New Year, New Vaccines

Millions of Americans are forging ahead with their annual travel plans for New Year’s, despite pleas from public health experts to stay home and avoid fueling the raging coronavirus pandemic which has killed more than 330,000 nationwide. As Americans celebrated Christmas, over 225,000 new Covid-19 cases were recorded, 117,344 people were hospitalized, and 1,646 Americans lost their lives. Experts warn that the coming weeks may get worse as Dr. Fauci stated the following: “We very well might see a post-seasonal — in the sense of Christmas, New Year’s — surge, and as I’ve described it, as a surge upon a surge.”  In recent days, states such as Hawaii, Georgia, and Louisiana have already reintroduced restrictions as residents brace for another lockdown.  Amidst this seemingly dire situation, Americans eagerly await the only true way out of this crisis: a vaccine.   

In early December, the FDA granted emergency use authorization to Pfizer and its partner BioNTech for their mRNA vaccine for COVID-19.  When receiving an mRNA vaccine, an individual acquires the genetic material responsible for the virus rather than a weakened or dead version of the virus.  Cells in the body subsequently translate the genetic material into viral proteins.  Although mRNA vaccines are relatively new, they are potent and easier to produce.  Unlike the SARS-COV-2 found in nature, the mRNA vaccine only codes for a crucial component of the viral protein.  After producing the harmless protein, the cells degrade the mRNA strand using its enzymes.  Thus, an individual’s immune system is exposed to the virus and produces specific antibodies, readying the immune system to fight off future infections.Following the first dose, Pfizer’s vaccine was shown to be 95% effective.  The Phase 3 clinical trial of their vaccine began on July 27 with 43,661 participants as of November 18th, and 41,135 of the aforementioned participants received a second dose of the vaccine as of November 13, 2020.  Their vaccine accounts for individuals of diverse backgrounds with respect to age, race, and ethnicity.   Accounting for different racial and ethnic backgrounds is especially important in order to maintain consistency in distribution while supporting the vaccine’s credibility amongst different groups. 

As depicted in Figure 1, all minority groups have higher cases, hospitalization, and death rates compared to white, non-Hispanic people. American Indian or Alaska Natives have the highest hospitalization and case rates, while black or African Americans have the highest death rate. Keeping these numbers in mind, vaccine trials should actively include different groups, and the vaccine itself should be equitably distributed.

Unfortunately, Pfizer’s vaccine is not without its challenges.  Experts voiced concerns about the efficiency of Pfizer’s storage and shipping capabilities.  Pfizer’s vaccine needs to be stored at -70 degrees Celsius for up to 10 days in order to preserve the vaccine.  Such a low temperature presents logistical challenges for trucks, planes, and hospitals without such cold storage capabilities.  Coupled with the already existing shipping and distribution issues resulting from the pandemic, the doses and their freezing technologies may face a delay, presenting an additional challenge.  Since Pfizer’s vaccine requires two doses, it is imperative that the doses be delivered in a timely manner and do not go to waste.  Nevertheless, Pfizer is taking measures to ensure that the vaccines are effectively supplied.  Pfizer continues to be in conversation with local, state, and federal officials to coordinate distribution across different points of vaccination, including hospitals and community locations.  Through their efforts, Pfizer and the government are striving to make the vaccine readily available to all people. Additionally, they will use GPS-enabled thermal sensors with a control tower that will monitor the temperature and location of each vaccine shipment.  These devices will allow the company to monitor changes and act accordingly.  According to Pfizer, after the shipment arrives at its final destination, the vaccine can be placed in select storage: ultra-low temperature freezers, refrigeration units commonly available in hospitals, and the Pfizer thermal shippers themselves.  By diversifying their transportation and storage methods, Pfizer presents diverse solutions to overcome their logistical challenges.  Ultimately, Pfizer celebrated its success because on Monday, December 14th, the first of the approved vaccines were administered in Queens.

Meanwhile, on December 18th, a week after approving Pfizer’s vaccine, the FDA approved Moderna’s vaccine.  Moderna’s own COVID-19 vaccines have also shown promising results without facing the same storage and distribution challenges as Pfizer.  At 94.5% efficiency, Moderna’s vaccine is extremely promising.  Unlike Pfizer’s vaccine, Moderna’s vaccine, which is also mRNA based, only needs to be stored at -20 degrees Celsius.  While the temperature is still low and requires cooling units, its storage allows for more flexibility than Pfizer’s.  According to General Gustavo Perna, the COO of Operation Warp Speed, Moderna’s vaccine will be available in more locations than Pfizer’s because it does not require the same advanced freezing technologies.  Last week, over 5.9 million doses of Moderna’s vaccine arrived at 3,400 locations.  

Just yesterday, the United Kingdom approved AstraZeneca’s vaccine and is expected to begin rolling vaccinations out in January.  However, AstraZeneca is facing controversy over their lack of transparency.  In their study, some participants only received a partial dose of the vaccine, resulting in some irregularities in their analyses and review.  Among other irregularities, it was found that AstraZeneca’s vaccine was more effective at lower doses than at higher ones.  After being subject to heavy scrutiny, AstraZeneca will need to reevaluate their data.  With this said, they report that their vaccine has approximately 70% efficiency, though this number is subject to change.  Unlike its competing mRNA vaccine counterpart, AstraZeneca’s vaccine is a chimpanzee adenovirus vectored vaccine.  Their vaccine contains a genetically altered version of a different virus which now contains a gene for a coronavirus protein.  If successfully approved, AstraZeneca’s vaccine would be inexpensive, costing only a few dollars per dose, and can be stored in normal refrigerators for months, unlike its mRNA vaccine counterparts.  In the future, AstraZeneca plans to conduct an additional global trial to compare the two dosing administrations to confirm whether their initial observations were a fluke or a new, promising discovery.  With Pfizer’s vaccine already approved in the EU, AstraZeneca is on track to become the second company in Europe to achieve authorization. With vaccines on the horizon, Americans can hope for a better year.  Over 11 million doses have been distributed and over 2 million Americans have been vaccinated. Still, until the vaccines are effective and widely available, Americans must remain cautious.  Americans should socially distance, limit their gatherings, wash their hands, and wear masks as these are the only proven methods for stopping the spread of COVID-19.  While life will not be as it once was without a vaccine, we, as a community, must always strive to keep ourselves and others safe and secure.  We must all do our part and face the virus, unified together.