Paper and Threads

There are 5 Covid-19 Vaccines in Phase 3 Clinical Trials.  Two of them may apply for an Emergency Use Authorization (EUA) within the next one or two months.  Moderna has completed enrollment of 30,000 volunteers - half in the placebo and half in the treatment group.  They slowed their enrollment briefly several months ago in order to enroll more persons of color, patients 65+, and volunteers with comorbidities. Pfizer has enrolled 42,000 out of their goal of 44,000 and they have added a group of volunteers between 12 and 18 years old.  Each company has an independent Data Safety Monitoring Board, scientists who will analyze the data when a target number of volunteers have developed Covid-19. 

The Board will initially review the data without knowing who received the vaccine and who received placebo.  Then hey must be able to demonstrate at least 50% efficacy when comparing Covid-19 cases in the vaccine and placebo groups, and no serious side effects. In order to evaluate safety both companies must wait for two months after at least half of the volunteers have received both vaccine doses before applying for approval from the FDA.  Continue Below

They can then apply to the FDA for an Emergency Use Authorization or a Biologic License Approval. EUA are usually reserved for instances in which there is proven efficacy and minimal adverse effects and the benefits must outweigh the risks.  However when EUAs are granted, there is a substantial chance that the the clinical trial will not continue for the full 24 months of followup.  There was discussion at the FDA meeting that the company might want to vaccinate the placebo group right away, thereby ending the Randomized Placebo-Controlled trial that would provide definitive data for efficacy and long term safety.

The public rarely knows as much about the development of a vaccines - the fastest vaccine took 4 years to make, test, and distribute.  But we all want very effective and safe vaccines, and the companies are not willing to rush through the requirements.  A Biologic License Approval takes longer to assess and approve and with the current surge in cases many more people would die.  Difficult decisions must be made.

Posted by Shirley at 5:59 AM | Permalink | Comments (0)

The production of infectious aerosol droplets can vary widely between people. If you look at people expire in cold weather you can see that the size of their breath cloud varies considerably when exhaling. Aerosol droplets are created in the bronchioles of the lungs, the larynx, and the mouth. The shapes of the body, loud talking, and breathing fast all have a major role in spreading the droplets.

Shouting amd singing, especially in Karaoke Bars, have been a big source of superspreading events.  At least forty adults were infected on Aug. 23rd at a Karaoke Bar in Quebec City and then they passed it along to 10 family members. 

An aerosol is any particle that can be suspended in air for minutes to hours - and are usually less than 100 micrometers in size. The respiratory fluid in the lungs create a film that bursts like soap bubbles as the bronchioles and larynx expand and contract. All the aerosols and droplets are trapped in an explosive puff of gas which carries them into the air. Superspreaders produce an order of magnitude more than other people even when talking. This may be due to variations in the thickness of their respiratory fluid. This field of science is difficult but advancing rapidly during the SARS-CoV-2 epidemic. (National Geographic October 2020)

Posted by Shirley at 7:21 AM | Permalink | Comments (0)

Vaccine hesitancy is defined as lack of acceptance or refusal of vaccination despite availability.  Herd immunity, which could control the pandemic, occurs when 60-70% of the population have antibodies against the virus.  Covid-19 infections have produced natural immunity in only 10 % of the US to date.

That means that we still need vaccination to achieve immunity in 60-70% of the population.  Recent surveys demonstrate that 70% of those who would accept a vaccine last spring has dropped to near 50% of people who now will be vaccinated. 

If only 50% of people will be vaccinated, and the vaccine may only be 50-60% effective, vaccination will only increase immunity to 25-30% of the US.  After digesting these numbers it becomes apparent that we will only have 10% + 30% = 40% toward herd immunity, and more people need to be willing to be vaccinated.  One of the lectures at the FDA Hearing last week presented reasons why more patients now have vaccine hesitancy.  See Below.

In a Reagan-Udall Foundation supported study, researchers discovered that there were multiple reasons for vaccine hesitancy:

1.  The speed of vaccine development raised questions about vaccine safety.

2.  There is distrust of the Government, FDA, WHO, and health-care systems.

3.  There is worry about a political and economic priority over science.

4.  Vaccines may not "work for me" - my group hasn't been included in the Clinical Trials (race, age, and comorbidities).

5.  There is fear among Blacks because of the old government Tuskegee Experiments in which black men were not treated for syphilis so the course of the disease could be studied by the government. 

Much work needs to be done to allay these fears in the next 6 months. 

Posted by Shirley at 7:32 AM | Permalink | Comments (0)

The Vaccines and Related Biologic Products Advisory Committee of the FDA (VRBPAC) Hearing: 

Members of this big committee are from academia: virologists, pediatricians, epidemiologists, and career scientists of NIH, CDC and FDA. The Committee held an open meeting online on Thursday in order to present extensive information about the coronavirus, Covid-19, the role of the NIH in vaccine development and testing through Operation Warp Speed, the Vaccine Safety Team, problems of vaccine hesitancy, and criteria for Emergency Use Authorization and/or Biologic License Approval.  It was a full 8 hour meeting and enormous amounts of information were presented to the above committee and the public.  This was a way to make everything about the development of vaccines transparent and I watched all 8 hours.  Read Below.

This was not a meeting about specific vaccines being developed in the US.  It was a meeting to review the criteria that all vaccines must meet in order to apply for approval - based on an October 2020 document publishing the revised criteria for efficacy and safety.  I know that both Moderna and Pfizer/BioNTech are near the end of enrollment (30,000 and 44,000 volunteers of different ages, races, comorbidities).  But companies can't present data re: efficacy and safety until at least 50% of the volunteers are 2 months beyond their 2nd dose of vaccine   Each vaccine must be at least 50% efficacious, have 5 or more placebo patients with severe disease. and not have serious adverse effects.  I feel much better about the scientific rigor that will be required and I hope that both vaccines are able to meet all of the criteria outlined.   

Posted by Shirley at 7:54 AM | Permalink | Comments (1)

There is still a need for further clinical studies on the effect of SARS-CoV-2 on pregnancy.  In general it is recommended that women follow all the public health safety measures to prevent getting Covid-19 at all during pregnancy.  The studies show that Covid-19 is slightly more severe during pregnancy and there is a higher incidence of ventilators.  But there is no increase in mortality.  There is only very rare transmission of the virus to the babies, and it is not clear whether that occurred prior to or after delivery.  The babies rarely have problems due to the virus and it is not transmitted in breast milk. Mothers who want to breast feed are recommended to perform strict hand washing and mask wearing while feeding the babies. Read Below. 

Doctors at NYU Hospitals in New York studied 149 mother-child dyads and it is one of the largest studies published to date.  Forty% of the mothers were asymptomatic and picked up on screening.  15% of the symptomatic mothers required some type of respiratory support.  Symptomatic mothers had a significant increase in preterm births ( 16% vs 3%  P=0.02).  Only 1 newborn was + for SARS-CoV-2 and that was believed to have happened post-partum.  There were 3 sets of twins, 3 still births, and 1 post-natal death. (Publication in Pediatrics journal this month).

Posted by Shirley at 8:29 AM | Permalink | Comments (0)