Coronavirus Breaking News

New Brunswick, NJ - based Johnson & Johnson (J&J) announced that vaccinations with the Company’s (Janssen) COVID-19 single-shot vaccine would resume for all adults aged 18 years and older in the USA following a decision from the CDC and FDA late on April 23, 2021.

This decision to rescind an eleven-day 'Pause' was based on a recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.

The experimental J&J COVID-19 Vaccine, developed by the Janssen Pharmaceutical Companies of J&J, received emergency authorization from the FDA on February 27, 2021, to prevent COVID-19 in individuals 18 years of age and older. The FDA has not approved this vaccine.

“We believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere. We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively,” said Paul Stoffels, Chief Scientific Officer of J&J, in a press statement.

J&J has updated the Fact Sheets for Healthcare Providers Administering Vaccine and Recipients and Caregivers for the Company’s COVID-19 vaccine to include information about the diagnosis and treatment of thrombosis with thrombocytopenia.

The CDC, FDA, and American Society of Hematology have made information about the proper recognition and management of this medical condition and the unique treatment required for this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop a severe headache, chest pain, swelling in the leg, abdominal pain, tiny blood spots under the skin, or excessive bruising within two weeks after vaccination should immediately contact their health care provider.

The Pharmaceutical Companies of Johnson & Johnson focuses on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com.

The European Medicines Agency (EMA) announced on April 23, 2021, an increase in vaccine manufacturing capacity and supply for mRNA COVID-19 vaccines produced by BioNTech - Pfizer and Moderna.

The EMA approved an increase in batch size and associated process scale-up at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The Agency’s Committee for Human Medicines (CHMP) recommendation is expected to have a significant impact on the supply of the COVID-19 vaccine (Comirnaty) developed by BioNTech and Pfizer in the European Union.

The CHMP also recommended the approval of a new filling line at Moderna’s vaccine finished product manufacturing site for the EU in Rovi, Spain. The new line will enable an increase in finished product fill activities to synchronize with the active substance scale-up process at the active substance manufacturing site (Lonza, Visp) approved last month.

The mRNA vaccine changes will be included in the publicly available information on EMA’s website.

Researchers with the US Centers for Disease Control and Prevention (CDC) or the Food and Drug Administration published a study in the NEJM on April 21, 2021 that concluded 'Preliminary findings did not show obvious safety signals among pregnant females who received an mRNA COVID-19 vaccine, such as the Pfizer-BioNTech or Moderna vaccines.

Among 3,958 participants enrolled in the US V-Safe Pregnancy Registry, 827 females had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth.

Most of these women had the mRNA vaccination in the third trimester.

Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%).

However, no neonatal deaths were reported.

Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against COVID-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women conducted before the COVID-19 pandemic.

'Longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes,' wrote these researchers. The study authors are U.S. government employees or contractors and do not have any material conflicts of interest.

As of March 18, 2021, the CDC says, 'Getting vaccinated is a personal choice. Based on how these vaccines work in the body, experts believe they are unlikely to pose a specific risk for pregnant women. Any of the currently authorized COVID-19 vaccines can be offered to women who are pregnant or breastfeeding.'

'If you have questions about getting vaccinated, a conversation with your healthcare provider might help but is not required.'

The Moderna and Pfizer-BioNTech experimental mRNA vaccines do not contain the live virus that causes COVID-19 and, therefore, cannot give someone COVID-19, says the CDC.

Massachusetts-based Moderna, Inc. announced a new supply agreement with the State of Israel for 2022. Under the terms of this agreement confirmed on April 20, 2021, Israel retains an option to purchase doses of one of Moderna’s variant-specific vaccine candidates subject to regulatory approval.

Today’s announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine Moderna, which the Israeli Ministry of Health authorized on January 4, 2021.

Stéphane Bancel, CEO of Moderna, stated in a press release, “Recent preclinical results have shown that our variant-specific booster candidates were effective against COVID-19 variants of concerns, and we hope to continue to see positive results from the clinical studies.”

The experimental COVID-19 Vaccine Moderna is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike protein, which was co-developed by Moderna and investigators from the US National Institute of Allergy and Infectious Diseases’ Vaccine Research Center.

