Sharing is caring!


More than 1.7 million COVID-19 vaccines arrive in the Democratic Republic of Congo

More than 1.7 million doses of COVID-19 vaccines have arrived in Kinshasa, the capital of the DRC. They were shipped to the country through COVAX, an alliance comprising the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, and the World Health Organisation (WHO) working in partnership with UNICEF as key implementing partner.

The arrival of the vaccines is an historic step towards ensuring equitable distribution of COVID-19 vaccines worldwide. Their delivery is part of the largest vaccine procurement and supply operation in history. The vaccines in the DRC are part of a first wave of supplies that will continue over the next few weeks.

Medical authorities have decided to use the Astra Zeneca vaccine because it meets the DRC’s existing storage conditions (between 2° and 8°C). A plan for the deployment of the COVID-19 vaccines across the country is being finalised.

The distribution is based on epidemiological data and WHO guidelines. The initial aim is to vaccinate 20 per cent of the population, including health workers (who represent 1 per cent of the population), people aged over 55 (6 per cent of the population) and people suffering from serious health conditions such as kidney disease, high blood pressure or diabetes (13 per cent of the population).

« The DRC is among the first countries in Africa to receive these vaccines, » said Health Minister Dr Eteni Longondo. The vaccinations will enable us to protect and save lives. We must encourage the target population to be vaccinated. »

The government submitted its request to the international community for COVID-19 vaccines in December. The Ministry of Health, through its Expanded Programme on Immunisation (EPI), will carry out the vaccinations at fixed sites throughout the country.

“This is an important moment for DRC, the African continent and COVAX – we are moving closer to our common goal of ensuring equitable access to COVID-19 vaccines, ” said Emmanuel Bor, Gavi Country Manager. “Gavi is delighted to see the ambition of the COVAX Facility come to fruition with this first wave of deliveries that will protect the most vulnerable, including health workers on the front line in the fight against this pandemic in DRC. “

UNICEF is helping with the logistics of delivering the vaccines including the transport of injection materials and protection materials. The UN children’s agency will also ensure the quality and security of the cold chain and vaccine storage.

“The arrival of these vaccine doses in the DRC, which correspond to the first allocation of 6 million doses, is very encouraging news for beneficiaries who want to be vaccinated in complete safety, ” said WHO Press Officer Dr Amédée Prosper Djiguimdé. “We need to work together to prioritise those most at risk of serious illness and death in the country in order to deliver on the promise of equitable access.”

Gavi, with support from the WHO, UNICEF, and the EPI will train health personnel on the logistical aspects of providing vaccinations while raising awareness among the Congolese population before the actual vaccination process begins to operate.

The UK and American governments have meanwhile expressed their support for the vaccination scheme and their pride in supporting it financially.

“The UK is delighted that the DRC is among the first countries in the world to receive Covid-19 vaccines through the Covax initiative,” said Juliette John, Director of British Cooperation. “With a commitment of $750 million, the UK is one of the founders and main donors of COVAX. Together with our international partners, we are working with the Government of the DRC to implement the national COVID-19 vaccination programme, in particular access to health vaccines for health workers and the most vulnerable.”

U.S. Ambassador to the DRC Mike Hammer gave an equally warm response. “We welcome the arrival of vaccines against Covid-19 in the DRC,” he said. “The U.S. is working with other partners around the world to stop the devastating effects of this on both public health and the economy. As part of this commitment, President Biden announced a US$4 billion contribution to support the international COVAX initiative and the United States is proud to work alongside the DRC government and other partners to bring this vaccine of vital importance to the Congolese people.”

The European Union and its member countries are also supporting governments and partners in their efforts to prepare for this moment. They have been particularly active in working with some of the world’s poorest countries to ensure global and equitable access to vaccines against COVID-19.

“Routine vaccination will continue to take place every day in health centres so that we can continue protecting children against vaccine-preventable diseases,” said Edouard Beigbeder, UNICEF Representative in DRC.

The first phase of vaccine introduction for the year 2021 will target the four provinces of the DRC most affected by the pandemic: Kinshasa, North Kivu, Central Kongo and Haut-Katanga.

(Source: UNICEF, 2021)


Baxter BioPharma Solutions and Moderna Announce Agreement for Fill/Finish Manufacturing of the Moderna COVID-19 Vaccine in the U.S.

Baxter International Inc. (NYSE: BAX), a global leader in sterile medication production and delivery, and Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that they have entered into an agreement for Baxter BioPharma Solutions to provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of the Moderna COVID-19 Vaccine in 2021. Baxter’s BioPharma Solutions business is a premier contract manufacturing organization that specializes in parenteral (injectable) pharmaceuticals, including vaccines.

“We have seen a remarkable demonstration of scientific and health care expertise in the effort to develop vaccines for COVID-19,” said Marie Keeley, vice president, Baxter BioPharma Solutions. “Baxter is honored to provide our deep expertise in vaccine manufacturing to help partners like Moderna bolster the supply of their vaccine.”

The manufacturing of the Moderna COVID-19 vaccine will take place at the BioPharma Solutions fill/finish sterile manufacturing facilities located in Bloomington, Ind. The site has capabilities and expertise in parenteral delivery systems and clinical and commercial vaccine manufacturing, including preventive and seasonal vaccines for global markets. In addition, Bloomington offers a range of production and commercialization services, including clinical development, formulation, packaging and commercial launch capabilities. Baxter BioPharma Solutions has operated in Bloomington for approximately 20 years and employs more than 700 individuals on its 600,000 square foot campus.

“We welcome the opportunity to work with Baxter BioPharma Solutions on fill/finish manufacturing for the Moderna COVID-19 Vaccine in the U.S.,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. “This additional production will help us continue to scale up our manufacturing capacity in the United States.”

Additional details of the agreement were not disclosed.

(Source: Moderna Therapeutics, 2021)


VALNEVA AND PFIZER ANNOUNCE INITIATION OF PHASE 2 STUDY FOR LYME DISEASE VACCINE CANDIDATE

Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. (NYSE: PFE) today announced initiation of study VLA15-221. The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies.

As announced in December 20201, VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It will be the first VLA15 study to include a pediatric population (aged 5-17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6).

“We are excited to be part of the Lyme disease vaccine development program with Valneva. We hope this Phase 2 trial, with a simplified schedule, will provide evidence that the investigational vaccine can be used in populations that are at risk of contracting Lyme disease, potentially including children age five years and older,” said Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva commented, “This trial initiation marks an important step in the development of VLA15 toward a potential licensure. Including a pediatric population in Phase 2 means we could, if successful, add this population to the Phase 3 research program, to potentially offer a vaccine for Lyme disease that may help prevent disease in both adults and children, if approved. We are pleased that, together with our partner Pfizer, we have decided to pursue this development while preparing for a potential Phase 3 start.”

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA152. Under the terms of the agreement, first subject, first dose in this study will trigger a milestone payment of $10 million from Pfizer to Valneva.

(Source: Pfizer, 2021)