Posts tagged with "Moderna"

COVID 19 by Symara Wilson for 360 Magazine, Covid Travel restriction

Coronavirus Mutations × U.S. Travel Restrictions

By Emily Bunn

A breaking news article featured in The New York Times announced that the United States will be imposing a mandatory requirement for negative COVID-19 test results from all incoming, international travelers. The requirement for proof of a negative test in order to fly will begin Tuesday, January 25th.

The CDC has ordered for all travelers to provide proof of a negative test taken no more than 3 days before their travels. Without documentation of a negative test or documentation of recovery supplemented with a letter from a health care provider or public health official, passengers will be prohibited to fly.

The United States is not the only country to be putting in place tighter travel regulations. Due to new mutations of the virus, many countries are adopting stricter border protocol. The New York Times reports:

“Even as the United States moved to impose travel restrictions, citing the danger of the fast-moving variants, a case of the variant spreading in Brazil was identified in Minnesota.”

Variations of the virus in Brazil and South Africa, due to international travel, both pose the threat of COVID-19 mutating. If the virus does mutate, it is potential that the new strain of such will be unreactive to current vaccination efforts.

The New York Times reports that Dr. Anthony S. Fauci, an adviser to President Biden, has commented: “With the world travel that you have, and the degree of transmissibility efficiency, it’s not surprising.” Further, President Biden has broadcasted a ban on travel by all non-citizens into the United States from South Africa, the U.K., Ireland, and 26 other European countries.

An article published today on AP News reported that in attempts to increase vaccination efforts, President Biden announced that his administration is planning to purchase 100 million doses of each of the approved coronavirus vaccines–Pfizer and Moderna. Vaccination deliveries to states will be surged for the next three weeks. The Biden administration has announced that they plan to vaccinate 300 million citizens by the end of summer, as reported by The New York Times.

The President, in a White House briefing on January 26th, commented on importance of increasing vaccination supplies to help Americans:

“And to a nation waiting for action, let me be clearest on this point: Help is on the way.  We can do this if we come together, if we listen to the scientists.”

These efforts come at an especially critical time, as the global number of coronavirus cases has surpassed 100 million, reports The Wall Street Journal. However, that has been recent speculation regarding the accuracy of that number. In New York, Governor Andrew M. Cuomo’s administration has been accused of undercounting the amount of coronavirus deaths that occurred at nursing homes. A report released by Letitia James, the Attorney General of New York, shows that the coronavirus death count appears to have been cut by approximately 50 percent. The report compares the number of facility deaths publicized by the Department of Health–1,229 deaths, versus the number of facility deaths reported the Office of Attorney General–1,914 deaths. This staggering discrepancy between reported deaths has spurred suspicion against Cuomo, and the Office of Attorney General (OAG) is conducting an on-going investigation concerning the cause of these variances.

However, there is still hope. In Los Angeles, Governor Gavin Newsom rescinded the county’s stay-at-home order this past Monday, reports The Los Angeles Times. This new jurisdiction will allow for all counties in California to return to the four-tier, colored-coded system of assessing coronavirus risk. Lifting the imposed stay-at-home order could allow for the reopening of personal care services and outdoor dining. While LA has been particularly hard hit by coronavirus, the city actually has a higher vaccination rate than most other comparable cities in the U.S. The New York Times reports that “83 percent of the doses the city has received have been administered, compared with 74 percent in New York City; 52 percent in Bexar County, which includes San Antonio; and 58 percent of the doses ordered in Maricopa County, which includes Phoenix.”

While the coronavirus situation is still being closely tracked and monitored, hospitalizations and the number of patients in ICUs have been steadily declining. With hospitalizations at their national lowest since December 13th and an increase in vaccination efforts, there is progress to be recognized, despite current setbacks and uncertainties.

Pfizer coronavirus vaccination article illustration by Kaelen Felix for 360 Magazine

Pfizer × BioNTech near historic vaccine

By Althea Champion

Pfizer and BioNTech announced on Monday that their COVID-19 vaccine is more than 90 percent effective. If approved, it could potentially be available to the public by early December, according to Dr. Anthony Fauci.

The results came out of Pfizer’s Phase 3 trial, which involved 40,000 individuals. Of those participating, 94 contracted COVID-19. These results, like much of 2020, are historic. Vaccines have never been developed on such a fast-moving timeline. The last vaccine that was developed in such considerable haste was for mumps, and it took four years.