Moderna's COVID-19 vaccine received an Emergency Authorization and has not been Approved by the U.S. FDA.

Cambridge-based Moderna has transformed into an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and unprecedented speed.

The Moscow-based Russian Direct Investment Fund (RDIF) and Laboratorios Richmond SACIF pharmaceutical company of Argentina today announced the production of the first batch of the Sputnik V vaccine in Argentina.

Argentina has become the first country in Latin America to register Sputnik V officially.

Full-scale production of the vaccine is anticipated for June 2021. Sputnik V vaccine produced in Argentina could be exported to Central and Latin America countries at a later stage.

Alberto Fernández, President of Argentina, commented in an RDIF press release issued on April 20, 2021, “We are very excited about the possibility of producing Sputnik V in Argentina, a vaccine with which we are already protecting a large part of our population with excellent results. It will be a great opportunity to advance in the fight against the pandemic not only in Argentina but also in Latin America.”

Marcelo Figueiras, President of Richmond Laboratories, added, “We celebrate this recognition that we will reward with work, commitment, and professionalism, to facilitate the availability of the vaccine in the shortest possible time for Argentina and the entire Latin American region.”

RDIF is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors.

Researchers at the University of Oxford in England announced on April 19, 2021, they have launched a COVID-19 vaccine human challenge trial to look at what kind of immune response can stop people from becoming re-infected.

These researchers also want to see how the immune system reacts the second time around.

A human challenge trial in medical research is a carefully controlled study that involves purposefully infecting a subject with a pathogen or bug to study the effects of that infection, says the Oxford press statement.

Any participants who develop any symptoms will be given medical treatment with the Regeneron monoclonal antibody treatment. They will only be discharged from the quarantine unit when they are no longer infected and not at risk of infecting others. The full length of the study will be 12 months, including a minimum of eight follow-up appointments after discharge. Participation in the study is completely voluntary.

The virus used in the study will be the original strain from Wuhan, China.

The study participants will be quarantined in a specially designed hospital suite for a minimum of 17 days under the care of the research team. They will undergo numerous medical tests, including CT scans of the lungs and MRI scans of the heart. The risks to participants will be minimized by ensuring that those who take part are completely fit and well and have completely recovered from their first infection with COVID.

Helen McShane, Professor of Vaccinology at the Department of Paediatrics, University of Oxford and Chief Investigator on the study, said in a press release, ‘Challenge studies tell us things that other studies cannot because, unlike natural infection, they are tightly controlled."

"When we re-infect these participants, we will know exactly how their immune system has reacted to the first COVID infection, exactly when the second infection occurs, and exactly how much virus they got. As well as enhancing our basic understanding, this may help us to design tests that can accurately predict whether people are protected."

"In phase two, we will explore two different things. First, we will define the baseline immune response in the volunteers very carefully before we infect them. We will then infect them with the dose of virus chosen from the first study and measure how much virus we can detect after infection. We will then be able to understand what kind of immune responses protect against re-infection."

"Second, we will measure the immune response at several time points after infection to understand what the virus generates immune response.

"A challenge study allows us to make these measurements very precisely because we know exactly when someone is infected. The information from this work will allow us to design better vaccines and treatments and understand if people are protected after having COVID and for how long."

The Wellcome Trust funds the study. Shobana Balasingam, Vaccines Senior Research Advisor at Wellcome.

New York-based Pfizer Inc. and BioNTech SE announced they have agreed to supply an additional 100 million vaccine doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states later in 2021.

Comirnaty (Pfizer-BioNTech COVID-19 vaccine) was granted conditional marketing authorization by the European Medicines Agency to prevent COVID-19 in people from 16 years of age.

This announcement results from the European Commission’s decision to exercise an option under its expanded Advanced Purchase Agreement signed on February 17, 2021. This new vaccine order brings the total number of Pfizer-BioNTech doses to be delivered to the EU to 600 million.

This vaccine order will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe, stated the companies.

“We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe,” commented Albert Bourla, Chairman and CEO, Pfizer, in a related press statement. “To date, we have met all of our supply commitments to the EC and we plan to deliver 250 million doses to the European Union in Q2'21, a four-fold increase on Q1’s agreed quantity.”

Located in Mainz, Germany, Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.