Per the State of Maryland—Governor Larry Hogan and the Maryland Department of Health (MDH) today announced that more than one million Marylanders have received their COVID-19 bivalent booster since September in order to be COVIDReady in time for the holidays. “Through our COVIDReady plan, Maryland continues to be one of the most vaccinated and boosted states in the country,” said Governor Hogan. “We are grateful for the everyday vigilance of Marylanders, and the leadership of our GoVAX ambassadors, who have reminded us that we truly are all in this together.”
Recognition For GoVax Ambassadors. The state is recognizing the efforts of the state’s GoVAX ambassadors from all walks of life with governors’ citations and a new ad, which will play on WBAL during Thanksgiving programming. First launched in January 2021, the initial GoVAX campaign highlighted around a dozen Marylanders—including former UMBC President Dr. Freeman Hrabowski, Del. Joseline Peña-Melnyk, and Associate Professor of Medicine at the Johns Hopkins University School of Medicine Dr. Kathleen Page.
Enthusiasm quickly grew for the campaign, attracting many more ambassadors, including community leaders, health care workers, faith leaders, and Maryland families. Each of these Marylanders have been essential in sharing information about the safety and effectiveness of COVID-19 vaccines and boosters, helping Maryland earn national recognition for its COVID-19 response.
“Surpassing one million COVID-19 bivalent booster shots administered since September shows that Marylanders understand the importance of staying COVIDReady,” said MDH Secretary Dennis R. Schrader. “Fighting COVID-19 has always been a statewide effort, and Marylanders have pulled together to protect ourselves and our families against this virus by getting boosted. We are grateful for our GoVAX ambassadors who have played a role in this effort.”
COVIDReady Maryland. Marylanders can protect themselves from flu and COVID-19 by getting a “Flooster,” a flu shot and COVID-19 booster. It’s safe to get both at the same visit and is the best way to protect against severe illness and death. As always, Marylanders are encouraged to practice basic health hygiene by washing your hands, covering your cough, and staying home from work and school when sick. This helps slow the spread of respiratory illness like RSV as well, which can be dangerous to small children and older adults and doesn’t have a vaccine.
Find a vaccine provider at covidvax.maryland.gov or by calling 1-855-MDGOVAX (1-855-634-6829). For more information about COVID-19 vaccines in Maryland, visit covidLINK.maryland.gov. For the most recent Maryland COVID-19 vaccine data, visit coronavirus.maryland.gov.
Maryland Governor Larry Hogan announced today that he has tested positive for COVID-19. In a tweet Hogan said, “Just wanted to let Marylanders know that after testing positive for COVID-19, I am working from home. Fortunately, I’m up to date on my boosters and my symptoms are minimal” and directed residents to visit covidvax.maryland.gov to find a nearby vaccine clinic.
Last week Hogan announced that over 710,000 Marylanders have received the COVID-19 bivalent booster. Addition COVID-19 information courtesy of the State of Maryland below:
State Continues Joint COVID-19/Flu Shot Campaign.
Earlier this month, state officials further expanded COVIDReady Maryland, the state’s long-term preparedness plan, by adding the COVID-19 bivalent vaccine booster shot for residents five years old and older. In addition, adults now have the option of receiving a Novavax monovalent booster if they have not previously received a booster and if they cannot or will not receive mRNA vaccines.
To date, more than 710,000 Marylanders have received the COVID-19 bivalent booster, further protecting themselves against severe illness, hospitalization, and death. With flu hospitalizations also increasing earlier and faster than in previous years, state health officials continue to encourage Marylanders to get their COVID-19 and flu shots simultaneously. Starting next week, state health officials will launch a new “Flooster” television, radio, and social media ad campaign to amplify this message.
The state maintains a robust vaccination infrastructure of more than 900 providers. Some locations offer both COVID-19 and flu shots during the same visit. Find a vaccination clinic near you.
Enhanced Awareness and Outreach. The state’s GoVAX Call Center (1-855-MD-GOVAX) continues to be available seven days a week. In addition to providing a number of services for help with getting tested and boosted, the call center is launching a texting campaign focused on preventing COVID-19, flu, and RSV.
