New FDA proposal hopes to increase COVID-19 vaccination rates

Johnson&Johnson COVID-19 vaccines at the Javits Convention Center in Manhattan, N.Y., March 3, 2021. Photo by Army Sgt. Sebastian Rothwyn, Army National Guard.

By Lily Benn ’24 

Staff Writer

On Jan. 26, 2023, the Food and Drug Administration of the United States held a meeting to discuss future plans for public health and the administration of COVID-19 vaccines. According to PBS NewsHour, the committee of 21 FDA members voted unanimously to approve the strategy of implementing an annual COVID-19 vaccination, allowing for people of all vaccination statuses to be vaccinated every year. This new system would no longer be dependent on keeping track of the number of primary vaccinations and boosters an individual has received, an article from AP News explains. The online committee meeting included information from an immunologist, Matthew Woodruff, who studies and publishes research on immune responses to COVID-19.

The AP News article goes on to state that while over 80 percent of Americans are vaccinated against COVID-19 with at least one dose, the newest Omicron variant booster approved in August 2022 has only reached about 16 percent of those eligible. As boosters become less popular among Americans, FDA scientists have supported a transition to an annual vaccination model, citing that many Americans have preexisting immunity from COVID-19 due to previous vaccination, infection or both. A news broadcast from WKMG News 6 ClickOrlando by Julie Broughton explains this news, but reports on counterpoints such as “critics” who believe that not enough data exists to sufficiently explain the higher immunity that the FDA has been using to back this new annual vaccination proposal.

This new system would go into effect once approved and backed by the Center for Disease Control, according to an article from PBS NewsHour. This new vaccine would likely be bivalent — or target multiple strains — as COVID-19 evolves. Thus, it would be able to target both the current dominant variant, Omicron, and further strains. Similar to the widely recognized influenza vaccine, it would be reevaluated each year and changed to target new mutations of the spike protein, the article explains.

According to a timeline put out by Mayo Clinic, vaccines targeting various influenza viruses have had a similar history, where pandemics and outbreaks led to widely recognized annual vaccines recommended for the general public. Influenza pandemics occurred in 1918, 1957 and 1958, 1968, the 1970s, and 2009, according to Mayo Clinic. The first introduction of an influenza vaccine recommendation was made in 1960 by the U.S. Public Health Service for people who were at high risk of influenza complications. By 1968, researchers began the development of specific influenza strain vaccines as a new pandemic spread. The article cites that the Advisory Committee on Immunization Practices, a part of the CDC, introduced a recommendation in 2010 that all people aged 6 months and older be vaccinated against influenza annually. By 2019 and 2020, Mayo Clinic reports that annual influenza vaccines have prevented about 7.5 million infections and illnesses. 

According to AP News, the FDA hopes that their new vaccine implementation strategy will increase vaccination rates worldwide, as this strategy would both simplify information and increase health for the general public.

Pharmaceutical Companies Release Coronavirus Vaccine Updates

By Lily Cao ’21

Staff Writer

As COVID-19 levels spike across the globe, many places around the world are heading into another round of lockdowns. Along with this growing second wave come announcements from companies working on possible coronavirus vaccinations. 

On Nov. 9, American pharmaceutical corporation Pfizer Inc. and German biotechnology company BioNTech SE shared that their mRNA-based vaccine candidate, BNT162b2, has shown record-breaking early results with over 90 percent efficacy against COVID-19. This finding from Phase 3 of their clinical trial was the first interim efficacy analysis, which tests the vaccine’s effectiveness under ideal circumstances. The vaccine was given in two doses with results collected seven days after the second dose. Even though it is unclear how strong the elicited immune response is and how long it will last in human bodies, this achievement marks a milestone in the vaccine development process and provides hope for the days ahead.

Pfizer and BioNTech SE launched the Phase 3 clinical trial of their vaccine candidate on July 27. As of Nov. 9, they have enrolled 43,538 participants worldwide. This is also the first American trial to have permission to enroll children as young as age 12. On Nov. 8, 94 trial participants had tested positive for COVID-19, enough to allow for the first analysis on all cases.

According to its Nov. 9 press release, Pfizer plans to present a submission for Emergency Use Authorization to the FDA in the third week of November. The FDA requires the safety and manufacturing data of the vaccine to obtain approval. Meanwhile, in order to ensure the safety and long-term protection conferred by the experimental vaccine, clinical trial participants will be monitored for an additional two years after receiving the second dose.

