Vaccine News

The Republic of the Maldives announced on May 1, 2021, the Health Protection Agency (HPA) clarified the COVID-19 related requirements for visitors to visit the island nation.

To ensure the safety of all, HPA has made it a mandatory requirement for all tourists, including those who have completed the prescribed dose(s) of a COVID-19 vaccine, to present a negative result for a Nucleic Acid Test (PCR test) for COVID-19 on arrival effective May 3, 2021.

The sample for said PCR test must be taken not more than 96 hours before the scheduled time of departure from the first port of embarkation en route to the Maldives.

The Maldives comprises about 1100 islands in the Indian Ocean that spans across the equator. Only 200 of the islands are inhabited, and a select few on each of the atolls are resorts, and some of the islands are used for industry and agriculture.

The beauty of the Maldives is not only above the water, says Visit Maldives.com.

The Maldives is home to about five percent of the planet’s reefs that come with an explosion of color contributed by soft and hard corals that form them. The reefs are home to a thousand species of fish. Lured by the rich nutrients that flow in with the currents, large pelagic fishes such as manta rays and whale sharks also make the Maldives their home.

As the debate of when to open up the cruise industry as the COVID-19 pandemic subsides in Florida, media reporting indicates it may become a content between whose legal authority is greater, a US state or the Federal government.

The AP reported on May 7, 2021, Miami-based Norwegian Cruise Line (NCL) Holdings is threatening to keep its ships out of Florida after Governor Ron DeSantis signed Executive Order #21-102 on April 3, 2021, banning local businesses from requiring customers in Florida to show proof of COVID-19 vaccination.

NCL says the new Florida law is at odds with US Centers for Disease Control and Prevention (CDC) guidelines, which would let cruise ships operate in U.S. waters if nearly all passengers and crew members are vaccinated. “It is a classic state-versus-federal-government issue,” said Norwegian’s CEO, Frank Del Rio. “Lawyers believe that federal law applies and not state law, but I’m not a lawyer. And we hope that this doesn’t become a legal football or a political football.”

On April 28, 2021, NCL confirmed, 'We are committed to taking all appropriate actions to combat the spread of COVID-19 and are working closely and in partnership with local, state, federal, and global agencies. Our teams are working around the clock to do what is right for our guests and travel partners and keep them informed of the latest happenings.'

In conjunction with our second return to service announcement, we have extended our voluntary temporary suspension for Pride of America and Norwegian Bliss through July 2021 as well as various September and October voyages across the fleet.'

And 'Norwegian Joy, Norwegian Jade, Norwegian Getaway, Norwegian Epic, and Norwegian Gem now boast new homeports in Greece, Spain, Italy, and the Caribbean for six new itineraries.'

Since March 2020, the CDC has barred cruise ships from sailing in U.S. waters or stopping at U.S. ports.

However, some good news was announced on May 5, 2021.

The CDC released guidance for cruise ships to undertake simulated voyages with volunteer passengers as part of its COVID-19 Conditional Sailing Certificate (CSO) application. In addition, this release includes the COVID-19 Conditional Sailing Certificate application, which is the final step before restricted passenger voyages.

The CDC released the CSO in October 2020 to prevent the further spread of COVID-19 on cruise ships, from cruise ships into communities, and to protect public health and safety. 

GlaxoSmithKline plc (GSK) and California-based Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) had started a rolling review of data on an investigational compound known as Sotrovimab (VIR-7831), a dual-action SARS-CoV-2 monoclonal antibody.

The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1, indicating that the epitope is highly conserved and less likely to mutate over time. Sotrovimab, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

The EMA will evaluate all data on Sotrovimab, including evidence from clinical trials, as they become available.

The EMA's decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE clinical trial, which evaluated Sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. The interim analysis demonstrated an 85% reduction in hospitalizations over 24 hours or deaths in those receiving Sotrovimab.

The companies submitted an Emergency Use Authorization application for Sotrovimab to the US Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada. Sotrovimab has not been granted a marketing authorization anywhere globally.

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. For further information, please visit www.gsk.com/about-us. 

The U.S. Food and Drug Administration issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic.

Its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.