Per the State of Maryland:
Directs Hospitals to Utilize Recent $25 Million in State Funding to Prioritize Pediatric ICU Staffing
Expands Critical Care Coordination Center to Include Pediatric Surge Operations
State Surpasses 700,000 COVID-19 Bivalent Boosters Administered
Launching New Statewide COVID/Flu PSA Campaign Next Week
ANNAPOLIS, MD—As hospitals in the region and across the country experience an increase in Respiratory Syncytial Virus (RSV) admissions, Governor Larry Hogan today announced a series of new mitigation actions, along with preparedness efforts for potential fall and winter COVID-19 and flu surges in Maryland. “After meeting with our multi-agency public health task force yesterday and reviewing all of the data, I am announcing these steps to give our hospitals more tools to expand bed capacity for pediatric patients,” said Governor Hogan. “We also continue to encourage Marylanders to be COVIDReady, so that we remain one of the most vaccinated and boosted states, and stay ahead of the virus.”
Hospitals Directed to Utilize Additional State Funding to Prioritize Pediatric ICU Staffing. RSV hospitalizations are increasing earlier and more rapidly than in previous years, with the 0-2 age group comprising 57% of hospitalizations. On October 14, the Maryland Department of Health announced $80 million in additional funding for healthcare providers across the state. Hospitals will receive $25 million and have been directed in award letters issued today to utilize these resources to increase the hiring and recruitment of staff. For facilities with pediatric ICU and/or inpatient beds, awards should prioritize staffing those units appropriately before considering other non-pediatric units. All hospitals are also strongly urged to collaborate with neighboring hospitals on pediatric patient care coordination.
Critical Care Coordination Center Expanded to Include Pediatric Surge Operations. To help mitigate an increase in hospital admissions, particularly among children experiencing RSV, Rhinovirus, or Enterovirus D68, the Maryland Institute for Emergency Medical Services Systems (MIEMSS) will expand its Critical Care Coordination Center (C4) capability to include pediatric surge operations. This action will optimize existing capacity, increase statewide capacity of pediatric ICU beds, and facilitate the transfer of pediatric patients to available beds in Maryland hospitals and Children’s National Medical Center in Washington, DC.
State Continues Joint COVID-19/Flu Shot Campaign. Earlier this month, state officials further expanded COVIDReady Maryland, the state’s long-term preparedness plan, by adding the COVID-19 bivalent vaccine booster shot for residents five years old and older. In addition, adults now have the option of receiving a Novavax monovalent booster if they have not previously received a booster and if they cannot or will not receive mRNA vaccines.
To date, more than 710,000 Marylanders have received the COVID-19 bivalent booster, further protecting themselves against severe illness, hospitalization, and death. With flu hospitalizations also increasing earlier and faster than in previous years, state health officials continue to encourage Marylanders to get their COVID-19 and flu shots simultaneously. Starting next week, state health officials will launch a new “Flooster” television, radio, and social media ad campaign to amplify this message.
The state maintains a robust vaccination infrastructure of more than 900 providers. Some locations offer both COVID-19 and flu shots during the same visit. Find a vaccination clinic near you.
Enhanced Awareness and Outreach. The state’s GoVAX Call Center (1-855-MD-GOVAX) continues to be available seven days a week. In addition to providing a number of services for help with getting tested and boosted, the call center is launching a texting campaign focused on preventing COVID-19, flu, and RSV.
Montgomery County Public schools sent out the following community message from MCPS Medical Officer Patricia Kapunan, M.D. on Thursday, August 25:
Dear MCPS Community,
We are so excited to be back together next week for the new school year! As we return to shared spaces, the health and wellness of our students and staff remains a top priority. We have more tools, experience and knowledge than ever to help reduce the impact of COVID-19 in our school community. Here are some important things to know about vaccination, testing and masking as staff and students return to school:
COVID-19 Vaccination Helps Our School Community
Vaccines are an important way to lower individual risk of severe complications from COVID-19 infection. A high vaccine coverage rate helps reduce the overall burden of COVID-19 on the school community and helps keep learning going, as individuals with milder symptoms will miss fewer school or work days. We continue to strongly recommend students receive all recommended COVID-19 vaccines and boosters for which they are eligible. At this time, COVID-19 vaccination is required for staff unless approved for a medical exemption. We will continue to provide opportunities for students, staff and family members to receive COVID-19 vaccines atafter-school and weekend events.
