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  2020-09-14

  Pfizer and BioNTech announce plan to expand Covid-19 vaccine trial

  Pfizer and BioNTech are moving to enlarge the Phase 3 trial of their Covid-19 vaccine by 50%, which could allow the companies to collect more safety and efficacy data and to increase the diversity of the study’s participants. The companies said in a press release that they would increase the size of the study to 44,000 participants, up from an initial recruitment goal of 30,000 individuals. The U.S. Food and Drug Administration will have to approve the change before it goes into effect. “The companies continue to expect that a conclusive readout on efficacy is likely by the end of October,” the press release said. The Pfizer and BioNTech study is likely to be among the first in the U.S. to report efficacy data from a Phase 3 trial. Related: AstraZeneca resumes Covid-19 vaccine trials in the U.K. Expanding the trial will likely make it easier for the company to demonstrate whether the vaccine is effective against SARS-CoV-2, the virus that causes Covid-19. The companies also said that the change will allow the study to include a more diverse population. The companies said the study will now include adolescents as young as 16, people with stable HIV, and those with hepatitis C or hepatitis B. The companies said that the trial is expected to reach its initial target of 30,000 patients next week. Moderna, which started its trial on the same day as Pfizer, said on Sept. 4 that it is working to increase the diversity of trial participants in its study, “even if those efforts impact the speed of enrollment.” Related: Covid-19 Drugs and Vaccines Tracker The Pfizer/BioNTech study could finish sooner than Moderna’s, even though the two began on the same day, for other reasons, as well. Both vaccines require a second shot; Pfizer’s is given after three weeks, while Moderna’s is given after four. The Pfizer trial also starts to count cases of Covid-19 sooner after participants receive their shots than the Moderna study. But the Pfizer/BioNTech vaccine could also prove to be one of the most difficult of the experimental vaccines to distribute, should they prove effective. The vaccine must be kept at a temperature of -70 degrees Celsius. There has been political pressure to move a vaccine quickly, with President Trump saying that one could be available before election day. Last week, several drugmakers, including Pfizer, issued a pledge not to move a vaccine forward sooner than was justified by the results of their clinical trials.
• 2021-01-24

  Two Main Vaccines and Where to Find Them

  1. Pfizer, mRNA vaccine – manufactured by Pfizer and BioNTech, offered across the U.S. in every state 2. Moderna, mRNA vaccine – manufactured by ModernaTX, offered across the U.S. in every state Bibliography: CDC. 2020. “Coronavirus Disease 2019 (COVID-19).” Centers for Disease Control and Prevention. February 11, 2020. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fhow-they-work.html. Calgary, Open. n.d. “COVID-19 Vaccine Distribution Allocations by Jurisdiction - Pfizer | Data | Centers for Disease Control and Prevention.” Data.cdc.gov. Accessed January 25, 2021. https://data.cdc.gov/Vaccinations/COVID-19-Vaccine-Distribution-Allocations-by-Juris/saz5-9hgg.
• 2021-01-24

  Differences and Similarities Between the COVID-19 Vaccines

  There are 3 types of vaccines that are or will be available in the U.S. 1. mRNA: uses part of the COVID-19 virus to create proteins in our bodies that our immune system can recognize and remember in order to fight the virus 2. Protein subunit: has pieces of the proteins that the COVID-19 vaccine uses (not the actual virus) that the body will recognize in the future that do not belong in the body 3. Vector: injection of a weakened but live virus that has the genetic material that causes COVID-19 (a vector virus) that will cause the body to make the proteins that cause COVID-19 and force the immune system to remember that protein and fight it in the future The two being offered across the U.S. right now are both mRNA vaccines that require 2 shots 21 days apart Both vaccines are tested with a 95% effectivity, but that effectivity is only proven to be true after both doses are administered and there is not substantial long-term effect research yet Bibliography: CDC. 2020. “Coronavirus Disease 2019 (COVID-19).” Centers for Disease Control and Prevention. February 11, 2020. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fhow-they-work.html. “Covid-19 Vaccine Frequently Asked Questions.” 2021. New England Journal of Medicine. 2021. https://www.nejm.org/covid-vaccine/faq?cid=DM108101_&bid=351587577.
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  2020-12-09

  Authorization of the Pfizer-BioNTech Vaccine

  Tweet by Health Canada confirming that the Pfizer-BioNTech vaccine has been approved.
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  2020-12-10

  'We need trust': How a COVID-19 vaccine came so quickly

  News article that details why the vaccine has come so quickly and assuring Canadians that the vaccine has not been rushed.
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  2020-09-28

  "Vaccine Chaos is Looming"

  As the COVID-19 pandemic approaches its one year anniversary, many are hoping that a vaccine will soon become available at their local pharmacy, clinic, or hospital. Unfortunately, this is very unlikely to be the case, as several problems will inhibit vaccine distribution . In an article for The Atlantic Monthly that was published on September 28, 2020, journalist Sarah Zhang provides readers with a comprehensive overview of the logistical problems associated with manufacturing prospective COVID-19 vaccines and distributing them across the United States. Zhang begins the article by noting that while some vaccine candidates have progressed very far in clinical trials, the ones that have are also the most difficult to distribute and deploy in the field. This is due to a variety of reasons, the most prominent being the method used to manufacture the vaccine (i.e mRNA encoding), which is a new, experimental method used to manufacture vaccines rapidly. While this technology has sped up vaccine production, it has come at the expense of convenience, as the prospective vaccines by Pfizer and BioNTech require specialized storage containers to maintain the dosage vials at extremely cold temperatures (-94 Fahrenheit). According to Zhang, this need for extreme refrigeration presents a logistical bottleneck for the distribution and deployment of prospective vaccines. Indeed, according to Zhang, federal, state, and local health departments are making plans for what will most likely be the most ambitious logistical operation in medical history. Logistical problems will be further compounded by issues concerning the lack of preservatives in some vaccines (to speed up production) and the difficulty of delivering dosages to rural areas relative to urban cities. Furthermore, incomplete electronic medical registries in some local areas will make it difficult for health officials to know who exactly needs the vaccine and who should be prioritized when they first become available. In sum, the rapid production methods used by some prospective COVID-19 vaccines will make them more difficult to distribute and deploy in the field. The need to store some in extremely cold temperatures will raise the costs of transportation and make it extremely difficult to deliver dosages to people living in hard to reach areas of the United States. Furthermore, the incomplete electronic medical registries of some local areas will make it more difficult to know if patients are taking the appropriate number of vaccine doses, which are needed to be completely effective. To paraphrase Zhang, these issues will make the first COVID-19 vaccines to be released to be insignificant, as they will not be widely distributed.