Evidence COVID-19 vaccinations are approved (FOI)

Request

A

Please supply me with the evidence that the Covid-19 vaccinations have been fully approved and are no longer in trial stages. Including the animal trials. For each vaccine used on the Island.

B

What is the definition of an emergency license for vaccine and the difference in testing for temporary, emergency and fully approved vaccines?

C

What body in Jersey decides the vaccines are safe for use in Jersey and what those procedures for safety checks are?

D

Why do the corporations behind making the vaccines (on their official websites) state it is on emergency use only and their definition of this is it is still in fact in trial stages? Not fully approved by FDA.

E

Why is Jersey saying they are fully approved when other countries and the actual vaccine companies say they are not fully approved?

Response

A

Information regarding this question can be found within the following previous Freedom of Information request and response. Article 23 of the Freedom of Information (Jersey) Law 2011 has been applied.

Clinical trials regarding the COVID-19 vaccines currently in use (FOI)

Data on clinical trials including animal studies are not Government of Jersey owned or administered data. This information is available in the public domain.

B

The Government of Jersey does not issue or use emergency licences for medicines (including vaccines) and so there is no Jersey definition. Each regulatory body will have their own working definitions for approval.

The type of regulatory approval does not reflect differences in testing. All medicines including vaccines undergo thorough pre-clinical and clinical trials prior to regulatory body approvals. The type of approval given by regulatory bodies is based on the outcomes of clinical trials.

Further information on licencing of COVID-19 vaccines and clinical trials can be found in the public domain:

MHRA guidance on coronavirus (COVID-19)

C

Medicines, including vaccines, which are used in Jersey are obtained via the UK supply chain. Therefore, all medicines used will have been subject to the rigorous regulatory requirements of the Medicines and Healthcare Regulatory Agency (MHRA), who are responsible for ensuring medicines meet applicable standards of safety, quality and efficacy. In addition, vaccines will be used in Jersey in accordance with recommendations by the Joint Committee on Vaccination and Immunisation (JCVI). This information can be found in the public domain.

D

For clarification the FDA is an American regulatory body and any references to FDA approval of a particular vaccine are only relevant to the USA and the FDA approval process for that particular vaccine. FDA approval is only relevant to the USA whereas the EU Medicines Agency and Medicines and Healthcare products Regulatory Agency (MRHA) are the FDA equivalent body for the EU and UK respectively. On 23 August 2021 the FDA fully approved the Pfizer BioNtech (Comirnaty) vaccines. This information is available in the public domain.

E

The three vaccines currently in use in Jersey have been approved and authorised for use by both the MHRA and the EU Medicines Agency. These vaccines are:

• Pfizer BioNtech vaccine, also known as Comirnaty

• AstraZeneca (Oxford), also known as Vaxzervria

• Moderna, also known as Spikevax

Article applied

Article 23 - Information accessible to applicant by other means

(1) Information is absolutely exempt information if it is reasonably available to the applicant, otherwise than under this Law, whether or not free of charge.

(2) A scheduled public authority that refuses an application for information on this ground must make reasonable efforts to inform the applicant where the applicant may obtain the information.