News Updates

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. 

https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug?utm_medium=email&utm_source=govdelivery


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.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug?utm_medium=email&utm_source=govdelivery


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.

https://www.technologynetworks.com/biopharma/news


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.