“Like most organizations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance, and compliance activities were significantly impacted,” commented Acting FDA Commissioner Janet Woodcock, M.D., in an FDA press statement.

“The FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we’ve faced in these areas over the past year, as well as our plan moving forward."

"We want to assure the American public that we have used a variety of tools to oversee the regulated industry and ensure that Americans continue to have access to safe food and high-quality FDA-regulated products," concluded Dr. Woodcock.

Based in Maryland, the FDA will continue to leverage and maximize every available tool and resource to meet its inspectional responsibilities while achieving optimal public health outcomes.

Urgent international support is needed to prevent a worsening humanitarian catastrophe in countries across South Asia, announced the International Federation of Red Cross and Red Crescent Societies (IFRC) on May 5, 2021. 

In Nepal, many hospitals are full and overflowing with COVID-19 patients.

Southern towns near the Indian border are unable to cope with the growing number of people needing medical treatment. Nepal is recording 57 times more COVID-19 cases than this time last month. 

Across Nepal, 44% of tests recently returned positive results according to government authorities, indicating many thousands of infections are undiagnosed.

Nepal Red Cross Chairperson, Dr. Netra Prasad Timsina, said in an IFRC statement, “What is happening in India right now is a horrifying preview of Nepal’s future if we cannot contain this latest COVID surge that is claiming more lives by the minute."

“Every effort is being made to save lives right now across Nepal with increased medical treatment. Nepal Red Cross volunteer health teams are also reducing record infections by helping with testing, vaccinations, handwashing, mask-wearing, and isolating infected people." 

“It is beyond distressing to see that people cannot say goodbye to their loved ones as cremations are taking place at record levels due to these new COVID variants, which are striking down people of all ages in Nepal.” 

All South Asian countries have started vaccinating people who are most at-risk, yet in Nepal, only 1% of the population has received two doses of a COVID-19 vaccine, as of May 5th.

The IFRC's Asia Pacific Director Alexander Matheou added, "This coronavirus has no respect for borders. Nepal urgently needs support, to save more lives and treat people who are suffering. We will not succeed in overcoming this terrible disease until vaccines are available to protect everyone, regardless of nationality or income.”

Cambridge-based Moderna, Inc. (Nasdaq: MRNA) announced financial results and provided business updates for the first quarter of 2021, and highlighted pipeline progress. Total revenue was $1.9 billion for the three months ended March 31, 2021, compared to $8 million for the same period in 2020. Net income was $1.2 billion.

A total of 102 million experimental Moderna COVID-19 vaccine doses were produced, generating a significant amount of the Company's revenue.

The Company increased its 2021 supply forecast to between 800 million and 1 billion vaccine doses, And Moderna confirmed it is making investments to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022.

On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization enabling the mRNA COVID-19 Vaccine Moderna to be distributed in the USA for use in individuals 18 years of age and older. 

Furthermore, Moderna plans to initiate a rolling submission to the FDA for a Biologics License Application in the U.S. during May'21. The FDA is the regulatory authority with oversight of the safety, effectiveness, and quality of vaccines used in the USA.

“In the first quarter, the Moderna team delivered on its supply commitments to help protect more than 100 million people. This accomplishment translated into our first profitable quarter in the company’s history, after 10 years of scientific innovation and several billion dollars invested to make our mRNA platform a reality,” commented Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 5, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 7487119.

The US Centers for Disease Control and Prevention (CDC) issued a Level 2 Travel Alert on May 3, 2021, confirming vaccine-derived polio outbreaks in many countries in Africa. 

The CDC's 'Practice Enhanced Precaution' Alert recommends that all travelers to these African countries be vaccinated fully against polio.

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

Poliovirus outbreaks have been reported in the following African countries (map). And, before traveling to these countries, adults who completed their routine polio vaccine series as children should receive a single, lifetime adult booster dose of polio vaccine.

Although wild-type polio was eradicated in Africa in 2020, vaccine-derived poliovirus can cause outbreaks in low vaccination areas. The Polio vaccine protects against both wild-type and vaccine-derived poliovirus infection. 

To learn more about vaccine-derived polio, visit this CDC webpage.