Taber Ball, Class of 2024
November and December have brought a flurry of news regarding experimental vaccines to prevent COVID-19. Moderna led the charge, announcing the promising results from the first interim analysis of their Phase 3 COVE study on November 16th. Their mRNA vaccine uses novel technology to prevent the coronavirus at an efficacy rate of 94.5% (Moderna Announcement on Efficacy November 16). Two days later, Pfizer and BioNTech announced that their similar mRNA-based vaccine met all of the study’s primary endpoints and boasts an efficacy rate of 95% (Pfizer Announcement on Efficacy November 18). Both Moderna and Pfizer have applied for Emergency Use Authorization from the FDA. On December 2nd, Pfizer was approved for use in the UK as early as the following week (Pfizer Approved for use in the UK ). On November 23rd, AstraZeneca and the University of Oxford announced that a preliminary analysis proved their vaccine to be effective (AstraZeneca Announcement on Efficacy November 23).
Pfizer and Moderna are coordinating with the Trump Administration’s Operation Warp Speed, the public-private partnership initiated to facilitate the accelerated production and distribution of COVID-19 vaccines, treatments, and therapies. The first doses of the Pfizer vaccine could be available as early as January 2021 assuming federal regulators authorize the vaccine on the Emergency Use Authorization (Operation Warp Speed Distribution Plan). California’s distribution of the vaccine will be guided by the California Department of Public Health’s Allocation Guidelines for the COVID-19 Vaccine which recommends that the vaccine first be administered to health care workers, employees at long-term care facilities, and residents at long-term care facilities. Based on the distribution allocation, the vaccine will likely not become available to the general public until Spring 2021 (CA Statement on Vaccine).
The Pfizer and Moderna vaccines are the first to make use of mRNA technology. According to medical literature, mRNA vaccines combine beneficial immunological characteristics with an excellent safety profile and unparalleled versatility. They also are capable of inducing a balanced and complete immune response. Furthermore, mRNA vaccines are inherently safe, as mRNA is a minimal and only transient carrier of information that does not interact with the genome. Any protein can be expressed from mRNA without the need to adjust the production process, meaning these vaccines have incredible implications for the future of medicine (PubMed Publication about mRNA Vaccines).
The AstraZeneca vaccine varies from the Pfizer and Moderna vaccines as it makes use of a viral vector based on a weakened version of a common cold virus to deliver the genetic material of the SARS-CoV2 virus spike protein. The idea is that after vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV2 virus if it later infects the body. The AstraZeneca vaccine, however, only shows an average efficacy rate of 70% (AstraZeneca Announcement on Efficacy November 23).
None of the three vaccines reported any serious safety incidents or concerns from their clinical trials. Pfizer and Moderna reported that their vaccines were generally well tolerated. Moderna shared that the majority of adverse reactions were mild or moderate in severity. Severe events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia or muscle pain (8.9%), arthralgia or joint pain (5.2%), headache (4.5%), pain (4.1%) and erythema or redness at the injection site (2.0%). Each of these adverse effects were short-lived (Moderna Announcement on Efficacy November 16). Similarly, Pfizer reported that most solicited adverse events were short-lived and those that occurred with greater than or equal to 2% frequency included fatigue (3.8%) and headache (2.0%) (Pfizer Announcement on Efficacy November 18). AstraZeneca reported that its vaccine was well tolerated, but they did not share the frequency of the adverse events related to their vaccine (AstraZeneca Announcement on Efficacy November 23).
The challenge that these companies face is the need for maintained temperature conditions so that the doses do not denature. Pfizer has developed specially designed thermal shippers to maintain temperature conditions of -94ºF. These thermal shippers can be used as storage for up to fifteen days by refilling them with dry ice (Pfizer Announcement on Efficacy November 18). Meanwhile, Moderna is in the process of ensuring that handling, storage, and distribution of their vaccine can be done using existing infrastructure. The Moderna and AstraZeneca vaccines are expected to remain stable at standard refrigerator temperatures of 35.6º to 46.4ºF and shipping and long term storage conditions should be maintained at standard freezer temperatures of -4ºF. This will make for convenient storage and easy distribution of these vaccines (Moderna Vaccine Storage/Transport details, AstraZeneca Announcement on Efficacy November 23).
Now in the ninth month of the COVID-19 pandemic, Americans are faced with more government lock-downs and quarantines in an effort to reduce the spread of the virus. Furthermore, the US public is divided over whether to get the COVID-19 vaccine. A September study by the Pew Research Center showed that only half of American adults say they would definitely or probably get a vaccine to prevent COVID-19 if it were available. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Those who are opposed to getting vaccinated cite their reasoning as concern regarding side effects and vaccine efficacy. Most Americans are concerned that the vaccine approval process will proceed too fast and fail to establish that the vaccine is safe and effective (Pew Research on How Americans feel about the Vaccine). Hopefully, the announcements and data shared by Moderna, Pfizer, and AstraZeneca will help to ease the minds of Americans and encourage them to reconsider their decision to get vaccinated.
