Germany says coronavirus vaccine will be safe

Clea Skopeliti
<p>The regulator will meet on 29 December to decide whether to approve Pfizer and BioNTech’s candidate</p> (REUTERS)

The regulator will meet on 29 December to decide whether to approve Pfizer and BioNTech’s candidate


The same rigorous approval standards are being applied to the coronavirus vaccine candidates as for other medicines, Germany’s science minister has said, adding that any approved jab will be voluntary.

Anja Karliczek said the key to gaining widespread public support for the immunisation is ensuring the same standards are applied across the board.

Authorities will educate the public about any possible side effects that could occur after vaccination, including headaches, localised pain and fever. Vaccination against the virus will not be mandatory, Ms Karliczek said.

The rapid pace of the vaccines’ development is down to huge efforts by scientists, as well as early funding and experience from previous vaccines, Marylyn Addo, a doctor at Hamburg's UKE hospital who is working in vaccine trials, said.

The European Medicines Agency will meet on 29 December to decide if there is enough data about the safety and efficacy of Pfizer and BioNTech’s Covid-19 vaccine for it to be approved.

The regulator said it could decide as early as 12 January whether to approve a separate vaccine developed by Moderna.

BioNTech and Pfizer have already requested emergency approval from the US Food and Drug Administration and the UK regulator MHRA, as well as submissions for approval in other countries including in Australia, Canada and Japan.

If approved, BioNTech’s vaccine could begin to be used in Europe before the end of 2020, after clinical trials of 44,000 participants showed the vaccine to be 95 per cent effective last month.

Sarah Gilbert, the professor of vaccinology behind the Oxford vaccine, which is being manufactured by AstraZeneca, has previously said no corners have been cut in the approval process.

“We’ve been able to find ways to save time when going through all the normal processes,” she told The Independent. “We’ve worked with the regulators and ethical committee to minimise the time it takes to get to approval, but the approval is still the full approval – it’s not missing anything.”

She referred to “accelerated procedures” that have helped to reduce unnecessary waiting time. “Normally we can’t mention the trial and ask anyone to consider taking part until it’s all completely approved,” she said. “This time we were allowed to advertise the trials and contact people.”

Regulatory bodies have also accelerated the speed at which they work, introducing rolling reviews were introduced to assess clinical trial data as it became available.

The quick-paced developments have been accompanied by a rise in anti-vaxxers, promoting conspiracy theories and unsubstantiated safety fears.

Read More

Pfizer request emergency use for Covid vaccine from European regulator

BioNTech, Pfizer ask Europe to OK vaccine for emergency use

Red Cross chief urges vaccine 'fake news' fight

EU regulator ‘very hopeful’ of delivering positive verdict on vaccines

MPs take part in vaccine trials to encourage more Bame participants