Translate the text from Welsh to English.



 
Mae’r Asiantaeth Rheoleiddio Meddyginiaethau a Chynhyrchion Gofal Iechyd (MHRA) bellach wedi awdurdodi’r brechlyn cyntaf fel brechlyn diogel ac effeithiol ar sail proses adolygu arbenigol, annibynnol a manwl o dystiolaeth o dreialon clinigol graddfa fawr.


Brechlyn Pfizer Biontech yw’r brechlyn cyntaf i gael cymeradwyaeth yr MHRA yn y Deyrnas Unedig. Bydd 40 miliwn dos o’r brechlyn ar gael cyn bo hir i’w dosbarthu ledled y DU, a bydd Cymru yn cael ei dyraniad yn ôl ei phoblogaeth.


Mae’n bosibl na fyddwn yn gweld effeithiau’r brechlyn yn genedlaethol am rai misoedd ac mae’r cyngor ar ddiogelu Cymru yn parhau’n berthnasol i bawb; lleihau’ch cysylltiadau â phobl eraill gymaint â phosibl, cadw pellter o 2m oddi wrth bobl eraill, golchi’ch dwylo’n rheolaidd, gwisgo gorchudd wyneb lle bo hynny’n ofynnol ac osgoi cyffwrdd arwynebau y mae pobl eraill wedi’u cyffwrdd, lle bynnag y bo hynny’n bosibl.


Cymeradwyaeth yr MHRA yw’r cam cyntaf yng nghynllun Cymru ar gyfer cyflwyno brechlyn, gwaith sydd wedi bod yn cael ei baratoi ers mis Mai. Mae sawl cam i’w ddilyn o hyd cyn i’r brechlyn gyrraedd y rhai sydd â’r angen mwyaf a chyn y bydd yn barod i’w ddefnyddio, ond mae disgwyl i’r broses hon ddigwydd yn ystod yr wythnos nesaf.


Mae’r camau hyn yn cynnwys:


* Y Cyd\-bwyllgor ar Imiwneiddio a Brechu (JCVI) i gwblhau a chyhoeddi ei ganllawiau ar gyfer y DU gyfan
* Cwblhau deunyddiau hyfforddi ar gyfer staff a thaflenni gwybodaeth i gleifion
* Hyfforddi imiwneiddwyr profiadol ar gyfer y brechlyn penodol hwn
* Pob bwrdd iechyd yng Nghymru i awdurdodi fframweithiau cyfreithiol terfynol i ganiatáu i weithwyr iechyd proffesiynol cofrestredig roi’r brechlyn i gleifion.


Bydd y brechlyn – sydd angen ei roi mewn dau ddos – yn cael ei flaenoriaethu i ddechrau ar gyfer pobl 80 mlwydd oed a hŷn, staff a phreswylwyr catrefi gofal, a’r rhai sy’n gweithio ym maes iechyd a gofal cymdeithasol.


Bydd y cyflenwadau cyntaf o’r brechlyn yn cael eu darparu ym mhrif safleoedd y byrddau iechyd ac mewn canolfannau brechu lleol pwrpasol, gan fod angen storio brechlyn Pfizer Biontech ar dymheredd isel iawn. Mae’r byrddau iechyd eisoes wedi penderfynu ar y canolfannau hyn ac maent wrthi’n eu paratoi i weithredu.


Pan fydd y cyflenwadau yn cynyddu a brechlynnau eraill yn cael cymeradwyaeth yr MHRA, bydd grwpiau eraill yn cael cynnig y brechlyn yn ôl blaenoriaeth a’r risg o gymhlethdodau difrifol a marwolaeth.


Bydd unigolion yn y grwpiau blaenoriaeth ar gyfer brechlyn COVID\-19 yn cael eu gwahodd gan eu cyflogwr neu eu bwrdd iechyd. Bydd y gwahoddiad yn darparu gwybodaeth am y brechlynnau COVID\-19, gan gynnwys ble i fynd a beth i’w wneud ar ddiwrnod eu hapwyntiad.


Mae pobl yn cael eu hannog i aros i gael eu gwahodd a pheidio â gofyn i’w fferyllydd na’u meddyg teulu. Byddant yn cael eu gwahodd drwy systemau’r GIG.