Pfizer says that they plan to ask the Federal Drug Administration for emergency use by the end of the month. The vaccine will require two doses administered three weeks apart. The company hopes to have enough doses for 25 million people by the end of the year, and 650 million people in 2021.

In the case that the vaccine supply is limited, the C.D.C. will first vaccinate healthcare personnel, essential workers, people who are at high risk for severe COVID-19 illness due to underlying medical conditions, as well as those 65 years and older.

An expedited timeline does not mean drug companies are cutting corners. Fauci, like many of his colleagues in Washington, assures that manufacturers will stick to a process of vaccine development that ensures the safety of patients. The FDA will still make the final call.

“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in Pfizer’s press release. “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.”

However, a few questions remain unanswered.

“Historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions,” writes Arthur Allen in the Opinion section of the NYT. “Not through company press releases.”

According to Allen, it is unclear from the press release how long Pfizer’s vaccine will keep patients protected, if it is safe for high-risk populations like the elderly, or if rare side effects can arise in patients who are vaccinated. He notes that the Novavax and Sanofi Pasteur vaccines may be safer for older patients.

Novavax and Sanofi Pasteur are subunit vaccines, like the hepatitis B vaccine. They deliver only the essential antigens of the virus to the immune system, so it learns how to attack it. Because it is only a part, or a subunit, of the virus, fewer side effects are likely.

Pfizer’s is a nucleic acid vaccine that uses RNA. According to the Washington Post, “this type of vaccine contains a strip of genetic material within a fat bubble” that enters the cell. Once inside, “the RNA generates a protein found on the surface of the virus.” It can then familiarize itself with the virus and learn how to fight it.

Moderna’s vaccine is also an RNA vaccine in Phase 3 trials. Pfizer’s success bodes very well for Moderna, according to a statement Fauci made to CNN.

Furthermore, because the vaccine must be stored in extremely low temperatures—on dry ice at negative 100 degrees Fahrenheit according to the Washington Post—its roll-out becomes complicated. If left out in the sun, or just at room temperature, or even at just below freezing, the mRNA self-destructs and the vaccine becomes useless.

Shortly after Pfizer’s announcement, President-elect Joe Biden addressed the nation, warned of the “dark winter” ahead, and urged Americans, regardless of party affiliation, to wear a mask until the vaccine is available.

The head of the C.D.C. warned this fall, that “for the foreseeable future, a mask remains the most potent weapon against the virus,” he said from the podium. “Today’s news does not change that urgent reality.”

Hiccup in COVID-19 Vaccine Development

By Althea Champion

In a statement from AstraZeneca, reported by STAT News, the biopharmaceutical company reported a halt in their global research trial. The company, which is working with the University of Oxford and is one of the few waist-deep in the process of developing a COVID-19 vaccination, reported that the halt is a “routine action which has to happen whenever there is a potentially unexplained illness in one of the trials.”

The company is in Phase 3 of their clinical trial in the U.S., as well as Brazil and South Africa, according to the New York Times, and in Phase 2/3 in England and India. AstraZeneca began the third phase of its clinical trial not much longer than a week ago, on Aug. 31.

Phase 3 efficacy trials involve thousands of volunteers, some of which are administered the vaccine in question, and others the placebo.

AstraZeneca and its most close competitors, Moderna and Pfizer, which have each been in phase 3 of their clinical trials since July 27, are backed by the Trump administration’s Operation Warp Speed, a targeted allocation of resources meant to hasten the development of a COVID-19 vaccine. 

The halt of AstraZeneca’s COVID-19 vaccine—AZD1222—is the first made public by its drug maker, and will allow a safety review to take place. 

“A volunteer in the U.K. trial [of AZD1222] had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections,” reported the New York Times. “However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is unclear.”

The vaccine was first developed by Oxford University’s Jenner Institute and Oxford Vaccine Group, according to nih.gov, and was then “licensed to AstraZeneca for further development.” Oxford-Astrazeneca began the third phase of its clinical trial not much longer than a week ago, on Aug. 31

The company stressed in its statement that the safety of their participants is a priority.

“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” said the company in their statement. “We are committed to the safety of our participants and the highest standards of conduct in our trials.”