References:
Moderna Announcement on Efficacy November 16
Pfizer Announcement on Efficacy November 18
AstraZeneca Announcement on Efficacy November 23
PubMed Publication about mRNA Vaccines
Moderna Vaccine Storage/Transport details
Pew Research on How Americans feel about the Vaccine
Pfizer Approved for use in UK
Pfizer Files for EUA on November 20
Moderna Files for EUA on November 30
CA Statement on Vaccine
California Department of Public Health’s Allocation Guidelines for the COVID-19 Vaccine
Moderna Vaccine Storage/Transport details
Pew Research on How Americans feel about the Vaccine
Pfizer Working with US on Distribution Plan
Operation Warp Speed Distribution Plan
Pfizer Approved for use in UK
Pfizer and Moderna are coordinating with the Trump Administration’s Operation Warp Speed, the public-private partnership initiated to facilitate the accelerated production and distribution of COVID-19 vaccines, treatments, and therapies. The first doses of the Pfizer vaccine could be available as early as January 2021 assuming federal regulators authorize the vaccine on the Emergency Use Authorization (Operation Warp Speed Distribution Plan). California’s distribution of the vaccine will be guided by the California Department of Public Health’s Allocation Guidelines for the COVID-19 Vaccine which recommends that the vaccine first be administered to health care workers, employees at long-term care facilities, and residents at long-term care facilities. Based on the distribution allocation, the vaccine will likely not become available to the general public until Spring 2021 (CA Statement on Vaccine).
The Pfizer and Moderna vaccines are the first to make use of mRNA technology. According to medical literature, mRNA vaccines combine beneficial immunological characteristics with an excellent safety profile and unparalleled versatility. They also are capable of inducing a balanced and complete immune response. Furthermore, mRNA vaccines are inherently safe, as mRNA is a minimal and only transient carrier of information that does not interact with the genome. Any protein can be expressed from mRNA without the need to adjust the production process, meaning these vaccines have incredible implications for the future of medicine (PubMed Publication about mRNA Vaccines).
The AstraZeneca vaccine varies from the Pfizer and Moderna vaccines as it makes use of a viral vector based on a weakened version of a common cold virus to deliver the genetic material of the SARS-CoV2 virus spike protein. The idea is that after vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV2 virus if it later infects the body. The AstraZeneca vaccine, however, only shows an average efficacy rate of 70% (AstraZeneca Announcement on Efficacy November 23).
None of the three vaccines reported any serious safety incidents or concerns from their clinical trials. Pfizer and Moderna reported that their vaccines were generally well tolerated. Moderna shared that the majority of adverse reactions were mild or moderate in severity. Severe events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia or muscle pain (8.9%), arthralgia or joint pain (5.2%), headache (4.5%), pain (4.1%) and erythema or redness at the injection site (2.0%). Each of these adverse effects were short-lived (Moderna Announcement on Efficacy November 16). Similarly, Pfizer reported that most solicited adverse events were short-lived and those that occurred with greater than or equal to 2% frequency included fatigue (3.8%) and headache (2.0%) (Pfizer Announcement on Efficacy November 18). AstraZeneca reported that its vaccine was well tolerated, but they did not share the frequency of the adverse events related to their vaccine (AstraZeneca Announcement on Efficacy November 23).
The challenge that these companies face is the need for maintained temperature conditions so that the doses do not denature. Pfizer has developed specially designed thermal shippers to maintain temperature conditions of -94ºF. These thermal shippers can be used as storage for up to fifteen days by refilling them with dry ice (Pfizer Announcement on Efficacy November 18). Meanwhile, Moderna is in the process of ensuring that handling, storage, and distribution of their vaccine can be done using existing infrastructure. The Moderna and AstraZeneca vaccines are expected to remain stable at standard refrigerator temperatures of 35.6º to 46.4ºF and shipping and long term storage conditions should be maintained at standard freezer temperatures of -4ºF. This will make for convenient storage and easy distribution of these vaccines (Moderna Vaccine Storage/Transport details, AstraZeneca Announcement on Efficacy November 23).
Now in the ninth month of the COVID-19 pandemic, Americans are faced with more government lock-downs and quarantines in an effort to reduce the spread of the virus. Furthermore, the US public is divided over whether to get the COVID-19 vaccine. A September study by the Pew Research Center showed that only half of American adults say they would definitely or probably get a vaccine to prevent COVID-19 if it were available. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Those who are opposed to getting vaccinated cite their reasoning as concern regarding side effects and vaccine efficacy. Most Americans are concerned that the vaccine approval process will proceed too fast and fail to establish that the vaccine is safe and effective (Pew Research on How Americans feel about the Vaccine). Hopefully, the announcements and data shared by Moderna, Pfizer, and AstraZeneca will help to ease the minds of Americans and encourage them to reconsider their decision to get vaccinated.
References:
Moderna Announcement on Efficacy November 16
Pfizer Announcement on Efficacy November 18
AstraZeneca Announcement on Efficacy November 23
PubMed Publication about mRNA Vaccines
Moderna Vaccine Storage/Transport details
Pew Research on How Americans feel about the Vaccine
Pfizer Approved for use in UK
Pfizer Files for EUA on November 20
Moderna Files for EUA on November 30
CA Statement on Vaccine
California Department of Public Health’s Allocation Guidelines for the COVID-19 Vaccine
Moderna Vaccine Storage/Transport details
Pew Research on How Americans feel about the Vaccine
Pfizer Working with US on Distribution Plan
Operation Warp Speed Distribution Plan
Pfizer Approved for use in UK
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