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Let’s face it, a realistic target for a Coronavirus vaccine is 2021 (or later)

There has been a lot of talk about how “we” are making a lot of progress in creating a coronavirus vaccine lately, and it’s getting irresponsible.  Yes, the Phase 1 and Phase 2 trials are going fine, but these tell us almost nothing about effectiveness.  Phase 1 and 2 trials are meant to test a drug’s safety and to explore the effects at different dosing levels, but they are not useful in determining a vaccine’s overall effectiveness.  Only the much larger, Phase 3 trials (usually randomized, blinded studies, in very large numbers of patients, studied over time) tell us how effective a vaccine will be in preventing a disease.

So far, we have all heard the press releases showing that Moderna’s experimental  vaccine has shown an antibody response in patients (yes, that was eight).  First of all, 8 patients is nothing in terms of a clinical trial.  It would have been more responsible to report that the Phase 1 trial showed that the drug was “safe enough to proceed on to further trials.”   Second of all, showing an antibody response (in this case, production of “neutralizing antibodies”) does NOT tell us that these patients will be protected against infection.  It is known that coronavirus infection causes production of multiple types of “neutralizing antibodies” (the June 2020 issue of Science magazine has an article documenting this) and it is not known what levels of which antibodies might be protective.

Viruses and bacteria often cause multiple types of antibody production, and the term “neutralizing antibody” implies that having it will prevent infection, but this is not necessarily true.  Hepatitis B virus infection, for example, is known to cause production of multiple antibodies (to “core” antigen, “early” antigen, and to “surface” antigen) but only 1 of them (so-called “surface antibody”) demonstrates protection against the infection.   This is also a problem with all of the antibody tests that received emergency approval from the FDA – no one knows what antibody will be protective, and they may all be measuring different antibodies.  It is well-known that having a positive antibody test does NOT confer long-term protection in everyone who is positive.

There have been other vaccines (for example, an earlier version of Rotavirus vaccine, and most recently Dengvaxia, for Dengue virus) that were approved too quickly, and had very significant negative effects because they were not studied long enough in certain populations.  The U.S. withdrew the earlier Rotavirus vaccine in less than a year, and the Philippines did the same with Dengvaxia after a huge number of pediatric deaths.

Additionally and most importantly, once a vaccine is shown to be safe and effective and approved for use, then it must be produced in huge volume and distributed to the world’s population.  There is no quick way to make billions of doses of a vaccine, and it is almost certain that one will need 2 or 3 doses (or more), each separated by 1-2 months (or more) for adequate protection.  Since more than 1 company, in more than 1 country, may develop effective vaccines, there will need to be international cooperation in licensing and distributing the vaccine(s).  Everyone will feel that they are a priority.  It is sure to get ugly, especially in this era of extreme nationalism and leadership by rant and tantrum.

The big message?  4-6 months (at best) until vaccine approval; 1-6 months to ramp up production/distribution; and 2 doses (at least) separated by 1 month (or more).  That means reasonably a full year before anyone gets a second dose.

P.S. There aren’t even any trials testing the vaccines against children yet…


Fear of COVID leading to healthy kids missing out on necessary vaccines

Covid-19 Pandemic Scares Many Away From Routine Pediatric Visits

During the first few months of the Covid-19 crisis, many patients, especially parents with young children, canceled routine doctor visits.  This is understandable, as very little was known about the virus and its transmission.  Indeed, many doctor’s offices essentially shut down and offered urgent care only, or referred their patients to hospital emergency departments.  Unfortunately, the result of this was that many young children missed appointments in which they should have received essential vaccinations and now many children are behind on their shots.  This unintended consequence of postponing routine care may wind up causing outbreaks of some of the more contagious diseases that we have not seen much of in many years, such as measles, pertussis and chickenpox.  PLEASE, if you have a child who has missed out on vaccination visits this year, especially a child under 2 years old, call your pediatrician’s office to discuss ways to get caught up on your child’s vaccines.

New hexavalent (6-in-one) vaccine coming in 2021

There’s a new vaccine coming to the US which will save shots for infants, but it won’t be in use until next year.

A new-ish vaccine is coming to the US next year which will decrease the number of shots needed at 2, 4 and 6 months of age.  It was actually approved for use in the US in 2018 but due to production and marketing reasons, it will not launch here until 2021.  Also, because it is only licensed for use in the first 3 doses of these vaccines, it will have a limited impact on most babies.

Vaxelis, produced by the MCM Vaccine Company, will protect against Hepatitis B, Haemophilus influenza type B, polio, diphtheria, pertussis (whooping cough) and tetanus.  It is licensed for use at 2, 4 and 6 months of age but NOT at 15 months, when many infants need boosters of several of these components.  The net effect is that for pediatric practices using this new vaccine, babies will get 1 or 2 fewer injections compared to the previous routine.  But since the use is only at 3 ages, the impact will be limited.  Still good news, as less shots providing the same protection is always good!