Rapid Testing for COVID-19 for a Strong School Year Start
Montgomery County Public Schools (MCPS) is encouraging at-home rapid testing for COVID-19 as staff and students return to school. Testing is an important way to identify individuals actively positive for COVID-19 who should temporarily isolate in order to prevent further transmission and keep our school community as healthy as possible.
End-of-summer activities, such as returning from travel or getting together with larger groups, can increase the risk of exposure to COVID-19. Staff and students may consider testing even after school begins, following Labor Day holiday travel or after higher-risk social events that may coincide with the start of the school year. Testing is not mandatory. We are depending on our staff and families to consider their exposure risk, and test and report positive results accordingly.
Test kits will be available at schools, at the MCPS Annual Back-to-School Fair on Aug. 27, and upcoming school-based weekend vaccination clinics on Aug. 27 and Aug. 28. Free rapid test kits are also available to Montgomery County residents at most public library locations, or by mail for home delivery from the U.S. government. Only positive test results need to be reported using theMCPS COVID-19 Reporting Form. Individuals who have a positive COVID-19 test should report their positive result and follow CDC guidelines for isolation.
Masking
As of today, the CDC COVID-19 Community Risk Level for Montgomery County is “low.” At this time, masking is not mandatory in MCPS buildings or buses in most situations. Health room staff actively engaged in patient care or anyone assisting with medical procedures must follow infection control guidelines from the DHHS and the CDC, including wearing a mask when required.
In addition, masking may be temporarily required for individuals or groups, in certain circumstances:
- A student develops symptoms of COVID-19 during the school day and presents to the health room for evaluation
- A student has tested positive at school for COVID-19 and is awaiting pick-up
- In outbreak situations, as an alternative to quarantine for exposed individuals who do not have symptoms of COVID-19
- For students or staff recovering from COVID-19 who have completed at least five full days of isolation, and feel well enough to return to school or work.
Recommendations and requirements for masking can be expected to change during the school year, as COVID-19 data trends and science change. For individuals who cannot safely mask, other prevention measures will be used.
Please remember that all staff and students are supported in their decision to wear a mask for individual protection, at any risk level. MCPS will continue to provide masks for staff and students for use during the school day.
The new school year is just around the corner! Let’s work together to keep our school community well, as we return with excitement, renewed purpose and joy.
Sincerely,
Patricia Kapunan, M.D.
MCPS Medical Officer
Per Montgomery County:
For Immediate Release: Tuesday, July 12, 2022
Health officials today released the COVID-19 Epidemiology Surveillance Report for Montgomery County. The report, Coronavirus Disease 2019 (COVID-19) in Montgomery County, Maryland 2020-2022, highlights disease burden of COVID-19 among residents, details how Montgomery County compares to the State and the U.S., and details how the County’s Department of Health and Human Services’ (DHHS) programs respond to the pandemic.
The report provides statistics and epidemiology profiles of COVID-19, including infections, testing, hospitalization, deaths, vaccinations, outbreaks and contact tracing. According to the CDC’s COVID-19 community level map, as of March 2022, when the report’s data were last updated, transmission in Montgomery County was in the “low” category. As of late June, the transmission level in the community is in the “medium” category. This is likely to change as new variants and sub-lineages continue to evolve over time.
“Montgomery County fares better than the State and national averages for most indicators related to COVID-19, but vulnerable population subgroups and communities disproportionally impacted by the pandemic remain a top priority to address through the lens of social determinants,” said acting County Health Officer James Bridgers. “Our goal is to implement the evidence-based and data-driven approaches to enhance our programs and services to respond to the pandemic proactively to meet the public health needs of Montgomery County.”
