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. The views expressed are his own.
As Pfizer is rolling out their COVID vaccines from their units in Michigan and Wisconsin in trucks to the airports, America is losing one life every 30 seconds from this virus. Is this a storm before the calm? The “Manna” that the Israelites were waiting to fall from heaven is now in the skies of America on FedEx and UPS planes and the people are all waiting anxiously for it to land.
The vaccines we were all waiting for are finally here. Today we have 6 approved vaccines for COVID around the globe: 3 from China, 2 from Russia, and one from the USA. There are about 10 vaccines in phase 3 clinical trials which include Moderna from the USA, Astra- Zeneca from the UK, and Bharath Biotech from India.
1.Global Access Facility
COVAX – organization co-led by GAVI, The Coalition for Epidemic Preparedness Innovations (CEPI), and the WHO. Its aim is to accelerate the development and manufacture of COVID 19 vaccines and to guarantee fair and equitable access for every country in the world. India is a signatory to it as other 152 countries, but the USA is not.
2.Operation WARP speed
The private-public partnership initiated by the US Government to facilitate and accelerate the development, manufacturing, and distribution of vaccines within the US. It has funding of 18 billion dollars.
They have invested:
– 1 Billion to the Johnson and Johnson single-dose vaccine. Trials are ongoing at Stanford. There are no temperature control issues.
– 1.2 Billion to Astra Zenica’s 2 dose vaccine. It has an efficacy around 90% and there are no temperature controls.
– 1.53 Billion to the Moderna 2 dose vaccine. Its efficacy is higher than 94% but requires storage at -60. It has an estimated cost of $25-37.
– 1.6 Billion to the Novavax 2 dose vaccine. There are no storage issues. Trials ongoing in the UK.
– Pfizer/BioNtech – There are known storage issues requiring storage at -80. Efficacy is greater than 94%. It will cost $20.
– Bharath Biotech – In Phase 3 Clinical trials in 12 centers. None in Kerala. Cost <Rs100.
The cold chain is an issue for vaccine delivery as we had already seen with oral polio. The International Air Transport Association estimates that in 2019, $34 billion worth of vaccines were wasted because they were subjected to unsafe temperature fluctuations while being shipped. The solution is to work on more thermolabile and easy to administer vaccines.
A Chinese university is doing some trials and Bharath Bio, along with St Louis University in Washington, is in the process of developing a nasal spray vaccine.
It is estimated that US will have a combined supply of about 40 million vaccines from Pfizer and Moderna. Moderna is submitting its EUA on December 29th. Both Moderna and Pfizer use a new approach to unlock the body’s immune defense. The approach uses messenger RNA, or mRNA, to turn a patient’s cells into factories that make one particular coronavirus protein. That protein kicks off an immune response as if there were a real coronavirus infection. It is a new technology and no mRNA vaccines have ever been approved by FDA so far. Though both need subzero storage conditions the, thermo lability of Moderna is much better. Moderna expects that their vaccine can be maintained at -20 C (home freezer temp) for 6 months and in a normal fridge for 30 days or at room temperature for 12 hours. The world has managed these subzero cold chain operations successfully even in Africa for Ebola vaccines. Criteria of selection of candidates for the vaccine will be difficult and hope not to get politicized.
2020 has been a year of incredible scientific achievement. In less than 12 months researchers have characterized a novel virus, sequenced its genes, developed diagnostics, and now vaccines are on in the way. Many people are feeling hopeful for the first time. On November 14th, 5 days after the announcement by Pfizer, 663,772 new cases were recorded. In the last 4 days, we have recorded more than 3000 deaths per day. It is a dangerous time to be complacent. Roll up your sleeves and if you feel a jab you are one of the lucky ones!