Posts tagged with "Moderna"

Art by Symara of 360 for use by 360 Magazine

Israel Reopens to International Travelers

For the first time in more than 18 months, vaccinated individual and group travelers from the United States are welcome to enter Israel and explore the country’s rich culture, history, and stunning landscapes.

The Israel Ministry of Tourism announced that as of today, vaccinated tourists from the United States can resume all travel to Israel. After kicking off the pilot reopening program in May of 2021, which initially allowed a select number of tour groups to enter the country, all vaccinated travelers may now visit Israel after the extended closure due to COVID-19 restrictions.

“To say we are excited that Israel is reopening to travelers today is an understatement,” said Eyal Carlin, Tourism Commissioner for North America. “Israel has taken incredible steps to protect its people and visitors and we pride ourselves on ensuring a COVID-safe and unforgettable trip to those who will be entering our beautiful country. With leading vaccination rates and endless opportunities for outdoor activities, we are eager to welcome visitors back with open arms — of course, at a safe social distance.”

Israel’s Prime Minister Naftali Bennett along with several other Ministers within the country (Tourism, Health, Transportation, etc.), have come together and formed the following plan which has been approved by the COVID cabinet and will take effect today, November 1 – with developments and new COVID variants being monitored closely.

“We have been awaiting this moment, to bring back international travelers into our country, for a very long time now,” said Yoel Razvozov, Israel’s Minister of Tourism. “We’re ecstatic to share our country with everyone once again and I’m proud to be working closely with our Prime Minister Naftali Bennett among other Ministers within the country to ensure a thoughtful, safe return to tourism.”

As of today, the guidelines for entry include:

Taking a PCR test 72 hours before an outbound flight, filling out a passenger declaration, and a taking a PCR test upon arrival in Israel (needing to quarantine in hotel until results return or 24 hours pass – the lesser of the two).

To enter the country, one must:

  • Have been vaccinated with two doses of the Pfizer or Moderna vaccine at least 14 days prior to the day of entry into Israel (14 days must have passed since receival of second dose upon arrival into Israel, but no more than 180 days upon leaving Israel – I.e., if it has been six months since the second dose, you will need the booster shot to enter).
    • Those that have received the booster vaccine dose, and at least 14 days have passed since received, can enter Israel.
  • Have been inoculated with one dose of the Johnson & Johnson vaccine at least 14 days prior to the day of entry into Israel (14 days must have passed since second dose receival upon their arrival into Israel, but no more than 180 days upon leaving Israel – I.e., if it has been six months since your second dose, you will need the booster shot to enter).
    • Those that have received the booster vaccine dose, and at least 14 days have passed since received, can enter Israel.
  • Have recovered from COVID-19 and who present proof of the results of a positive NAAT test at least 11 days prior to the day of entry into Israel (no more than 180 days upon leaving Israel).
  • Have recovered from COVID-19 and have received at least one dose of the WHO-approved vaccines.

In-depth guidelines can be found HERE. For more information, please visit the official website for all updates on entry protocols and forthcoming answers to FAQs.

Unvaccinated Americans at Risk of New Variant for use by 360 Magazine

UNVACCINATED AMERICANS AT RISK OF NEW VARIANT

By: Clara Guthrie

In December of 2020, the beginning of the end of the pandemic was set into motion as the first COVID-19 vaccines were administered in the United States to frontline workers. Sandra Lindsay, an ICU nurse from the Long Island Jewish Medical Center, was the very first individual to receive the Pfizer-BioNTech vaccine. The momentous occasion was filmed and live streamed on New York Governor Andrew Cuomo’s Twitter feed. At the time, Lindsay proudly stated, “I want to instill public confidence that the vaccine is safe. We’re in a pandemic and so we all need to do our part.”

Yet, in the six months following Lindsay’s statement of comfort and inspiration, it can be argued that the totality of the American people has not, in fact, done their part. According to data collected by the CDC, 45.1% of the total US population have been fully vaccinated, a number that only increases across age demographics: 77.2% of the population that is 65 years and older have been vaccinated. Additionally, 53.3% of the total population have received at least one dose of the vaccine. However, the rate of vaccination wildly varies when broken down state by state. According to CNN, states like Vermont and Connecticut have vaccination rates that exceed 80%. Meanwhile, other states—a majority of which are in the South—have vaccination rates below 35%.

