas (4,682), California (4,599), Missouri (2,818) and Kansas (1,965). Most of the new COVID-19 cases, hospitalizations and deaths are among unvaccinated people. As the Director of CDC Rochelle Walensky put it “ This is becoming a pandemic of the unvaccinated”.
The benefits of being vaccinated, besides protection from COVID-19, it will also make it possible to travel overseas. According to Washington Post, Canada could open to American fully vaccinated tourists as early as mid-August and open to other countries’ vaccinated tourists by early September.
7/1/2021: According the CNN interview of US Surgeon General Dr. Vivek Murphy, the unvaccinated people are in trouble with the spread of Delta variant of COVID-19 in the US. Currently ~26% of the new cases are due to the Delta variant. Pfizer/BioNTech and Moderna COVID-19 vaccines are highly effective in preventing being infected by the Delta variant. It is not known how effective the J&J COVID-19 vaccine is against the Delta variant. Dr. Murphy is hopeful that the J&J vaccine should be effective in preventing hospitalization and serious illness.
6/18/2021: US government is planning to invest 3.2 billion dollars on development of therapeutical drugs against COVID-19. Part of the fund (2 billion) will be used for research and lab support, preclinical and clinical evaluations, development and manufacturing. The remaining 1.2 billion will be used to buy 1.7 million courses of Merck’s drug molnupiravir, if it is approved by FDA. Molnupiravir is currently in phase 3 clinical trials. Merck is currently working on production and plans to have 10 million courses ready by the end of 2021. While vaccination is playing a major role in controlling the spread of the virus, therapeutical drugs will be very important for treating the people who are infected with COVID-19.
6/7/2021: Today, the US FDA approved the controversial Biogen drug Aduhelm for the treatment of Alzheimer’s Disease, a debilitating disease impacting 6 million Americans. It is the first new drug approved for Alzheimer’s since 2003 with the mechanism to reduce amyloid plaque, which is one of the claimed underlying cause for Alzheimer’s disease. It represents a first-of-its-kind treatment approved for Alzheimer’s disease. Some experts do not agree with the approval of the drug due to the doubts on its efficacy.
5/28/2021: Today, the US FDA approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer. It is for a type of genetic mutation called KRAS G12C. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers.
5/23/2021: According to Bloomberg, US CDC is speeding up the surveillance of the Indian COVID-19 variant in the US. Currently, it is below 1% in all the diagnosed cases. However, in the states or areas of low vaccination rates, this variant may represent a risk because it transmits about 50% faster than the UK strain that currently dominates in the US. In addition, according to The Week, a study by Public Health England shows the Pfizer-BioNTech COVID-19 vaccine is 88% effective against the India variant after two weeks of the second dose of the vaccine. This result provides more confidence about the effectiveness of the vaccine against the Indian variant.
5/10/2021: According to Reuters, for the COVID patients who are seriously ill and hospitalized, a combination of the new monoclonal antibody (Lenzilumab by Humanigen) with steroid and Remdesivir can improve survival by 92% without the need of mechanically invasive ventilation. This should represent a significant achievement for treating the seriously ill patients and potentially save their lives.
5/5/2021: Researchers in Australia have found that chronic kidney disease caused by high sodium diet could be helped by an enzyme called NEDD4-2. Worldwide, there are about 700 million people (10% of the population) who have chronic kidney disease. NEDD4-2 regulates the re-absorption of sodium in kidney. When the level of NEDD4-2 is low, high level of sodium re-absorption can result in kidney damage. If a drug can be found to increase the level of NEDD4-2, it should be helpful in treating the chronic kidney disease.
4/26/2021: According to Associated Press, a California man in his 30s experienced lower back pain and leg pain after 13 days of having the J&J’s COVID-19 vaccine due to the rare blood clot. He was treated in University of California, San Francesco and should be discharged in a few days.
4/23/2021: According to CNBC news, CDC advisory committee today has recommended to resume the use of J&J’s COVID-19 vaccine after a 10-day pause. Among the almost 7 million doses administered, totally 15 cases of rare blood clotting (including 12 women) happened resulting in three women’s death. The panel also proposes to FDA to put a warning label for the vaccine for women younger than 50 years old. With the CDC’s recommendation, US FDA could lift the pause as early as this weekend.
4/21/2021: A simple chemical, sodium benzoate was shown in a small trial to improve the cognitive function of women patients with late-stage dementia. Larger trials will be needed to confirm these results. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779038?utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamanetworkopen&utm_content=wklyforyou&utm_term=042121
4/20/2021: European Medicines Agency (EMA) supports to resume J&J’s COVID-19 vaccine roll out after a pause since last week. The rare blood clots plus lower platelet level is possibly caused by an immune response to the vaccine carrier, adenovirus. Since AstraZeneca’s vaccine is also carried by an adenovirus, it has the similar rare side effects of J&J’s vaccine. EMA considers the benefits of the vaccine far outweigh the risks. https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-finds-possible-link-between-jj-covid-19-vaccine-blood-clots-2021-04-20/
4/18/2021: According to Politico, Dr. Antonin Fauci said today that he believes J&J vaccine will come back for use “in some form”, though the label may carry some restriction/warnings. The CDC advisory committee is going to meet by the end of next week and a decision is expected from that meeting.
4/11/2021: The Astra-Zeneca/Oxford vaccine has been in the news for its potential to cause blood clots. These are rare events, but importantly, in younger women. There has been some thought that it may be in those who use birth control pills. It is also important to note that the other vaccines also have clotting problems. https://www.nytimes.com/2021/04/10/health/astrazeneca-vaccine-blood-clots.html
4/11/2021: Recently Oncologists have found that the patients’ diet is important while administering certain cancer therapies. Tailoring the diet for different cancer medications could become important in the future.
4/03/2021: Today a record 4 million doses of COVID-19 vaccine was administered in the US. By now, around 104 million American people have received at least one dose of COVID-19 vaccine. Totally 161 million doses of COVID-19 vaccines have been dosed in the US.
4/03/2021: As a one-dose vaccine and only requiring refrigerated storage, J&J COVID-19 vaccine is considered as a game changer in combating the pandemic. An initial of 5 million doses were distributed in the US in late February and March. Though one contract manufacturer (Emergent BioSolutions) at Baltimore, MD, made a mistake in mixing up the ingredients that ruined about 15 million of doses, another contract manufacturer, Catalent at Bloomington IN is in process of delivering tens of millions of doses in US. Later this year, Merck is expecting to produce J&J’s vaccine. J&J is expecting to deliver 100 million doses to the US by the end of May.. J&J’s vaccine is also making an impact in other countries. South Africa and Germany are planning to have millions of doses in near future.
3/31/2021: Bristol Myers Squibb and its partner Bluebird bio received approval from the U.S. FDA on March 30th for a multiple myeloma treatment called Abecma, a CAR T (chimeric antigen receptor T cell) therapy. During a pivotal phase II clinical trial of 127 patients, the overall response rate is 72% for efficacy evaluable patients while 28% patients achieved a stringent complete response.
3/29/2021: CDC reported that the Pfizer and Moderna vaccines proved to be very effective in real-world scenarios in preventing COVID-19 infections.