Mae cynlluniau ar waith i frechu pobl sy’n gaeth i’r tŷ a phobl mewn cartrefi gofal cyn gynted ag y mae’n bosibl gwneud hynny’n ddiogel, gan fynd â’r brechlyn wedi'i cymderadwyo yn ddiogel atynt gan ddefnyddio gwasanaeth symudol, unwaith byddant wedi'u clirio ar y biden hwn.


Mae’r broses o ddatblygu brechlynnau’r coronafeirws wedi bod mor llym â’r broses ar gyfer unrhyw frechlyn arall ond yn sgil y pandemig mae wedi’i chyflymu drwy gyllid prydlon, byd\-eang a llai o waith papur. Nid yw hyd y treialon wedi’i leihau, ac mae’r mesurau diogelwch arferol yn dal i fod ar waith.


Ni fydd y brechlyn yn orfodol a bydd pobl yn gallu dewis cael y brechlyn ai peidio. Bydd gwybodaeth yn cael ei darparu i bobl cyn cael eu brechu i roi sicrwydd iddynt ynglŷn â diogelwch cleifion a bydd prosesau cydsynio cadarn ar waith.


Dywedodd Prif Swyddog Meddygol Cymru, Dr Frank Atherton:



> “Mae’n wych gallu dweud o’r diwedd bod y brechlyn COVID\-19 cyntaf wedi cael y golau gwyrdd. Rydyn ni nawr yn gwybod bod gennym ni frechlyn diogel ac effeithiol i’w ddefnyddio ar draws y Deyrnas Unedig – dyma’r newyddion cadarnhaol rydw i a chynifer o bobl eraill ar draws y wlad wedi bod yn aros amdano.
> 
> 
> “Mae pob un o sefydliadau’r Gwasanaeth Iechyd Gwladol ar draws Cymru wedi ymateb i’r her oedd o’u blaen ac wedi hen ddechrau cynllunio ar gyfer brechlyn posibl. Rydym wedi cynnal ymarferion i brofi ein trefniadau dosbarthu a storio, a sicrhau bod modd inni gludo’r brechlyn yn ddiogel i bob rhan o Gymru.
> 
> 
> “Mae angen edrych ar rai camau o hyd, ond pan fydd yr holl fesurau diogelu yn eu lle, bydd modd dechrau brechu. Cymharol ychydig o frechlynnau fydd ar gael i ddechrau, rhai y cynghorwyd eu bod fwyaf angen y brechlyn yn gyntaf, drwy ddulliau wedi'u cymeradwyo. Bydd cyhoeddiad llawn am yr amserlen yng Nghymru yn dilyn dros y diwrnodau nesaf.”


Dywedodd y Prif Weinidog, Mark Drakeford:



> “Mae’r newyddion heddiw yn lygedyn o obaith ar ben draw twnnel hir a thywyll.
> 
> 
> “Rydyn ni’n gwybod bod rhai aelodau o’n cymunedau mewn llawer mwy o berygl nag eraill o ddioddef cymhlethdodau difrifol yn sgil COVID\-19, felly ein blaenoriaeth fydd eu hamddiffyn nhw i ddechrau.
> 
> 
> “Tra bod y brechlynnau cyntaf yn cael eu rhoi mewn safleoedd sefydlog a lleoliadau galwedigaethol, ac i ddiogelu ein gwasanaethau iechyd a gofal cymdeithasol, rhaid inni i gyd barhau i wneud ein rhan i atal lledaeniad y coronafeirws: golchi ein dwylo yn rheolaidd, cadw pellter cymdeithasol a gwisgo gorchudd wyneb lle bynnag bo hynny’n ofynnol i ddiogelu eich hunan ac eraill.”


Dywedodd is\-gadeirydd Bwrdd y Rhaglen Brechlynnau COVID\-19, Richard Roberts o Iechyd Cyhoeddus Cymru:



> “Naw mis yn unig ar ôl i Sefydliad Iechyd y Byd gyhoeddi pandemig byd\-eang, mae’r brechlyn diogel ac effeithiol cyntaf ar gael i’w ddefnyddio yng Nghymru, gyda brechlynnau eraill hefyd i ddilyn. Mae hyn yn llwyddiant sylweddol. Mae pawb wedi bod yn paratoi ers misoedd i gyflawni’r rhaglen brechlynnau COVID\-19, ac fe fydd yn gyffrous iawn gallu dechrau, yn syth pan fydd y camau olaf yn cael eu rhoi yn eu lle i gyflawni’r rhaglen yn ddiogel.”