According to Becker’s Hospital Review, Mississippi currently has the lowest vaccination rate in the country with only 28.86% of their population being fully vaccinated. The CDC reports that fewer than one million residents have received both doses of the Moderna and Pfizer-BioNTech vaccines or one dose of the Johnson and Johnson vaccine, making them fully vaccinated. For reference, their total population is approximately three million people, based on data from the United States Census Bureau in 2019. Following Mississippi for the lowest vaccination rates are Alabama and Arkansas, with 31.86% and 33.3% of their respective populations being fully vaccinated. (As an interesting side note, these three states were also among the first to lift their mask mandates; Mississippi on March 2, Alabama on April 9 and Arkansas on March 30.)

These stark discrepancies in vaccination rates pose legitimate and pressing problems for states and counties that are struggling to vaccinate their citizens. Most concerning in these areas is the increased spread of more contagious strains of COVID-19, specifically the Delta variant. As the World Health Organization explains, the more a virus spreads, “the more opportunities it has to undergo changes.” These changes can directly alter both spreadability and severity of the virus. Earlier this year, the UK variant (or the Alpha variant) gained international attention because it was more transmissible than earlier COVID-19 strains. The Delta variant—which experts are now predicting will become the dominant strain in the United States—is even easier to spread between individuals. Moreover, the Delta variant is more unpredictable in how it affects individuals, in comparison to other strains. Steve Edwards, the CEO of CoxHealth, spoke on the variant and said, “We can’t tell why one patient is doing poorly and one is doing well. There’s just something different about how this variant is affecting the immune system of our patients.”

Due to this new Delta strain, doctors are doubling down on their insistence that citizens must get vaccinated to protect themselves and others. Dr. Rochelle Walensky, director of the CDC, said, “After two doses—reminding you, get your second dose—after two doses, you are protected from that Delta variant.” Dr. Paul Offit, a pediatrician who specializes in infectious diseases and vaccines, added, “Unless we vaccinate a significant percentage of the population before winter hits, you’re going to see more spread and the creation of more variants, which will only make this task [of ending the pandemic] more difficult.” These claims are backed by a recent study conducted by Public Health England that found that the Pfizer-BioNTech vaccine is 96% effective against hospitalization caused by the Delta variant after two doses.

Therefore, in states like Mississippi, Alabama and Arkansas, there have been significant upsurges in cases of this new Delta variant, according to the aforementioned CNN article. Like what the country experienced when COVID-19 cases swelled during the winter months of late 2020 and early 2021, hospitals are again filling up in these lesser vaccinated states. According to the CDC, as of June 17, 2021, Mississippi was averaging 119 new cases of COVID-19 every seven days. Similarly, Alabama was averaging 190 new cases, and Arkansas was averaging 247 new cases every seven days. Meanwhile, Vermont was averaging only six new cases each week. It is important to note that, although slow and incomplete, some progress has been made in these southern states; Mississippi’s average weekly cases peaked in early January at around 2,324 new cases. But this progress is far from over and not yet something to celebrate.

Doctors and legislators now need to turn their attention towards pushing the vaccine into communities that are currently resistant to its presence or that are being faced with systemic barriers blocking them from receiving it. Scott Gottlieb, former commissioner of the FDA, said, “Now we need to think about trying to push out the vaccine into community sites where people could get it delivered to them through a trusted intermediary, that’s going to mean doctors’ offices, schools, places of employment.”

This continued effort to vaccinate American citizens becomes increasingly important when one considers that the pandemic is disproportionately affecting racial and ethnic minorities. America has continually fallen short of health equity, the concept that all citizens have equal opportunity for fair treatment and being healthy, and it has been brought to the forefront during the pandemic. Factors including discrimination, access to healthcare, employment as essential workers and housing conditions all pose challenges to achieving health equity. Thus, American Indian citizens and Alaska Natives represented 1,216.1 COVID-related hospitalizations per 100,000 people in America from March 1, 2020 to June 5, 2021. Black citizens represented 997.8 COVID-related hospitalizations, and Hispanic and Latinx citizens represented 993.5 hospitalizations. White Americans represented only 354.7 COVID-related hospitalizations across that same timespan.

