Search API | Vax-Before-Travel

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The European Medicines Agency Committee for medicinal products for human use (CHMP) releases a draft agenda for their meeting on June 21, 2021. This CHMP meeting is led by Harald Enzmann and will run until June 24th.

This agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Therefore, some of the information in this agenda is considered commercially confidential or sensitive and therefore not disclosed.

Regarding intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalized, and the start of referrals will also be available.

As of June 21, 2021, the CHMP has and continues to review several COVID-19 vaccines for clinical benefit-risk assumptions.

During the May 2021 meeting, eight new medicines were recommended for approval, including one gene therapy medicine.

Vaccine Treats:

COVID-19

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Live Blog Update Author:

Don Hackett

Location Tags:

Europe

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The US Centers for Disease Control and Prevention (CDC) issued a Level 4 Travel Health Notice for Sweden due to the COVID-19 pandemic. This CDC Travel Alert indicates a very high level of COVID-19 transmission in the country.

Furthermore, there are restrictions in place affecting U.S. citizen's entry into Sweden.

On June 17, 2021, the CDC said 'your risk of contracting COVID-19 and developing severe symptoms may be lower if you are fully vaccinated with a U.S. FDA Authorized vaccine. Therefore, before planning any international travel, please review the CDC’s specific recommendations for fully vaccinated and unvaccinated travelers.

As of June 1, 2021, foreign nationals aged 18 or over must present a negative Covid-19 test result certificate at Sweden's border to be permitted entry. The test must have been conducted a maximum of 48 hours before arrival.

However, travelers from the Nordic countries (Denmark, Finland, Iceland, and Norway) do not have to present a negative covid test.

Visit the U.S. Embassy COVID-19 page for more information on COVID-19 and related restrictions and conditions in Sweden.

The free Smart Traveler Enrollment Program offers up-to-date safety and security information during emergencies when traveling abroad, says the US Department of State.

Vaccine Treats:

COVID-19

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Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Sweden

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The US Centers for Disease Control and Prevention (CDC) issued a Level 4 Travel Alert on June 21, 2021, saying 'avoid traveling to Malaysia due to the ongoing COVID-19 outbreak.

The CDC says, 'Because of the current situation in Malaysia, even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants. Therefore, if you must travel to Malaysia, make sure you are fully vaccinated before travel.'

Since June 15, 2021, Malaysia has implemented Phase One of a Full Movement Control Order. As a result, individuals who need to cross-district or state borders, including for travel to the Kuala Lumpur International Airport, must obtain police or employer authorization before traveling.

On June 8, 2021, the U.S. Embassy in Kuala Lumpur delivered an additional donation of COVID-19 relief assistance to help Malaysia fight against the pandemic. The supplies were delivered to the National Disaster Management Agency (NADMA) in Putrajaya and included information technology equipment that NADMA will use to manage COVID-19 response operations in Malaysia.

Recently the CDC issued a separate Travel Alert for Asia, which includes Malaysia, that stated 'everyone should be fully vaccinated against poliovirus according to schedule.'

Additionally, the CDC suggests various routine and travel vaccines prior to visiting Malaysia.

Vaccine Treats:

COVID-19

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Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Malaysia

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Vir Biotechnology, Inc. and GlaxoSmithKline plc announced final, confirmatory results from the Phase 3 COMET-ICE trial demonstrating that sotrovimab, an investigational SARS-CoV-2 monoclonal antibody, significantly reduced the risk of hospitalization or death among high-risk adult outpatients with mild-to-moderate COVID-19.

Additionally, the companies confirmed that the U.S. National Institutes of Health (NIH) updated its COVID-19 treatment guidelines to recommend sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.

The primary efficacy analysis of all 1,057 patients in the COMET-ICE trial demonstrated a 79% reduction in hospitalization for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial.

The number of patients in the trial who were hospitalized for >24 hours for acute management of any illness or death from any cause at Day 29 was six patients in the sotrovimab arm (1%), versus 30 patients in the placebo arm (6%).

George Scangos, Ph.D., CEO of Vir, said in a press statement issued on June 21, 2021, “We are pleased that the profound interim efficacy from the COMET-ICE trial has now been validated by the full study population. These results, combined with the growing number of pending global authorizations, as well as the recent recommendation by the NIH COVID-19 Treatment Guidelines Panel, support our confidence in the potential role of sotrovimab in the fight against this pandemic.”

Based in San Francisco, CA, Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

Vaccine Treats:

SARS-CoV-2

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Live Blog Update Author:

Karen McClorey Hackett

Reviewer:

Robert Carlson, MD

Location Tags:

San Francisco

young boy happy standing by colored tires

Guinea Ebola Outbreak Declared Over

Merck Ervebo is a recombinant, replication-competent Ebola vaccine

June 20, 2021

Fact checked by Robert Carlson, MD

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IAVI announced on June 15, 2021, it received an award of ~US$27 million from the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Coalition for Epidemic Preparedness Innovations (CEPI) to conduct a Phase IIb clinical trial of a novel vaccine candidate to prevent Lassa fever disease.

An acute viral illness endemic to many parts of West Africa, Lassa fever causes significant annual outbreaks of disease. Lassa fever is endemic in West Africa, including Sierra Leone, Liberia, Guinea, and Nigeria, says the U.S. CDC.

As a result, there are an estimated 5,000 related deaths each year. Despite this disease burden, which is believed to be significantly underestimated, no vaccine for Lassa fever is currently available, says IAVI.