Key findings of the report include:
- Female residents aged 20 to 34 years, non-Hispanic black residents aged 20 to 24 years, and Hispanic residents aged 20 to 64 have the highest cumulative case rates.
- Test positivity rates were highest for the first and third waves of the pandemic.
- The highest number of monthly positive cases occurred in December 2021 and
January 2022. - There have been 2,039 deaths in Montgomery County since the start of the pandemic, with the highest number of monthly deaths occurring in April and May 2020.
It has been a more than two years since the first three cases of COVID-19 in Maryland were confirmed in Montgomery County on March 5, 2020. In addition to the morbidity and mortality associated with the disease, examples of the pandemic’s profound impacts on the community include burnout seen in health workers, remote learning in schools on students, parents, teachers, and businesses having to adapt with workers having to isolate.
The report completes a core function of public health: surveillance and data collection, analysis and interpretation for disease prevention and control. The goal is to present the data to the community so that it can serve as a source of knowledge, bring attention to areas of success and weakness, and potentially serve as a basis for further analysis by stakeholders to design appropriate programming and interventions to address gaps in outcomes.
For the latest updates on COVID-19, visit the COVID-19 website. A downloadable report is available on the Department of Health and Human Services website.
The US Centers for Disease Control and Prevention will no longer require international travelers coming to the U.S. to provide a negative COVID-19 test result, according to CNN. The change will go into effect at midnight on June 12. The requirement has been in place since January 2021. A formal announcement is expected today from the White House.
The Associated Press reports that the CDC determined that the requirement is no longer necessary and that the agency would “reevaluate the need for the testing requirement every 90 days and that it could be reinstated if a troubling new variant emerges.”
We will post an update when more information becomes available.
BREAKING: The Biden administration is lifting its requirement that international air travelers to the U.S. take a COVID-19 test within a day before boarding their flights, a senior administration official says. The mandate will expire on Sunday. https://t.co/xi5LTyIaSM
— The Associated Press (@AP) June 10, 2022
“We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “We’re encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19.”
The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine.
The study employed descriptive endpoints, assessing safety and the immunological responses of different CIC vaccine formulations. A Design of Experiments (DOE) modeling-based approach was used to design the trial, enabling more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches. The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery.
Both protein-based vaccines used in the trial were formulated with the patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. These data support advancement to a Phase 2 confirmation trial, expected to begin by the end of 2022.
Data from the trial were presented at the World Vaccine Congress (WVC) in Washington, DC.
At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its stand-alone influenza candidate, previously referred to as NanoFlu, which met its primary immunogenicity endpoint. These results have previously been published in The Lancet.
Neither NVX-CoV2373 or the influenza vaccine candidate have been authorized or approved for use in the U.S. by the U.S. Food and Drug Administration.
- NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
- Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
- Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
- The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
For additional safety information, including the full Summary of Product Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.
The Phase 1/2 CIC vaccine trial is evaluating a combination of Novavax’ recombinant protein-based NVX-CoV2373 and influenza vaccine candidates and patented saponin-based Matrix-M adjuvant in a single formulation. The trial will evaluate the safety, tolerability and immune response to the combination vaccine in 642 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be dosed on Day 0 and again at Day 56. The trial is being conducted in Australia at 10 sites. (ClinicalTrials.gov Identifier: NCT04961541)
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax’ influenza vaccine, previously known as NanoFlu, is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences, and contains Novavax’ patented saponin-based Matrix-M adjuvant. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide.
For more information, visit www.novavax.com and connect with us on LinkedIn.
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, including the Phase 2 confirmation trial expected to begin by the end of 2022, the ongoing development of NVX-CoV2373, NanoFlu, its COVID-seasonal influenza investigational vaccine candidate, and its COVID-Influenza Combination Vaccine, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, additional worldwide authorizations of NVX-CoV2373, the potential impact and reach of Novavax and its COVID-19 Influenza Combination Vaccine in protecting populations, and the efficacy, safety and intended utilization of the COVID-19 Influenza Combination Vaccine, NanoFlu, and NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Erika Schultz | 240-268-2022
[email protected]
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
[email protected]
The Associated Press is reporting that the CDC will now be extending the mask requirement for travel until May 3rd to “allow more time to study the BA.2 omicron subvariant that is now responsible for the vast majority of cases in the U.S.”