An interesting tidbit here is that “MCM Vaccine Company” is a joint venture between Merck and Sanofi Pasteur, 2 giants in the vaccination field.  This will be their first joint venture.

Acute Flaccid Myelitis (not a vaccination topic – yet)

Many of you have heard about the mysterious cases of acute flaccid myelitis (AFM) that have been occurring around the country for the past several years.  It is a polio-like condition that causes sudden-onset of weakness of an arm or a leg or other muscles.  Sometimes the weakness involves breathing muscles or the face.  Sometimes the severity is so bad that it causes difficulty with breathing and necessitates hospitalization.    Afterwards, in most victims the weakness goes away; in some it is permanent.  As a result, these are a lot of pediatric neurosurgeons getting experience with nerve transfers (moving a nerve ending from one place to another), to try to restore some movement to a permanently damaged arm or leg.

The CDC was oddly quiet about this condition for the first few years after it started being recognized.  There seemed to be a pattern of an increased number of cases every 2 years (in the even-number years) with less cases in the odd years of 2015 and 2017.  This year there have been more cases identified than in any past years (it is unknown if this is because of more cases or more awareness).  This illness is NOT caused by polio virus but many of the symptoms are similar to polio.  Some cases of AFM seem to be associated with different strains of enteroviruses, which commonly cause respiratory illness in the U.S. , especially in the “cold and flu” season.  No definitive cause has been determined, and many studies are ongoing.

Here’s a related blog article from The Pediatric Insider:

See more the the CDC’s AFM web page:

Influenza – January 2019 update

For the week ending 12/29/2018, the CDC is reporting an uptick in influenza-related illnesses all over the U.S.  So far, there has been a good match between circulating strains of influenza and the strains included in this year’s vaccines.  The CDC releases new data on influenza and related illnesses weekly during the influenza season.

There is still time to get vaccinated against influenza and getting vaccinated is highly recommended!!

The information below is taken directly from the CDC website:

  • Viral Surveillance: The percentage of respiratory specimens testing positive for influenza viruses in clinical laboratories is increasing. Influenza A viruses have predominated in the United States since the beginning of October. Influenza A(H1N1)pdm09 viruses have predominated in most areas of the country, however influenza A(H3) viruses have predominated in the southeastern United States (HHS Region 4).
    • Virus Characterization: The majority of influenza viruses characterized antigenically and genetically are similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses.
    • Antiviral Resistance: All viruses tested show susceptibility to the neuraminidase inhibitors (oseltamivir, zanamivir, and peramivir).
  • Influenza-like Illness Surveillance:The proportion of outpatient visits for influenza-like illness (ILI) increased to 4.1%, which is above the national baseline of 2.2%. All 10 regions reported ILI at or above their region-specific baseline level. The increase in the percentage of patient visits for ILI may be influenced in part by a reduction in routine healthcare visits during the winter holidays, as has occurred during previous seasons.
    • ILI State Activity Indictor Map: New York City and 19 states experienced high ILI activity; nine states experienced moderate ILI activity; the District of Columbia and 10 states experienced low ILI activity; and Puerto Rico and 12 states experienced minimal ILI activity.
  • Geographic Spread of Influenza: The geographic spread of influenza in 24 states was reported as widespread; Puerto Rico and 18 states reported regional activity; six states reported local activity; the District of Columbia, the U.S. Virgin Islands and two states reported sporadic activity; and Guam did not report.
  • Influenza-associated Hospitalizations A cumulative rate of 5.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population was reported. The highest hospitalization rate is among children younger than 5 years (14.5 hospitalizations per 100,000 population).
  • Pneumonia and Influenza Mortality: The proportion of deaths attributed to pneumonia and influenza (P&I) was below the system-specific epidemic threshold in the National Center for Health Statistics (NCHS) Mortality Surveillance System.
  • Influenza-associated Pediatric Deaths: Two influenza-associated pediatric deaths were reported to CDC during week 52.

A New Combination Vaccine for Infants and Toddlers – fewer shots!!

The FDA just approved a new combination vaccine for routine use in infants and toddlers that can decrease the number of injections given down to just 2 at a time for infants at 2, 4 and 6 months.  This is great news – we are all in favor of getting the same protection for our patients from fewer injections.  Fewer shots=less pain (and hopefully less crying).

