Medication orders for poorer countries show that the WHO apparently relies primarily on monoclonal antibodies and steroids in the fight against Covid-19. Remdesivir, which is already used worldwide for treatment, is not on the shopping list. In the fight against Corona in poorer countries, the World Health Organization is primarily relying on the experimental treatment with monoclonal antibodies and the use of steroids. This emerges from the draft of a WHO document that the Reuters news agency had insight into. The globally approved remdesivir, on the other hand, is not on the list of preferred WHO drugs. Reuters advises that the draft could still be changed, but that it was about to be published.
7.4 billion for worldwide use
The program is the so-called Access to Covid-19 Tools Accelerator (ACT Accelerator), which the WHO started in April in order to enable global cooperation in the fight against the corona pandemic in the development and manufacture of vaccines and drugs and their fair distribution. The program is jointly managed by the Wellcome Trust charity and Unitaid, a WHO health partnership. At an international donor conference, more than 40 countries, UN bodies and non-profit foundations pledged to provide a total of around 7.4 billion euros for the research and development of coronavirus solutions. The document sets out for the first time how this money is to be used. Accordingly, the two primary goals are to secure monoclonal antibodies in a narrow market and to force the distribution of the cheap steroid dexamethasone.
Monoclonal Antibodies Before Vaccine?
According to Reuters, more than half of the money will be used to purchase and distribute monoclonal antibodies. According to the document, the WHO believes that such drugs could change the situation significantly. However, they have so far been tight.
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Monoclonal antibodies are so named because they come from a single B‑cell line. The genetic material of this B‑cell is cloned so that — for example in cell cultures — identical antibodies can be produced. Like the original, these protein molecules adhere to intruders like Sars-CoV‑2 and thus prevent them from docking and penetrating cells. They also mark the attackers so they can identify and fight other parts of the immune system. No antibody drug against Covid-10 has yet been approved, but experts such as US immunologist Anthony Fauci expect them to be used before vaccines. In this respect, the WHO’s commitment to monoclonal antibodies makes sense. But their success is not certain.
Antibodies are probably only preventive
Among other things, the US pharmaceutical company Eli Lilly recently stopped its ongoing study with test subjects. According to the company’s statement, its active ingredient bamlanivimab had shown little or no effect in hospitalized patients. The US competitor Regeneron had a similar experience with its drug REGN-COV2. Based on the recommendation of an independent safety review, the group initially discontinued studies with patients who require ventilation. However, other hospitalized patients continue to receive the drug. The results are no surprise to experts. “Mechanistically speaking, the administration of neutralizing antibodies only makes sense in the early phase of the infection, when the virus is still multiplying high,” said Leif-Erik Sander, head of the Infection Immunology and Vaccine Research Research Group at the Charité in Berlin, the Science Media Center . “In the later phase, the disease is primarily fueled by a misdirected immune reaction. In this phase, patients usually develop self-neutralizing antibodies.”
Passive immunization
For Sander, however, it is conceivable that neutralizing antibodies could be used as a passive immunization. “This could be imagined, for example, in an outbreak in a nursing home. Patients with congenital or acquired disorders of their own antibody production could also benefit from these drugs.”
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The WHO program has secured monoclonal antibody production capacity for $ 320 million at a Fujifilm Diosynth Biotechnologies facility in Denmark. According to the document, this should be sufficient for around 4 million doses. A further $ 110 million is earmarked for regulatory approvals and other pre-market processes, and $ 220 million is to fund clinical trials. According to Reuters, other manufacturers such as Roche, Regeneron and Novartis are also holding talks with representatives of the program.
Dexamethasone helps ventilated patients
Dexamethasone is a so-called corticosteroid. In fact, it is primarily intended to treat inflammatory diseases and to reduce the body’s immune response when treating allergies and autoimmune diseases. Since inflammation occurs in many severe Covid-19 courses, the drug could also play an important role in the treatment of this disease. The European Medicines Agency (EMA) endorses the use of dexamethasone in patients who need oxygen therapy. She has evaluated the results of the RECOVERY study at Oxford University, which has been investigating various treatment methods for Sars-CoV‑2 infections since March. According to the results, the drug shows a significantly increased chance of survival, especially in artificially ventilated patients. With dexamethasone, 29 percent died within 28 days of starting treatment, writes the Federal Institute for Drugs and Medical Devices (BfArM). In contrast, 41 percent of the patients who received the usual treatment died. A Unitaid spokeswoman told Reuters that the steroid dexamethasone and its alternative hydrocortisone were the most promising of the drugs already known. In contrast, Remdesivir, which was originally tested for use against Ebola, is neither procured nor financed.
The EU and Germany continue to buy remdesivir
This does not come as a surprise, since a WHO study in mid-October came to the conclusion that the active ingredient from the US manufacturer Gilead Sciences shows little or no benefit in the treatment of Covid 19 patients. This contrasts with a study by the New England Journal of Medicine, the final version of which was published yesterday. Among other things, it came to the conclusion that patients treated with Remdesivir had a mean recovery time of ten days, while the placebo group needed 15 days. Governments also continue to rely on remdesivir. Among other things, according to Reuters, Germany announced the purchase of more than 150,000 cans this week. On October 7, the EU Commission signed a framework agreement with Gilead for the joint procurement of up to 500,000 treatment cycles.