Yesterday we reported that residents will no longer be required to wear face coverings when they are passengers on Metro, Metro Bus, Ride-On, and in taxis (including Uber & Lyft) after April 18. That is no longer the case.
According to the CDC, “in order to assess the potential impact the rise of cases has on severe disease, including hospitalizations and deaths, and health care system capacity, the CDC order will remain in place at this time.”
In March, the Transportation Security Administration (TSA), at the request of the CDC, extended its face mask requirement for, “individuals across all transportation networks throughout the United States, including at airports, onboard commercial aircraft, on over-the-road buses, and on commuter bus and rail systems” until April 18. It was originally set to expire on March 18.
The Montgomery County Department of Transportation supplies masks for all riders who don’t have one.
The Associated Press is reporting that the CDC will now be extending the mask requirement for travel until May 3rd to “allow more time to study the BA.2 omicron subvariant that is now responsible for the vast majority of cases in the U.S.”
Yesterday we reported that residents will no longer be required to wear face coverings when they are passengers on Metro, Metro Bus, Ride-On, and in taxis (including Uber & Lyft) after April 18. That is no longer the case.
According to the CDC, “in order to assess the potential impact the rise of cases has on severe disease, including hospitalizations and deaths, and health care system capacity, the CDC order will remain in place at this time.”
In March, the Transportation Security Administration (TSA), at the request of the CDC, extended its face mask requirement for, “individuals across all transportation networks throughout the United States, including at airports, onboard commercial aircraft, on over-the-road buses, and on commuter bus and rail systems” until April 18. It was originally set to expire on March 18.
The Montgomery County Department of Transportation supplies masks for all riders who don’t have one.
All passengers are required to wear face coverings when traveling on @RideOnMCT buses, Flash, @Metrobusinfo @Metrorailinfo Taxis, and On-demand car services until April 18.
😷All MCDOT Ride On buses have a supply of face coverings for those who cannot provide their own😷 pic.twitter.com/HZpB7rsh9x
— MCDOT (@MCDOTNow) April 12, 2022
Need a mask? Don't worry, Ride On has you covered. All of our buses are equipped with free masks for our riders. The federal mask mandate is in place through April 18, 2022. pic.twitter.com/FbO3SVpawr
— Ride On Bus (@RideOnMCT) April 12, 2022
John Hopkins University in Baltimore and Georgetown University in D.C. will both be temporarily reinstating mask mandates due to an increase in COVID-19 cases among students, according to WTOP.
According to the report, the indoor mask requirement goes into effect today, April 7, on the Main and Medical Center campuses at Georgetown.
At Johns Hopkins, masks will be required in all classrooms, as well as in common areas of residence and dining halls.
Georgetown students will also need to take a PCR test after Easter break the week of April 18, unless they have tested positive within the previous 90 days.
John Hopkins will be moving to twice-weekly testing for all undergraduate students for at least this week and the next two weeks (through April 22). The school will then re-evaluate and determine whether the increased testing remains necessary.
Full statements from Georgetown University and John Hopkins below:
Georgetown University:
We are temporarily reinstating an indoor mask requirement for the Main and Medical Center campuses, beginning Thursday, April 7. Please also see information below regarding COVID-19 testing and isolation procedures for undergraduate students.
We are taking these steps in response to a significant increase in COVID-19 cases on the Main Campus and Medical Center campuses this week, particularly among undergraduate students. We have not seen a comparable increase in cases on the Law Center campus. Thankfully, with the vast majority of our community up to date on vaccination, we are not seeing cases involving severe illness.
This increase is partly due to the impact of the BA.2 Omicron subvariant. BA.2 is now the dominant strain in the United States, including in DC and on our campuses. While recent studies show that BA.2 does not cause more severe illness than the initial Omicron variant, they also show that BA.2 is even more transmissible.
These circumstances present a challenge, but we have learned to adjust our mitigation measures to respond to changing conditions throughout the pandemic. Another adjustment is needed now to curb transmission on campus.