Translation:


 
The Medicines and Healthcare Products Regulatory Agency (MHRA) has now authorised the first vaccine as safe and effective on the basis of detailed independent expert review of evidence from large scale clinical trials.


The Pfizer Biontech vaccine has become the first to receive MHRA clearance in the UK and 40 million doses of the vaccine will shortly be available for delivery across the UK, with Wales getting its allocation based on population.


The effects of the vaccine may not be seen nationally for many months and the advice on keeping Wales safe remains the same for everyone; keep contacts with other people to a minimum, keep a 2 metre distance from others, wash hands regularly, wear a face covering where required and avoid touching surfaces others have touched, wherever possible.


Approval from the MHRA is the first step of Wales’ roll\-out plan, which has seen preparations on\-going since May. There are still a number of stages which need to happen before the vaccine reaches those in highest need and is ready for use, but this process is expected to happen over the next week.


These stages include:


* The Joint Committee on Vaccination and Immunisation (JCVI) finalising and publishing their guidance for the whole of the UK
* Finalising training materials for staff and patient information leaflets
* Training of experienced immunisers for this particular vaccine
* Final legal frameworks to allow registered health professionals to administer the vaccine to patients need to be authorised by each Health Board in Wales.


The vaccine \- which needs to be administered in 2 doses \- will initially be prioritised and available for those aged 80 and over, care home staff and residents and those working within health and social care.


Pfizer Biontech vaccine needs to be stored at ultra\-low temperatures. These centres have already been decided by Health Boards and are in the process of being stood\-up.


As further supplies become available and additional vaccines receive MHRA approval, a staged approach will see other groups be offered the vaccine, based on risk of serious complications and deaths.


Individuals in the priority groups for a COVID\-19 vaccine will receive an invitation from their employer or health board providing information about the COVID\-19 vaccines, telling them where to go and what to do on the day of their appointment.


People are urged to wait to be invited, which will happen through NHS systems. Please do not ask your pharmacist or GP.


There are plans in place for people who are housebound and for care homes to be vaccinated as soon as safely possible, with the approved vaccine being safely taken to them using a mobile service, once cleared for this purpose.


The development process for coronavirus vaccines has been as stringent as any other but the process in the face of the pandemic has been sped up by prompt, world\-wide funding and a reduction in paperwork. The length of the trials have not been shortened, and the usual safety measures remain in place.


The vaccine will not be mandatory and people will be able to choose whether they take up the vaccine or not. Information will be provided to people before vaccination to reassure them about patient safety and robust consent processes will be in place.


The Chief Medical Officer for Wales, Dr Frank Atherton, said:



> “It is fantastic to finally say that the first COVID\-19 vaccine has been given the green light. We know now that we have a safe and effective vaccine for use across the UK \- this is the positive news I and so many across the country have been waiting for.
> 
> 
> “All our NHS organisations across Wales have embraced the challenge presented to them and are at the advanced stages of planning for the arrival of a vaccine. We have tested distribution and storage arrangements to ensure we can get vaccine safely to every part of Wales.
> 
> 
> “There’s still a few stages we need to work through but once all these safeguards are in place, vaccination can begin. There will only be relatively small amounts of the vaccine at first, those who have been advised as most needing the vaccine first, through approved delivery mechanisms. A full announcement around the timetable for roll\-out in Wales will follow in the next few days.”


The First Minister, Mark Drakeford, said:



> “Today’s news is a small glimmer of light at the end of what has been a long and dark tunnel.
> 
> 
> “We know some people within our communities are much more at risk than others from the serious complications of COVID\-19, which is why the new vaccine is being prioritised to protect them first.
> 
> 
> “Whilst these first doses are given at fixed sites and occupational settings, and to protect our NHS and social care services, we must all continue to do our bit to prevent the spread of coronavirus: regular hand washing, social distancing, and wearing a face covering where required to protect yourself and others.”


Vice\-chair of the COVID\-19 Vaccine Programme Board, Richard Roberts from Public Health Wales, said:



> “It is a significant achievement that only 9 months after WHO announced the global pandemic that we now have the first safe and effective vaccine available for use in Wales, and other vaccines to follow. Everyone has been preparing for months to deliver the COVID\-19 vaccine programme, and it is very exciting that we will be able to begin, once the final steps have been put in place so that the programme can be delivered safely.”