One of the challenges the companies face is the widespread distribution of the vaccine once it is approved. The vaccine requires that the single-stranded mRNA be kept below -80 C to preserve the structural integrity of the genetic material. Consequently, the transportation of the vaccine requires special storage boxes and precise techniques.

Similar to Pfizer and BioNTech SE, Moderna Inc.’s vaccine candidate also uses mRNA technology, and recent results from its trial indicate an efficacy of over 94 percent. Moderna’s vaccine, however, does not require storage at temperatures of -80 C and can be preserved at about -20 C, giving it a slight advantage. At the same time, there are currently 17 vaccine candidates that have entered the Phase 2 safety trials, and 12 have begun Phase 3 trials for large-scale efficacy tests.

If Pfizer and BioNTech SE’s vaccine candidate is approved, the companies expect to manufacture globally up to 50 million doses in 2020 and up to 1.3 billion doses in 2021.

COVID-19 Vaccine Candidates and How They Work

Graphic by Trinity Kendrick ‘21

By Lily Cao ’22

Staff Writer

Pharmaceutical companies around the world are working to develop vaccines against the novel coronavirus in an effort to alleviate the burdens brought by the global pandemic.

The development of vaccines is a lengthy process. Before a vaccine gets to clinical trials, it must undergo various stages of testing to guarantee its effectiveness. During the preclinical testing stage, the vaccine is given to animals to see whether it elicits an immune response. Once the vaccine has been proven to elicit an immune response in animals, it is administered to a small group of people, then hundreds, then thousands, during Phase 1, 2 and 3 clinical trials, respectively. If the vaccine passes all three trials, regulators then authorize the licensing of the vaccine for public use.

Currently, over 90 COVID-19 vaccines worldwide are in the preclinical testing stage, and 44 are in various phases of clinical trials. However, not every vaccine in development will pass all three trials and arrive at the final approval stage.

The Massachusetts-based biotechnology company Moderna Therapeutics, in collaboration with the National Institutes of Health, has been the frontrunner in coronavirus vaccine development. Its technology is based on injecting viral mRNA into the body. The idea behind this is that the genetic information encoded in the RNA will be translated into protein, subsequently triggering an immune response. Compared to DNA-based vaccines, RNA-based ones are safer, as they pose no risk of altering the person’s natural DNA sequence. RNA vaccines are also less expensive and take less time to produce than traditional vaccines, making them a favorable solution to a rapidly evolving global pandemic like the novel coronavirus. 

If Moderna’s candidate gets approved, it would be the first mRNA-based vaccine to be used on humans. Moderna’s vaccine entered Phase 3 of clinical trials on July 27. It will enroll 30,000 participants from across the U.S. in its final round of testing.

Janssen Pharmaceutica of Johnson and Johnson is investigating the non-replicating viral vector vaccine in which a portion of the coronavirus DNA is introduced into the adenovirus vector, which serves as the vehicle to deliver genetic material into the human body and trigger immune responses. The adenovirus is known to cause the common cold; however, when used in vaccines, the virus is genetically modified so that it will not harm the vaccine recipient. The company launched its Phase 3 trial in collaboration with Operation Warp Speed in September, enrolling 60,000 volunteers worldwide.

Maryland-based biotech company Novavax is known for its efforts in combating infectious diseases using innovative vaccines. Its coronavirus vaccine candidate, NVX-CoV2373, was genetically engineered using its recombinant nanoparticle technology to produce the coronavirus spike protein-derived antigen. The candidate contains Novavax’s proprietary saponin-based Matrix-M adjuvant, which has been shown to augment immune responses. The vaccine works by allowing the antibodies generated to block the binding of the spike protein to receptors on human bodies, thereby stopping the virus from infecting and further replicating in the vaccine recipient. Because Novavax’s vaccine development method is based on traditional vaccine technology, some experts argue that its candidate shows promise, since the world has had experience with this vaccine development method before, unlike the mRNA-based vaccines other companies are developing. Novavax’s Phase 3 trial in the U.K. hopes to enroll up to 10,000 participants ranging from 18 to 84 years old.

However, health care officials warn the public that even if the vaccines get approved soon, there is going to be a lag before their distribution. Moreover, not everybody will want to get vaccinated, and not everybody receiving the vaccine will produce an effective immune response. Therefore, people should still take serious safety precautions like washing their hands, keeping socially distanced and wearing masks.