Covid-19 Vaccine Update

There is a COVID-19 vaccine on the horizon. The U.S. Food and Drug management released a fifty-three page report summarizing data from Pfizer and BioNTech's candidate vaccine trial for SARS-CoV-2 on December 10, 2020 (The full report is in a link below.) Federal regulators have given emergency approval to use vaccines developed by Pfizer-BioNTech and Moderna. Both vaccines require people to receive two doses spaced weeks apart.

The mRNA-1273* vaccine candidate was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID). The records state earlier findings that it is probable that the vaccine will prevent 95% of people from becoming sick with COVID-19. It was cited that the first vaccine dose seemed to be 52% defensive, according to the FDA’s report. However, due to the reality that everyone received a second dose 3 weeks after the primary, and the final analyses have a limited length to follow up, it is not possible to assess sustained safety over a period longer than a couple weeks. We do know, however, that the vaccine has been verified to be effective, according to the FDA's standards, amongst 22,000 volunteers who received it. Many trial participants endured side effects after getting their shots, particularly the second dose. The most commonly reported side effect amongst vaccine recipients under age 55 were as follows: 60% had a sore arm, 84.1% had injection site reactions, 62.9% of people were fatigued, 55.1% had a headache, 38.3% had muscle pains, 31.9% were having chills, and others had joint pain and fevers.

Right now, what we recognize is that the Pfizer, BioNTech and Moderna candidate vaccines will probably prevent COVID-19 symptoms and extreme illness. It is not clear whether or not a vaccinated person can also contract COVID-19 and give it directly to someone else, even without becoming unwell, after getting the vaccine. An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigatory COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its analysis with the trial. This review suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The assessment was from 95 instances of symptomatic COVID-19 volunteers. The DSMB reported that the vaccine's success rate was 94.5%. The Phase 3 vaccine efficacy trial, referred to as COVE, ended up starting out beneath OWS, a multi-employer collaboration led with the aid of HHS and the branch of protection that targets to enhance up the development, production and distribution of clinical countermeasures for Covid-19. CDC noted how vaccine distribution will likely retain in phases:

• Phase 1 – There will be an initial limited supply of vaccine doses that will be prioritized for certain groups and distribution more tightly controlled with limited number of providers administering the vaccine.

• Phase 2 – Supply would increase and access expand to include a broader set of the population, with more providers involved, and;

• Phase 3 – There would likely be sufficient supply to meet demand and distribution would be integrated into routine vaccination programs.

Where Are States in Their Planning to Administer the Vaccine?

A restrained quantity of COVID-19 vaccine doses may start to become available, with greater doses to be had over time. Multiple steps are needed to deliver so many little vials of vaccine to local hospitals and pharmacies, where the medication can be injected into a person’s arm. Moderna’s vaccine has to be shipped at –4 degrees Fahrenheit, and it can then be stored at that temperature for six months. Once thawed and kept in a refrigerator between 36 to 46 degrees, it is good for up to 30 days. Pfizer’s vaccine must be kept at –94 degrees F, a much greater challenge. Once transferred to a refrigerator, it has to be administered within five days. In the U.S., Moderna will manufacture its vaccine in New Hampshire, Pennsylvania and Indiana. It will ship vials to McKesson Corporation’s distribution center in Irving, Texas, the hub of the federal government’s Operation Warp Speed vaccination initiative. Moderna also plans to manufacture the intervention in Switzerland and Spain. Other places from Stockholm to Athens, and Lisbon to Warsaw, European Union governments are getting ready to receive a COVID-19 vaccine possibly later this week. Pfizer will make its U.S. vaccine in Kalamazoo, Mich. It is not distributed through Operation Warp Speed, so it will ship large thermal boxes of filled vials, jammed with dry ice, via companies such as UPS and FedEx to locations around the country. Pfizer also has a production site in Belgium. On November 16, the company launched a pilot program to test its delivery plan to four states: Rhode Island, Tennessee, Texas and New Mexico. Based on the data of their plans, other states are in varying levels of getting ready to dispense a COVID-19 vaccine. All have mounted an undertaking force or are making committees to influence these efforts, which include representatives from different sectors. However, a few have been making plans for numerous months, while other states have only recently begun to created detailed plans.

Some states have already started the procedure of signing up providers to manage COVID-19 vaccines and construct existing immunization registries, while others are still just growing plans to do the same. However, these preliminary plans are to be considered drafts, at best, and will be updated as more statements from the federal government about a vaccine itself emerge.. Each state must decide precisely who will be first in line to receive the probably constrained variety of available vaccine doses. Regarding their plans, almost each country reviews that they are depending closely on steering from federal authorities to outline priority populations, drawing on pointers from the countrywide Academies of medication and anticipating additional steerage from the CDC’s Advisory Committee on Immunization Practices. Each nation's plans follow large classes as being populations for section 1 efforts: health care employees, crucial employees, and those at high hazard (older people and those already with health problems). Maximum plans recognize and note, according to the CDC, that there will likely no longer be sufficient vaccines for all people diagnosed in those segment 1 precedence organizations. Other people, like President-elect Joe Biden and incoming first lady Jill Biden, will both publicly receive their first doses of a Covid-19 vaccine in Delaware on December 28, amongst other politicians.

In all, there is at least a partially effective vaccination and distribution on the horizon for the world, with the U.S. working hard to make sure that there is something being put forth to help us all get vaccinated and escape this time of quarantine and isolation. There are many new updates regarding what’s happening with the vaccine, as of this issue's publication, so make sure to keep checking up on new announcements.

Updates: As of December 26, more than 1.9 million people in the U.S. have received a COVID-19 vaccine. The first day of mass Moderna Covid-19 vaccinations was at the Kentucky State Fair and Exposition Center on January 4 in Louisville, Kentucky. Johnson & Johnson tells CNN its Janssen COVID-19 vaccine trial is still on track and the company should have enough data “toward the end of January” to determine if the vaccine is safe and whether or not it provides protection against COVID-19, as of January fourth.

*COVID-19 (Coronavirus)

Full pages of FDA vaccine report- https://www.fda.gov/media/144245/download

Sources: https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine#:~:text=This%20interim%20review%20of%20the,vaccine%20efficacy%20rate%20of%2094.5%25.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html

https://www.scientificamerican.com/article/the-covid-cold-chain-how-a-vaccine-will-get-to-you/