The new product is called Vaxelis (as I have said before, there is apparently no budget for catchy, meaningful, or simple names for new medications).  It was co-developed by Merck and Sanofi, both of which make many vaccines for both children and adults.  The new product can be used at 2, 4 and 6  months of age (as well as for catch-up vaccination) and will protect against Diphtheria, Pertussis, Tetanus, Haemophilus influenza type B, Hepatitis B and Polio.  There are already multiple combination products on the market but this is the first 6-in-1 combo to be approved for use in the U.S.  A pediatric office using this vaccine will be able to give as few as 2 injections (Vaxelis and the Streptococcus pneumoniae vaccine called Prevnar) to infants at their 2, 4 and 6 month well visits.

The decision of whether to use a newly approved vaccine lies with both the local decision-makers for a particular pediatric office as well as with a state’s public health vaccination program (often run through the VFC, or Vaccines for Children Program).  If an office gets its vaccines through a state’s VFC, it will usually purchase many or all of  the same vaccines for use in patients who do not use the VFC program, to simplify vaccine ordering, record-keeping and storage.

Hooray for the FDA!  Hopefully our government shutdown does not slow the decision-making at VFC on whether to include Vaxelis in their product line.

Ongoing Chickenpox Epidemic in a North Carolina School – November 2018

A school in North Carolina is currently experiencing a months-long epidemic of cases of chickenpox.  Part of the Waldorf Schools chain, the school (the Asheville Waldorf School, in Asheville, NC) apparently was long known for having a large proportion of its students unvaccinated.  The school’s proportion of unvaccinated students was among the highest in North Carolina, according to reports.  

North Carolina law requires that school students be vaccinated, BUT allows medical exemptions (such as in the case of an allergy to a vaccine component) as well as “religious” exemptions, although there are no major religions in the U.S. that object to vaccination.  In fact, most have voiced strong support for vaccination, which is widely accepted as keeping children healthy.  As you can see below, the “religious exemption” apparently has nothing to do with religion per se, but only requires parents to write a note that states their religious beliefs and their objection to vaccinations.  

This is taken verbatim from the Asheville Waldorf School’s website in the section on immunization:

Immunization Records: Each child must have a completed health and immunization form on file before being admitted.  This is a requirement of the county health department and state law.   NC law provides for the following two exemptions:  1. Medical exemption in which a licensed physician certifies in writing that an immunization may be detrimental to a person’s health. A form for this is available.  2. Religious exemption in which the parents submit a written statement of their bona fide religious beliefs, and opposition to the immunization requirements, after which the child may attend the School without presenting a certificate of immunizations.

The school has apparently been experiencing an ongoing chickenpox outbreak since September; however as of last week (2 months later) they had still failed to control it.  

This is from the school’s newsletter to all parents dated 9/26/2018: 

Dear Parents and Guardians,

We are writing to inform you that there have been a few more children that have possibly contracted Chicken Pox at AWS. It is likely there may be more cases that will pop up in the next week or so as we near the end of the initial incubation period from the first child that was diagnosed earlier in the month, so please be on the look out for symptoms in your children.

Chickenpox is a mild and common childhood illness caused by a virus called varicella zoster. It is most common in children under the age of 10 and is contagious. The incubation period is approximately 21 days and the person is contagious from 1 to 2 days before the spots appear until the spots have crusted over (usually 5-6 days after the spots appear).

Groups of people that are most at risk of serious problems if they catch chickenpox are newborn babies, pregnant women and those with a weakened immune system; therefore it is important, if your child has chicken pox, to keep them at home while they are contagious.

Our school policy states that if a child is suspected of having chickenpox, parents will be contacted immediately and asked to collect their child from school. All children should remain at home until all chickenpox spots have crusted over to avoid further spread of the illness. Should any child return to school before this time, parents will be contacted and asked to collect them and take them back home.

We appreciate your understanding on this and if you have any questions, please do not hesitate to get in contact with us.

Kind Regards,
The Faculty and staff of AWS

Read a story about the school’s outbreak from CNN here:

It is not known if the Asheville Waldorf School made it clear to parents of current or incoming students that their school had a large number of children who were unvaccinated.  If they did not, and a child with a true medical exemption (say, a child with leukemia still getting chemotherapy) was infected by a healthy student whose parents claimed a so-called “religious exemption,” would the former child’s parents blame the school (and the other student) for hospital costs and medical complications?  Or, in this litigious world, what about a child who was infected by a classmate and whose mother simply missed a week of work from her very well-paying job in the busiest season of the year?

When a school (or preschool, or daycare center) has a stated policy that requires vaccination yet allows “exemptions” on the basis of nothing but a note from a parent, that institution is asking for epidemics like this to occur.  Since universal vaccination is known to be safe and to keep students healthy, how does a school justify not enforcing state policy???  If there is a complication from such a preventable illness, the school might easily be considered at fault by failing to adhere to infection control guidelines.  For a parent to claim “religious freedom” when there is NO religion that prohibits vaccination is deceptive.  For a school to accept such a flimsy excuse is neglecting its obligation to its own students. 