Moreover, vaccination rates sorted by race also point towards immense health inequity. Only 1.0% of the American Indian and Alaska Native population, 9.1% of the Black population, and 15.1% of the Hispanic and Latinx population have received at least one dose of the vaccine. In stark contrast, 60.2% of the white population have received their first dose.

To stop the spread of the Delta variant, reduce the further mutation of the COVID-19 virus and protect the American population, vaccinations remain of the utmost importance, per the repeated recommendations of the CDC and other medical professionals.

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.

Despite progress in vaccination efforts and decreasing corona virus cases, new virus mutations pose critical cause for concern. In countries across the Asia-Pacific region, a new, more infectious variant–the Delta variant–is causing stay-at-home orders to be again put into place. This new variant was first identified in India, and has quickly been spreading. As restrictions begin yet again, countries across the globe are grappling with the harrowing fate that the pandemic is far from over.

In some major Australian cities, such as Sydney, Brisbane, Perth, and Darwin, residents have been forced into strict lockdowns. Flights are even being banned due to the new threat, with Hong Kong barring British entry. Indefinite stay-at-home orders were extended by the Malaysian government on Monday. In Malaysia, the new variant is especially threatening, as only 6% of the country’s residents are fully vaccinated, reports the New York Times.

India has faced a devastating, major second wave of coronavirus due to the Delta Plus variant, a sub-lineage of the Delta variant. This past spring, the dangerous variant caused thousands of deaths per day, and forced residents into partial stay-at-home orders, yet again. Much like in Malaysia, in India only 5% of the population is fully vaccinated. In fear of a third wave of the virus, Maharashtra’s chief minister, Uddhav Balasaheb Thackeray, has authorized the use of a fourth vaccine in an attempt to increase vaccination supplies.

In good news, the Covid-19 vaccination is largely effective against the new Delta variant. However, this Delta variant is 50 percent more contagious than several of the other variants of concern, such as the Alpha variant.

As countries continue reopening, people look toward high vaccination rates to change the coronavirus game. In the U.S. and Britain, officials are planning to, or already have, lift most pandemic restrictions. White House secretary, Jen Psaki, recently announced that the United States would send two million doses of the Pfizer-BioNTech vaccine to Peru. Additionally, the U.S. looks to send 2.5 million doses of the Moderna vaccine to Pakistan. A third shipment of 1.5 million Moderna vaccination doses will be sent to Honduras from the United States.

Looking ahead to this weekend, July 30-Aug 1, 2021, the return of  a major musical festival threatens a super-spreader event. The highly infectious variant of COVID-19 has again created a surge in the number of recent coronavirus cases. As festival fans migrate to Chicago for Lollapalooza – the first of which held since 2019 – the Windy City braces for the potentially devastating impact.

Fortunately, the festival is taking several precautions to prevent the spread of the virus. All attendees must be fully vaccinated or show proof of a negative COVID-19 test taken within 72 hours of event entry. However, the Better Business Bureau (BBB) warns that not all guests will be honest about meeting these requirements.

The head of the BBB, Steve Bernas, warns of the potential for festival scammers who fabricate fake vaccine cards and negative test results. “We anticipate a double whammy this year not only the tickets but also the vaccine cards,” Bernas said in a statement. “The scammers will be out in full force.” He continues, cautioning ticket buyers to be on high-alert: “Just like finding tickets, there are countless ways for consumers to find vaccinations cards online, with online marketplaces, ticket sellers, resellers and the like…and unfortunately, some of them are rip-offs”

One of Chicago’s top coronavirus experts, Dr. Emily Landon, also weighed in on the weekend’s festivities. She argues that Lollapalooza’s 72-hour testing window is too lenient, and that the city is inviting in a massive spike of cases by holding the concert. NBC Chicago reports that Dr. Emily Landon commented, “Lolla has let us down with respect to how vigorously they’re restricting people based on the things that they sort of initially told us (about how) ‘we’re going to be really strict’ and now it’s like they’ve lightened up quite considerably on checking vaccines and negative tests.”