IAVI’s Lassa fever vaccine candidate, rVSV∆G-LASV-GPC, uses a recombinant vesicular stomatitis virus (rVSV) vector — the same rVSV platform used for Merck's rVSV-vectored Ebola Zaire vaccine, ERVEBO®, which is now registered for use in eight African countries.

rVSV∆G-LASV-GPC provided high-level protection from Lassa fever in previously conducted animal studies. A phase 1 study is evaluating the Safety and Immunogenicity of the rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health.

IAVI, EDCTP, and CEPI are united in their commitment to global equitable access to vaccines, with rVSV∆G-LASV-GPC to be accessible to all populations that need the candidate vaccine, should it be found safe and effective in clinical testing.

Vaccine Treats:

Lassa Fever

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Live Blog Update Author:

Don Hackett

Location Tags:

Europe

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On June 16, 2021, the U.S. CDC lowered its Travel Alert for cruise trips to Level 3 status. However, the CDC recommends people who are not fully vaccinated with a COVID-19 vaccine avoid any travel on cruise ships, including river cruises, because the risk of COVID-19 on cruise ships is high.

The CDC says 'cruise passengers who are not fully vaccinated against COVID-19 are at increased risk since the virus spreads person-to-person, and outbreaks of COVID-19 have been reported on cruise ships because of their congregate settings where COVID-19 spreads easily.'

Furthermore, 'people who decide to go on a cruise should get tested 1–3 days before their trip and 3–5 days after their trip.'

'In addition to testing, passengers who are not fully vaccinated should self-quarantine for seven days after cruise travel, even if they test negative. If they do not get tested, they should self-quarantine for 10 days after cruise travel,' says the CDC.

Vaccine Treats:

COVID-19

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Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

United States of America

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The Global Polio Eradication Initiative reported as of June 15, 2021; seven countries reported polio cases involving circulating vaccine-derived poliovirus type 2 (cVDPV2).

The summary of new polio this week include:

Afghanistan: one cVDPV2 case
Burkina Faso: two cVDPV2 cases
Benin: one cVDPV2 case
Congo: one cVDPV2 positive environmental sample
Côte d’Ivoire: one cVDPV2 positive environmental sample
DR Congo: one cVDPV2 case
Ethiopia: six cVDPV2 cases
Niger: one cVDPV2 case and one cVDPV2 positive environmental sample
Senegal: five cVDPV2 cases

The U.S. CDC maintained its Level 2 Travel Alerts for Africa and Asia this week.

The CDC continues to suggest 'before travel to any high-risk destination, adults who previously completed the full, routine polio vaccine series receive a single, lifetime booster dose of polio vaccine. And, everyone should be fully vaccinated against poliovirus according to the regular schedule.'

Since 2000, the inactivated polio vaccine is most often given in the USA, says the CDC.

Vaccine Treats:

Polio

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Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Africa

Vaccine:

IPOL Poliovirus Vaccine

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The Pan American Health Organization (PAHO) reported that on June 14, 2021, influenza B detections accounted for most of the very low numbers of detections reported globally. Despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.

In the Northern Hemisphere's temperate zone, influenza activity remained below baseline, though detections of influenza B/Victoria lineage slightly increased.

In the temperate zone of the Southern Hemisphere, influenza activity remained at an inter-seasonal level.

And in tropical Africa, influenza detections were reported in some countries in Western and Middle Africa. While in South East Asia, no influenza detections were reported.

The information presented in this Week #21 update is based on data provided by the Ministries of Health and National Influenza Centers of Member States to the PAHO or from updates on the Member States' Ministry of Health web pages.

The most common flu shot in the Northern Hemisphere are quadrivalent vaccines that protect people against four viruses: influenza A (H1N1) virus, influenza A (H3N2) virus, and two influenza B viruses, said the U.S. CDC.

Vaccine Treats:

Influenza

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Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

North America

BVRS-GamVac-Combi MERS Vaccine

BVRS-GamVac-Combi MERS Vaccine is a heterologous adenoviral-based vaccine. "BVRS-GamVac-Combi" is a combined vector vaccine to prevent Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration.

Adenoviruses have been used in gene therapy and have also been researched for use in vaccines for decades. An adenovirus can be used as a vector, or carrier, to deliver a gene to cells with instructions to make a protein required for the body to function properly. Think of the adenovirus vector as an envelope with a message inside.

Headquartered in Moscow, Russia, the Gamaleya Research Institute of Epidemiology and Microbiology, previously known as the N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology, is a Russian medical research institute. The center was founded in 1891 as a private laboratory. Since 1949 it bears the name of Nikolai Gamaleya, a pioneer in Russian microbiology studies.

BVRS-GamVac-Combi Indication

BVRS-GamVac-Combi MERS Vaccine is indicated to prevent Middle East Respiratory Syndrome (MERS). MERS-CoV is another form of coronavirus and causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. Human-to-human transmission is amplified among household contacts and in healthcare settings, stated the ECDC. And, scientific evidence suggests that people are infected through direct or indirect contact with infected dromedary camels.

MERS-CoV was first reported in the Kingdom of Saudi Arabia in 2012. The outbreak of MERS-CoV in South Korea during 2015 involved 186 cases, including 38 fatalities.

From January 2021 to May 31, 2021, nine MERS-CoV cases have been reported in Saudi Arabia (8) and the United Arab Emirates (1), including five deaths.

BVRS-GamVac-Combi Dosage

Phase 1 study - the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose.

BVRS-GamVac-Combi MERS News 2020 - 2022

January 14, 2021 - Phase 1 study update: The study aims to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

December 20, 2020 - The Journal of Biomedical Science published a study: Coronavirus vaccine development: from SARS and MERS to COVID-19.