The Covid-19 vaccine under development by Pfizer Inc and BioNTech is reportedly showing very promising results in the initial trials. On Monday, the company said that it could be dubbed as a significant victory in the war against the virus that has killed over a million people and crippled the world economy.
The experts are welcoming the first successful interim data from a large-scale clinical test. However, the vaccine’s mass distribution will be a significant issue due to several roadblocks, including storage requirements and regulatory approvals.
Pfizer expecting regulatory approval by December
Pfizer and German partner BioNTech said they had not found any serious safety concerns yet. They expect to get emergency use authorization this month in the US, which will raise a chance of regulatory approval in December. In case the company receives the required permissions, they can roll out 50 million doses this year, which will protect 25 million people. In 2021, the company expects to produce 1.3 billion doses.
Pfizer Chief Executive Albert Bourla said data milestone comes with “infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.” The experts are waiting to check the full trial data, but the initial results are encouraging. Peter Horby, professor of emerging infectious diseases at the University of Oxford, said, “This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general.” U.S. infectious diseases expert Dr. Anthony Fauci told CNN that it is extraordinary that the vaccine is more than 90% effective.
The company is seeking US emergency use authorization for people between the 16 to 85 age group. A follow-up safety data of two months is required for the said permission as it is necessary to assure no side effects crop up. The said data should be available by the third week of November. According to the U.S. Health and Human Services Secretary Alex Azar may take several weeks for the regulators to process data before approving the vaccine.
The vaccine may not be available in the pharmacy next door
One of the main issues that will make the distribution difficult is that the vaccine requires minus 70 degrees (-94 F) or below. Amesh Adalja, the senior scholar at Johns Hopkins Center for Health Security, said, “The cold chain is going to be one of the most challenging aspects of the delivery of this vaccination.” Even in the big cities, the hospitals do not have such storage facilities where storing vaccines at ultra-low temperature is possible.
Even one of the US’s best hospitals, the Mayo Clinic in Rochester, Minnesota, said they could not store the vaccine. Dr. Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic, said, “We’re talking about a vaccine that needs storage at minus 70 or 80. That’s a tremendous logistical issue not only in the U.S. but outside the Western world.”
Pfizer spokeswoman Kim Bencker said they are working with the US government and state officials to ensure the smooth distribution of the vaccine worldwide from its distribution centres in the US, Germany, and Belgium.
The vaccine will spoil in five days of standard refrigeration
In general, the refrigeration system at most of the storage facilities across the globe store medicines at 2-5 degrees above the freezing point. In such a situation, the vaccine will be viable only for five days. The company is finding ways to store it for up to two weeks. However, if the vaccine is stored under minus 70 degrees, it can remain usable for up to six months.
Other vaccines do not need such low-temperature storage
The vaccine of Moderna Inc works on similar technology as Pfizer, but it does not need such low-temperature storage. Vaccines by Johnson & Johnson and Novavax Inc can be stored at 2-8 degrees, which is in the normal range of storage facilities’ refrigeration units.
While the hospitals are working on upgrading their storage facilities in the US, it will be far more challenging to distribute the vaccination for the developing countries and rural areas.