Although chickenpox is normally a mild disease (characterized by fever, lethargy, and blisters on the skin), it often lasts a week or longer, causing parents to miss work.  More importantly, chickenpox in very young infants can be much more serious, and potentially fatal to the very young and the very old.  About 1% of patients with chickenpox are hospitalized with a complication, and about 1% of those hospitalized (or 1 in 10,000 patients) die of the disease or its complications.  

So what is a state to do?

In California, a law was passed in 2015 that prohibited all personal and religious exemptions, while maintaining the exemption for true medical conditions.  The result was a sustained increase in vaccinated children throughout the state.  Why is every other state not following its lead????

What are your thoughts??  Please comment.

Vaccines recommended for travel – holiday edition

For those traveling out of the U.S. for the winter holidays, many children should be getting travel vaccinations.  Although most vaccinations recommended for travel for children are already given routinely, several are suggested to be given at an earlier age prior to upcoming international travel.  High on this list are those for Hepatitis A and measles.  Although vaccines both are normally given at age 1 year, both are currently recommended by the CDC for infants to be given earlier – between 6 and 11 months old – for ANY international travel (for measles) and to most of the world, with the exceptions of Canada, western Europe New Zealand, Australia and Japan (for Hepatitis A).  Luckily, these are vaccines that your pediatrician’s office already has in stock!  See for complete information.

Hepatitis A:

Until recently, Hepatitis A vaccine was already given starting at age 12 months to infants in the U.S.  If travel to a high-risk area was anticipated, the only option before 1 year of age was to give IgG, also called “gamma globulin.”  However, since this is a human blood product, this is not ideal at any age.  Now, Hep A vaccine can be given at the age of 6 months or older.  The CDC press release states “People 1 year of age and older who are traveling to or working in countries where they would have a high or intermediate risk of hepatitis A virus, should strongly consider the Hepatitis A vaccine.  These areas include all parts of the world except Canada, western Europe and Scandinavia, Japan, New Zealand, and Australia.”  The following quote is taken from the CDC website: 

“Infants aged 6–11 months. HepA vaccine should be administered to infants aged 6–11 months traveling outside the United States when protection against HAV is recommended.”


Similarly, measles vaccine is routinely given starting at 12 months in the U.S., but since measles is endemic (common and widespread) in many countries, for several years it has been recommended that infants from 6-11 months receive a measles vaccine (that is, MMR) prior to travel.  Again, the CDC’s language:

“People 6 months of age and older who will be traveling internationally should be protected against measles. Before any international travel—

Infants 6 through 11 months of age should receive one dose of MMR vaccine.

**It is important to add that these doses of MMR and Hep A vaccines do not “count” towards the 2 doses of each that they will still need to get later on according to the standard vaccination schedule.

There are also numerous other vaccines and medications recommended for international travel.  For example, for travel to many parts of the world, it is recommended to get typhoid and yellow fever vaccines.  Likewise, for many destinations it is highly recommended to use medication to prevent malaria, which can be done safely and effectively for infants as small as 11 lbs.  See for more information.

Influenza update: October edition

OK, everyone, it’s officially flu season – we are seeing influenza in emergency departments and hopefully all doctors are in full swing of giving flu vaccinations to any and all who want them.  My office in particular is giving both injectable (“killed”) flu vaccine and the nasal spray (“live”) flu vaccine.  Between the 12 of us docs there’s a pretty even split between what we all prefer, although patients/parents make the ultimate choice if either one is appropriate for the patient’s age and medical condition.  We continue to get the question “Well, I didn’t give [my child] the vaccine last year and he/she was fine – why should we give it this year?”  The simple answer is, whether or not one will get the flu in a particular season, and how severe a case one might get, is impossible to predict.  But pretty much all public health authorities agree that gambling on staying healthy without vaccination is a bad bet.  Last year we had one of the worst flu seasons on record, with around 80,000 deaths in the U.S., mostly among those who were not vaccinated.  The downside to getting a vaccine (the inconvenience of showing up and the pain IF you get the shot and not the nasal spray) pales in comparison to the downside of getting a bad case of the flu.  Period.

Also, see this NPR story on someone who gambled and lost:

Australia set to ‘eliminate’ cervical cancer by 2028

Australia has just announced that it is on track to banish cervical cancer (caused by human papilloma virus infection) in the next 10 years!  As you likely know, this is the virus that causes most cases of cervical cancer, genital warts, anal cancers and many head and neck cancers.  You may also know that although we have had the same vaccines and screening tests for a while, in the U.S. our vaccination rates are dismally low compared with some other countries.  Not only will Australia save many lives and prevent many surgeries with this milestone, it will also save tremendous amounts of money on having to care for these illnesses.  Here’s the link:



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