Temporary Reinstatement of Indoor Mask Requirement
Beginning Thursday, April 7, everyone will need to wear a mask indoors on the Main and Medical Center campuses, except when in their personal residence or private office or while actively eating or drinking. This requirement will be in effect until further notice.
We strongly recommend wearing a properly-fitting, high-quality mask (e.g., N95, KN95), which are available for free on campus. We also strongly recommend that all members of our community wear a mask when attending indoor social gatherings and events off campus as well.
In the March 18 message, we shared that the University’s mask-optional policy is contingent on public health conditions and that we may need to reinstate the indoor mask requirement or other restrictions for short periods.
We will continue to monitor campus case numbers and positivity rates, COVID-19 community levels in DC and nationally, and global developments relating to the pandemic, which will inform our decision of when to resume the mask-optional policy.
COVID-19 Testing
All undergraduate students will need to take a PCR test after Easter break the week of April 18, unless they have tested positive within the previous 90 days. Please schedule your test in advance via the One Medical app or website. If you get tested through a third-party provider (i.e., not One Medical), please report your result through the COVID-19 Test Result Submission form.
If you have been exposed to anyone with a known COVID-19 infection, please get tested on day 5 following your exposure.
Please also get tested when selected to participate in the University’s random asymptomatic testing.
Isolation Procedures for Undergraduate Students
We are nearing full capacity at our campus hotel and have secured additional isolation space at a nearby hotel.
Residential students who test positive may need to share a hotel room or isolate in their campus residence, which means that COVID-positive and negative students may need to be housed together in the same room or apartment.
Students who test positive who prefer to isolate at home may travel home by private transportation, wearing a properly-fitting, high-quality mask (e.g., N95, KN95) while in a vehicle with others, but should not travel home by public transportation (e.g., plane, train, ride-share).
Symptom Monitoring
As a reminder, please stay home if you have symptoms of COVID-19, except to get tested, and report them to the Public Health team by completing the COVID-19 Symptom Check-In survey.
Dining and Events
We encourage grab-and-go dining and eating in the outdoor tents on campus, whenever possible. Events may continue as planned.
We’ve developed the frequently asked questions below to provide additional information, which we hope you will find helpful.
As we’ve done multiple times before, we will get through this surge together and continue to thrive despite these short-term restrictions.
Sincerely,
Ranit Mishori, M.D., MHS, FAAFP
Professor of Family Medicine, Vice President and Chief Public Health Officer
John Hopkins University:
Dear Undergraduate Students,
Since Spring Break, we have received reports of COVID cases among undergraduates who have recently traveled or who were exposed to someone who has recently traveled. Nearly 100 undergraduate students have reported a positive test since April 1, with cases evenly split among residential and non-residential students. Consistent with what we have seen this term, many students who tested positive are asymptomatic, and the rest are experiencing only mild symptoms.
To help monitor the situation, we are moving to twice-weekly testing for all undergraduate students for at least this week and the next two weeks (through April 22). We will then re-evaluate and determine whether the increased testing remains necessary. We are also temporarily reinstating masking requirements for all people (students, staff, faculty, contractors, visitors, and guests) in common areas of the residence halls and in university dining facilities, except when actively eating or drinking. This is in addition to the required masking in classrooms. The university will continue to provide free, high-quality masks at asymptomatic testing sites.
In order to effectively manage our inventory of off-campus isolation housing, we may also adopt the isolation-in-place protocols outlined in a January message for residential undergraduates. In that case, we would prioritize off-campus isolation housing for residential students most in need, such as those with medical conditions that place them at higher risk from COVID; those who are experiencing more serious presentations of COVID; or those whose living arrangements may make it difficult to isolate (such as students living in doubles as opposed to suites with individual bedrooms). We currently are not accommodating our off-campus COVID-positive students in university isolation housing. However, they should continue to use the resources of Student Health and Wellness and Student Outreach and Support.
If students are asked to isolate in place, they must remain in their rooms and are not to leave unless there is a building or medical emergency. They will have meals delivered to their door, and mail, laundry, and trash removal services will be made available. Isolating students – whether in their rooms or in off-campus housing — are also instructed to communicate with their professors and create plans for handling absences from classes, assignments, and exams.
