Dr. JACOB EAPEN-
Dr. Jacob Eapen, a Medical Director at the Alameda Health System(AHS) and a member of the Board of Directors at the Washington Hospital in Fremont, California. He is also the Regional Vice President of the Federation of Kerela Association in North America(FOKANA). The views expressed are his own.
Today as the cities across America is awaiting the planes to land with the precious cargo the setting is similar to The Spy Who Came In From The Cold when a British agent Alec Leamas was being deployed to East Germany as a spy. The anxiety level is high considering the cold chain operation, logistics, storage, distribution and selecting the candidates to be vaccinated. The hype of vaccine transportation in the media is almost like in a James Bond movie. There has never been a public health operation of this magnitude in our history. Now let us look at the cargo…
The Pfizer-BioNTech vaccine is the first approved COVID 19 vaccine approved by FDA for emergency use authorization (EUA) in USA. Five countries around the world; USA, UK, Canada, Mexico
Bahrain and Kuwait have all approved this vaccine under EUA so far. The biggest hurdle of the vaccination is maintaining the cold chain at -80 C which is colder than the Arctic. The cold chain is the logistics of keeping the stability of the vaccine from the manufacturer to the distal clinics. The average time from a factory to point of care is usually four to six months but because of the urgency, this vaccine may be delivered on a compressed timeline which could be less than a month.
It is extremely important when a COVID-19 vaccine is supplied everyone on earth is able to access it. It does no good unless it can reach the people who need them. GPS enabled thermal sensors will track the location and temperature of shipment across their routes. Immunization programs are used to the subzero temperature of other vaccines for chickenpox and Ebola. The other mRNA vaccine candidate Moderna is claiming longer shelf life at refrigerated temperatures. The difference between the two is in the formulation.
The Pfizer thermal shippers in which doses will arrive can be used at temporary storage units by refilling with dry ice every 5 days for 30 days. The vaccine can be stored for 5 days at refrigerated 2-8 C conditions. Once thawed it cannot be refrozen. In ultra-low temperature freezers, it has a shelf life of 6 months.
It is a two-dose schedule with a minimum of 3 weeks apart. The efficacy of the vaccine after the first dose is about 52%and after the second dose it rises to 95%. The vaccine has a high efficacy rate in both men and women, as well as similar rates in white, Blacks, and Latino people. It worked well in obese people, who carry a greater risk of getting sick with Covid. Some vaccines set off a weak immune response in older adults. But the Pfizer vaccine is for people over 65 as much protection from the vaccine as younger adults.
This vaccine is not recommended for:-
- Children less than 16 years (at least for now)
- Breastfeeding, expectant mothers or ones who plan to be pregnant soon.
- Anyone with severe anaphylactic allergic reactions
- And anyone who are allergic to the components in the vaccine – mRNA, lipids (4-hydroxyethyl), polyethylene glycol, potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
The clinical trial sample size was around 44,000 people in the United States, Brazil and Argentina. Half the volunteers got the vaccine and the other half received a placebo. Four people in the vaccinated group developed a form of facial paralysis called Bell’s palsy but the difference between the two groups was not meaningful enough. The other common side effects reported-local reaction (84%), fatigue( 62%), headache(55%), muscle pain(38%), chills(31%), joint pain(23%, and fever(14%).
A vaccine is only as good as it’s accepted. The pundits say we need at least 70 to 80% immunity in the population to obtain herd immunity. Herd immunity is a concept used for protecting a population from a certain virus if a threshold of vaccination is reached. This can be from natural infection or by vaccinations. Herd immunity is achieved by protecting people from a virus, not by exposing them to it. From an article in JAMA looking at the factors associated with the likelihood of accepting COVID-19 vaccination, efficacy was the main factor. Like any other vaccines, there will be an anti-vaccine lobby (antivaxers).
Rumors and stories will be a common phenomenon. Let the whispers of the devil not lead you into temptations to refuse a vaccine. All of us have to be a part in eradicating this virus. Hope a needle with a vaccine will find you before the deadly virus finds you!