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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #21.10

COVID-19 Vaccines. Update #7

On Tuesday April 13, the U.S. FDA and the Centers for Disease Control and Prevention recommended that the distribution of the Johnson & Johnson/Janssen COVID-19 vaccine be temporarily paused amid investigations into blood clotting among a small number of recipients. According to the agencies, the potential side effect has been reported among six people, within the nearly 7 million people who have received the single-dose vaccine. These unusual blood clotting were observed in women aged 18 to 48 years of age.

The blood clotting were very similar to the 222 cases observed in subjects who had received the AstraZeneca/Oxford vaccine and obliged the Anglo-Swedish company to change its labelling and indicate that blood clot could be a possible side effect of the vaccine.

The observed blood clotting are unusual, as far as they do not resemble well known peripheral thrombosis, but appear as severe thrombotic complications at unusual sites: cerebral venous thrombosis and splanchnic-vein thrombosis, one to two weeks after vaccination with the AstraZeneca/Oxford COVOD-19 vaccine. In a New England Journal of Medicine article of April 9, Professor Andreas Greinacher and a team of researchers in Germany, Austria and Canada are proposing a plausible hypothesis of the deadly blood clots. “The clinical picture of moderate-to-severe thrombocytopenia and thrombotic complications after vaccination against SARS-CoV-2 with ChAdOx1 nCov-19 suggests a disorder that clinically resembles severe heparin-induced thrombocytopenia, a well-known prothrombotic disorder caused by platelet-activating antibodies that recognises multimolecular complexes between cationic PF4 and anionic heparin.”

It is not unreasonable to consider that the recent blood clots observed with the J&J vaccine are triggered by the same biological mechanism as the ones seen in the AstraZeneca vaccine. Both vaccines as well as the Spoutnik V vaccine are using an adenovirus technology. Several epidemiologists are seriously considering that the blood clotting events are triggered by the adenovirus vector, since none of this side effect has been reported in the more than 200 million subjects who have received the Pfizer/BioNTech vaccine, based on the mRNA technology.

J&J has already announced that the rollout of is vaccine will be delayed in Europe. On the contrary Pfizer and BioNTech have confirmed that they have ramped up production of their COMIRNATY vaccine allowing the delivery of 2.5 billion doses in total by the end of 2021. Both companies will raise their vaccine deliveries to the European Union by 50 million this quarter. In a recent interview Professor Ugun Sahin, BioNTech CEO, explained that his company is “looking at whether or not a third booster shot 6-12 months after the second dose of the vaccine can increase immunity”. He also mentioned a study showing that COMIRNATY is 100% effective at preventing disease in adolescents ages 12-15 years old and that a study in even younger children is still ongoing.

Moderna revealed updated data from the Phase 3 COVE study showing that its vaccine efficacy against the severe form of the disease was still at 90% efficacy nearly six months after the second dose of the vaccine. The pre-clinical studies with its variant-specific booster vaccine candidates (mRNA-1273.351 and mRNA-1273.211) have raised neutralizing titters against newly detected coronavirus variants. Moderna also confirmed ongoing studies targeting adolescents.

Led by the University of Oxford in a mix-and match study, the U.K is assessing the value of vaccine combination therapies. Initially the study was designed to assess the vaccines from AstraZeneca/Oxford and BioNTech/Pfizer. Moderna and Novavax have confirmed that the ongoing U.K. study is also exploring the effect of the combination of their vaccines.

Novavax had previously reported that its own COVID-19 vaccine was 96% efficacious in the normal setting and 86% efficacious against the B.1.1.7 virus better known as  “British” variant.

Takeda Pharmaceuticals has stopped the development of COVID-19 therapy which uses antibodies from recovered COVID-19 patients, following the treatment’s failure to show efficacy in a phase 3 study led by the National Institute of Allergy and Infectious Diseases enrolling nearly 600 adult participants.

Paris, April 14, 2021

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