November 2021 • PharmaTimes Magazine • 12
// COVID-19 //
The government has announced COVID-19 vaccine clinical trial participants in England will be offered additional approved vaccine doses for international travel to countries which currently only accept vaccination records with approved for deployment COVID-19 jabs.
Although the UK recognises those who are in COVID-19 vaccine trials as fully vaccinated for the purpose of certification, most other countries do not currently recognise clinical trial volunteers who have not had a vaccine that is approved for deployment.
As such, the government will now offer these volunteers two additional doses of an approved vaccine, allowing them to gain the necessary certification status to travel abroad with more ease.
Initially, additional doses will be offered to participants taking part in the Novavax clinical trial, which includes the majority of those in ongoing trials for vaccines not yet approved for deployment.
On top of that, people who have received two doses of a vaccine as part of a clinical trial will also be offered a booster dose, if eligible.
“The measures we have taken will allow UK COVID-19 vaccine trial participants to travel freely overseas once they have had the additional vaccinations. Those volunteers now have the flexibility to make a decision for themselves so they can, for example, visit loved ones abroad,” said professor Jonathan Van-Tam, deputy chief medical officer for England.
“We should be very clear that the results from these trials benefit the whole world, and it has to be said that if more countries around the world had reciprocated by allowing UK volunteers to enjoy fully vaccinated status for overseas travel, these measures would not have been necessary,” he added.
Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the administration of the Pfizer/BioNTech COVID-19 vaccine as a booster shot six months after the second dose.
The CHMP, which is a part of the EMA, has approved the use of the booster jab for individuals over the age of 18. Following the CHMP positive opinion, the European Commission (EC) will make a final decision on its update to the vaccine’s current Conditional Marketing Authorisation in the EU.
In the clinical trial data provided by Pfizer and BioNTech, the COVID-19 vaccine, Comirnaty, was found to elicit significantly higher neutralising antibody titers against SARS-CoV-2, and protection from both the Beta and Delta variants of the disease.
The companies are continuing to supply their vaccine doses around the world, and this includes sufficient batches for booster doses. The existing supply agreement with the EC and the US are not expected to cause any issues to the worldwide supply.
In August, the UK ordered 35 million more Pfizer/BioNTech COVID-19 vaccines to be delivered in the second half of 2021. These vaccines were purchased both as part of preparations for booster shots to be given, as well as for any new variants that emerge in the UK.
A new taskforce may be the ‘last chance’ to find the origins of COVID-19, according to WHO. 26 experts have been appointed to join the Scientific Advisory Group on the Origins of Novel Pathogens (Sago).
The question of how the virus first emerged in Wuhan remains a mystery. In February 2021, a WHO team spent four weeks in Wuhan with Chinese scientists concluded that SARS-CoV-2 had likely been transmitted from bats to humans, but there was more evidence needed to support the claim. The director general of the WHO, Dr Tedros Adhanom Ghebreyesus, has said that the investigation was in turn hindered due to lack of evidence.
A few months later in May, a controversial claim that COVID may have been leaked from a Chinese laboratory gained traction, a theory that China has strongly dismissed. However, the WHO technical lead on COVID-19, Maria van Kerkhove, also expressed that the WHO aims to conduct more international missions in China, in the hopes of engaging the country’s cooperation.
The 26 proposed members were selected for their levels of expertise in multiple areas, such as clinical medicine and animal health. According to Reuters, the newly appointed board of Sago include Marion Koopmans, Thea Fischer, Hung Nguyen, and Chinese animal health expert Yang Yungui, who took part in the previous investigation in Wuhan.
“SAGO will advise WHO on the development of a global framework to define and guide studies into the origins of emerging and re-emerging pathogens with epidemic and pandemic potential, including SARS-CoV-2,” the WHO chief said.
“The emergence of new viruses with the potential to spark epidemics and pandemics is a fact of nature, and while SARS-CoV-2 is the latest such virus, it will not be the last.”
WHO has expressed the need for analyses of stored blood samples from 2019 in Wuhan, and searches of hospital and mortality data for earlier cases, to gather evidence on the first reports of human infections.
Dr Tedros has expressed that understanding where new pathogens come from is key to preventing future outbreaks.
The UK government has entered into a supply agreement with MSD for its investigational oral antiviral medicine molnupiravir.
Molnupiravir has been evaluated in a Phase III trial for the treatment of at-risk non-hospitalised adults with mild to moderate COVID-19.
The agreement with the UK was negotiated and finalised with the Department of Health and Social Care (DHSC) – under the terms of the deal, MSD can allocate initial supplies of molnupiravir, in line with the requirements set out by the UK government.
“We are pleased to have reached this agreement for molnupiravir with the U.K. government, which represents an important step forward for this country. This agreement is part of MSD’s global access strategy so that this medicine, if approved, can quickly reach patients across the world,” said David Peacock, UK managing director, MSD. “We will continue to partner with the UK and other country governments to make it widely available, subject to regulatory review processes.”