The MRHA said the pill, taken after a person is infected, is not a replacement for vaccines as it urged the public to continue coming forward for their jabs.
A Covid treatment developed by vaccine-maker Pfizer has been approved in the UK for people who are most at risk from developing serious disease.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made the announcement on Friday after the treatment, which comes in a pill form and is called Paxlovid, was found to be safe and effective at reducing the risk of hospitalisation and death.
The health body added it was too early to say whether Omicron has any impact on the effectiveness of Paxlovid.
Dr June Raine, MHRA chief executive, said: “Today we have given our regulatory approval for Paxlovid, a Covid-19 treatment found to cut Covid-19 related hospitalisations and deaths by 89 per cent when taken within three days of the start of symptoms.
“We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting before Covid-19 has progressed to a severe stage.
“I hope the announcement today gives reassurance to those particularly vulnerable to COVID-19, for whom this treatment has been approved. For these individuals, this treatment could be life-saving.”
Friday’s announcement followed a rigorous review of Paxlovid’s safety, quality and effectiveness by the UK regulator and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.
Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication.
This prevents it from multiplying, keeping virus levels low and helping the body to overcome the viral infection. Ritonavir slows the breakdown of the second ingredient PF-07321332 in the body, thereby increasing its effectiveness.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “The Commission on Human Medicines and its Covid-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Paxlovid.
“Based on this data, it is clear Paxlovid is another safe and effective treatment to help us in our fight against Covid-19. As it is deployed, we will monitor its effectiveness and safety in the real world, including any drug interactions, as we do with all medicines. Any side effects should be reported to the MHRA using the Yellow Card scheme.”
Sajid Javid, the health and social care secretary, said: “The UK has been a world leader at finding and rolling out Covid-19 treatments to patients. This is further proved by the MHRA being one of the first in the world to approve this life-saving antiviral.
“We are also leading the whole of Europe in the number of antivirals we’ve bought per person – with over 2.75 million courses of this antiviral secured for NHS patients by the Antivirals Taskforce.
“The booster campaign, testing and antiviral defences ensure our country is in the strongest possible position to deal with the threat posed by Omicron as we head into the new year.”
Covid cases, fuelled by the more contagious Omicron variant, continue to soar in the UK going into the new year.
Confirmed infections hit another record high on Thursday as 189,213 cases were reported across the UK.
Meanwhile, an estimated 2.3 million people in the UK had Covid in the week ending December 23, up from 1.4 million in the week to December 16 and the highest number since comparable figures began in autumn 2020, the Office for National Statistics said.