A member of the COVID Support Team will reach out to you as a follow up to answer any questions or concerns you may have about the isolation process and resources available to you.
We want to assure you that we are taking these precautions so that other students in the university’s residence hall buildings are not put at risk. To help students monitor their own health, we are making self-tests available to all residential students. These tests supplement, but do not replace, the mandatory asymptomatic saliva testing requirements that are in place. Test kits can be picked upfrom 1:30 to 4:30 p.m., Monday through Friday, in the Wolman Housing Office or AMR II Residential Life office.
We appreciate your continued flexibility and will provide to updates as conditions warrant.
Sincerely,
Kevin Shollenberger
Vice Provost for Student Health and Well-Being
- U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current FDA approved or emergency use authorized-vaccines
- NVX-CoV2373 will be evaluated in a head-to-head boosting trial in the United Arab Emirates to assess boosting options for a large number of the world’s population that have previously been vaccinated with inactivated COVID-19 vaccine
GAITHERSBURG, Md., March 25, 2022/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine, is included in two trials now underway to evaluate its vaccine’s safety, immunogenicity, and reactogenicity as a booster amidst the ongoing COVID-19 pandemic. Both studies have initiated participant enrollment and will help to extend knowledge of how a range of vaccines, including Novavax’ COVID-19 vaccine, can be used as boosters following primary immunization.
“Additional COVID-19 booster studies are important to support vaccine choice for individuals, healthcare providers, and public health authorities,” said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. “Our COVID-19 vaccine has already been recommended by multiple national policy bodies for both primary vaccination and booster settings in individuals 18 years of age and older. We look forward to adding to this body of evidence to support the expanded use of our protein-based vaccine.”
Novavax is participating in an ongoing Phase 1/2 trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) to assess homologous and heterologous boosting regimens in participants who received a primary series of a COVID-19 vaccine which has received full approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Participants will be given a third dose (> 12 weeks later) of either NVX-CoV2373 or one of the three COVID-19 vaccines that have already received EUA or full authorization from the FDA. The study is enrolling approximately 1,130 healthy individuals aged 18 years or older, about 180 of whom will receive NVX-CoV2373 as a heterologous booster. The trial is being conducted at approximately 10 clinical research sites and its primary objectives are to evaluate safety, reactogenicity, and immunogenicity of delayed heterologous or homologous vaccine doses after EUA dosed vaccines. Participants will be followed for 12 months, with topline results expected later this year and full results expected in 2023.
Novavax’ COVID-19 vaccine is also being evaluated in an observer-blinded Phase 3 study in the United Arab Emirates (UAE) to assess homologous versus heterologous boosting of participants who have already been immunized with Sinopharm’s COVID-19 vaccine. The safety and immunogenicity of a single booster dose of Novavax’ COVID-19 vaccine in adults previously vaccinated with Sinopharm’s COVID-19 vaccine will be evaluated. The study is enrolling approximately 1,000 participants aged 18 years or older at two centers in Abu Dhabi with the goal of providing data to support boosting with NVX-CoV2373 in the large number of individuals who have been vaccinated with inactivated vaccines globally. Participants will be followed for six months, with full results expected during the fourth quarter of 2022. The Ministry of Health and Prevention approved NVX-CoV2373 for emergency use in the UAE in December.
For more information about the NIAID-sponsored study, read here on clinicaltrials.gov. For more information about the study in the UAE, read here on clinicaltrials.gov. NVX-CoV2373 has not yet been authorized for use by the FDA, nor has it received heterologous or homologous booster approval in all the countries where it’s been authorized.
- NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
- Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
- NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
- Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
- The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants aged 18 years and older, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).
A trial conducted in the U.K. with 14,039 participants aged 18 years and older was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.comand connect with us on Twitter, LinkedIn, Instagram and Facebook.
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373 and NanoFlu, its COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, and the efficacy, safety and intended utilization of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.govand www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
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Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
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SOURCE Novavax, Inc.
