Published: Sat, October 17, 2020
Medical | By

Facing Many Unknowns, States Rush To Plan Distribution Of COVID-19 Vaccines

Facing Many Unknowns, States Rush To Plan Distribution Of COVID-19 Vaccines

Its vaccine is in late stage trials in Brazil, Indonesia and Turkey, and the company has said that an interim analysis of Phase 3 trial data could come as early as November.

A document was sent to outside researchers running the 60,000-patient clinical trial stating that a "pausing rule" has been met, that the online system used to enroll patients in the study has been closed. The company declined to provide further details. "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information", the company said in a statement.

The company said even serious adverse events "are an expected part of any clinical study, especially large studies".

"We are in discussions with numerous parties including the United Kingdom government around a COVID-19 challenge study, and once any of those contracts are signed we will make an announcement", said Open Orphan's executive chairman, Cathal Friel.

Pallard, a professor of pediatric and immunity at the University of Oxford, said in a BBC radio program - In this context, we are at this time, any misinformation, where we are trying to think of an intervention, which we will see in the future epidemic To help, whether they are treatment or vaccine, anything that can be very unsafe.

Given the size of the trial, it's not surprising that study pauses could occur, and another could happen if this one resolves, a source said. "We must save lives with the tools we have at hand", Tedros said.

In these tightly-controlled trials, volunteers are given a vaccine and then about a month later are deliberately infected with the disease under controlled conditions.

The FDA noted that a vaccine candidate must be at least 50% effective to receive emergency use authorization.

Vector's drug was registered before completing phase three trials, two months after Mr Putin announced approval of Sputnik V as the world's first coronavirus vaccine. The CDC playbook notes that the vaccines will likely require cold chain storage (possibly "ultra-cold" storage, which is colder than Antarctica), must be given in two doses a certain number of days apart, and could have a minimum order of 1,000 doses.

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