Chicago Department of Public Health Commissioner Dr. Allison Arwady expressed concerns similar to Dr. Emily Landon’s. Recognizing the importance of getting vaccinated, she commented the following in a coronavirus update last week: “We want people to have a good time and we want this to be as safe as it can be…And so certainly we’ll be watching that just as we do any other gathering, but I am more concerned about the many people who have not chosen the COVID vaccine.”

Still, Chicago’s mayor and top doctor still haven’t wavered their support for the much-loved music festival. Chicago Mayor Lori Lightfoot expressed her desire the event to occur as safely as possible, though she didn’t comment on the recent uptick in case numbers and coronavirus hospitalizations. NBC 5 Chicago reports on the current coronavirus statistics in the city:

“Chicago’s average daily number of new cases rose to 130 per day early Monday – a 76% jump compared to last week. The city’s average daily case rate was at 90 per day last week and 41 per day the week before that, meaning it’s more than tripled in roughly three weeks. However, it is still significantly lower than the more than 700 cases per day the city was seeing earlier this year and last, before vaccines were widely available.”

Additional safety measures, including mandatory mask-wearing on public transport, will also be enforced. The Chicago Transit Authority is offering reduced ticket rates this weekend for Lollapalooza travelers.

As Summer winds down, COVID-19 cases are beginning to rise yet again. Several virus variants, including the new Lambda variant, are causing major concern among Americans. In an attempt to quell concern, several cities have launched vaccine passport programs.

Across the United States, metropolitan hubs including New York, San Francisco, and New Orleans are requiring residents to show proof of vaccination before entering indoor spaces. That means that visiting gyms, concerts, restaurants, and more will require citizens to have both of their required vaccination shots. Vaccine passports are not being put in place to stop public gatherings, but are intended to creater safer enviroments outside of one’s home.

However, many Americans are opting to stay indoors yet again, thanks to new variant threats. The Lambda variant, which was first detected in Peru and is quckly spreading through South America, is causing concern among citizens. The New York Times reports that “On June 14, the World Health Organization designated it as a “variant of interest,” meaning, essentially, that experts suspect it could be more dangerous than the original strain.

However, it has been reported that the Lambda variant is likely not as contagious as other deadly virus mutuations, like the Delta variant. And fortunately, the Lambda variant is able to be combatted by the vaccines that have currently rolled out across the U.S. The New York Times records the climbing numbers of the Lambda variant, “As of mid-June, Lambda had been reported in 29 countries, territories or areas, according to a June 15 update from the W.H.O. The variant had been detected in 81 percent of coronavirus samples sequenced in Peru since April, and 31 percent of those in Chile to date, the agency said.” However, assessing the virus has been difficult due to Latin America’s limited ability to conduct geonomic surveillance and follow-up laboratory studies, reports the NYT. Scientists and medical professionals around the world are currently conducting research to better understand this new variant and its implications.

HotelPlanner’s Delta Variant Coverage:

America’s comeback is in jeopardy. The Delta variant is surging, prompting concerns that we need another lockdown. Travel executives are already huddling, discussing potential next steps to both protect guests and their businesses’ bottom lines. Americans were traveling in record numbers, and people are wondering if this could slow down the sector. How could the Delta variant, and other emerging variants, impact travel?

“We are watching the rapid uptick in Delta variant case infections closely, says Tim Hentschel, Co-Founder and CEO of HotelPlanner. “Although some families may choose to curtail their summer travel plans, we remain confident that the vast majority of Americans who were planning to travel this summer will keep their plans, while exercising more caution with crowds and destination selection. For those who are already vaccinated, the Delta variant shouldn’t be a deterrent to summer travel because they should be protected.”

ABOUT HOTELPLANNER

HotelPlanner is a leading travel technology company that combines proprietary artificial intelligence and machine learning capabilities, and a 24/7 global gig-based reservations and customer service network, to quickly and seamlessly serve all traveler hotel & accommodation needs from a single platform.

HotelPlanner is one of the world’s top providers of individual, group, and corporate travel bookings, specializing in unique “Closed User Group” discount rates.

Founded in 2004, HotelPlanner has enduring partnerships with the world’s largest Online Travel Agencies, well-known hotel chains, individual hotels, online wedding providers, ancillary lodging providers, corporations, sports franchises, universities, and government agencies.

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.”