Friday, 5 February 2021

Singapore approves Moderna's COVID-19 vaccine; first shipment to arrive around March 2021

Health Sciences Authority's review of clinical data shows it is 94% effective
By Linette Lai, Political Correspondent, The Straits Times, 4 Feb 2021

Singapore has approved American pharmaceutical company Moderna's coronavirus vaccine for local use, with the first shipment expected to arrive around next month if all goes according to plan.

The vaccine will be progressively rolled out for individuals aged 18 and older, said the Ministry of Health (MOH) yesterday.

Singapore is the first Asian country to approve Moderna's Covid-19 vaccine, which is the second one to be given the green light here after the Pfizer-BioNTech vaccine was approved last December.

More vaccines from both companies will continue to arrive over the course of the year, MOH said.

In a separate statement, the Health Sciences Authority (HSA) said its review of the clinical data has shown that the Moderna vaccine is 94 per cent effective, with the benefits outweighing the risks.

In other words, the vaccine led to a 94 per cent reduction of symptomatic Covid-19 infections in vaccinated individuals, compared with a similarly sized group of unvaccinated people.

This data was based on a clinical trial of 30,000 people conducted in the United States. Trial participants ranged in age from 18 to 95 years.

The Moderna vaccine requires two doses administered 28 days apart, while the Pfizer vaccine's two doses are taken 21 days apart.

The Moderna vaccine can be stored at a regular freezer temperature of minus 20 deg C, whereas the Pfizer vaccine must be stored at minus 70 deg C.

Both vaccines "teach" the cells in the body to make a protein that triggers an immune response to produce antibodies to fight the virus. Reported side effects from both vaccines are similar and include pain, swelling at the injection site, fatigue, headache, muscle ache, fever, chills, vomiting and joint pain after vaccination.

These reactions are generally associated with vaccinations, and typically resolve on their own after a few days, HSA said.

The vaccine has received interim authorisation under the Pandemic Special Access Route, which means Moderna has to monitor the longer-term efficacy of the vaccine in order to determine how long it protects against Covid-19. It must also follow up on the safety of the vaccine for a longer period of time.

Singapore's expert committee on Covid-19 vaccination, which carried out an independent review of the Moderna vaccine, said yesterday that it is satisfied with the vaccine's safety and efficacy.

Its safety profile is consistent with the standards set for other registered vaccines used in the immunisation against other diseases.

However, the committee cautioned that pregnant women and severely immuno-compromised people, as well as those under 18, should not take the vaccine yet.

Singapore aims to have enough vaccines for citizens and long-term residents in the country by the third quarter of this year, although it may take until the end of the year to get the whole population inoculated. Vaccination is voluntary and free.

Singapore has signed advance purchase agreements with Pfizer, Moderna and Sinovac, and is in confidential talks with other companies.

MOH said more than 175,000 people had taken their first dose of the Pfizer vaccine as at Tuesday, with around 6,000 in this group having taken the second dose. "In two weeks' time, they will be adequately protected against Covid-19," it added.

The ministry urged locals to get vaccinated in order to protect themselves and their loved ones, as well as those in the wider community who cannot be vaccinated due to medical reasons.

The expert committee also pointed out that Singapore remains at risk of a surge in coronavirus cases even though the local virus transmission rate is low.

"Therefore, it is important that we achieve as comprehensive a coverage of Covid-19 vaccination as possible across the entire population," it added.

Side effects for Moderna COVID-19 vaccine similar to Pfizer's
By Linette Lai, Political Correspondent, The Straits Times, 4 Feb 2021

Side effects for the newly approved Moderna Covid-19 vaccine are similar to those reported about the Pfizer-BioNTech vaccine, which is currently being used here.

They include pain, swelling at the injection site, fatigue, headache, muscle ache, fever, chills, vomiting, and joint pain after vaccination.

Some symptoms, such as fatigue, headaches and muscle and joint aches may be more severe in a small number of people, said the Health Sciences Authority (HSA) yesterday.

But it added that these side effects typically resolve on their own within a few days, stressing that the vaccine's benefits outweigh the risks.

"These symptoms are reactions generally associated with vaccinations and expected as part of the body's natural response so as to build immunity against Covid-19," it said.

The HSA has granted interim authorisation for the Moderna vaccine under the Pandemic Special Access Route, which facilitates access to new vaccines, medicines and medical devices during such crises.

It is approved for use in people aged 18 and up, and involves two doses taken 28 days apart.

But certain groups of people - such as pregnant women or the severely immunocompromised - should not get the jab. This is because safety and efficacy data is not yet available for these groups.

The HSA said a small proportion of people will suffer severe allergic reactions upon vaccination, as is the case for all vaccines.

They could include people with a history of anaphylaxis, as well as those with severe or multiple allergies to medicines and food. These groups should not get the vaccine, it said.

The Moderna vaccine has an efficacy of 94 per cent - slightly lower than Pfizer's 95 per cent. This data was gleaned from a phase three clinical trial of 30,000 people aged between 18 and 95.

It means the vaccine led to a 94 per cent reduction of symptomatic Covid-19 infections in a vaccinated group of people, as compared with a similarly sized group that was not vaccinated.

The HSA said the vaccine's safety profile was "generally consistent with other registered vaccines used in immunisation against other diseases".

HSA chief executive Mimi Choong added that her organisation has applied "the same rigorous evaluation processes, as with all vaccines, to ensure that the Moderna Covid-19 vaccine has met the required high standards of quality, safety and efficacy".

As a condition of it receiving interim authorisation, Moderna has to monitor the longer-term efficacy of the vaccine to determine how long it can protect people against Covid-19.

It will also have to follow up on the vaccine's safety over a longer period of time, in order to determine its full safety profile.

At present, available data shows that the Moderna vaccine is effective two months after both doses of the vaccine are completed, with "no signs of waning protection".

The HSA said it will continue to review the data in order to ensure that the benefits of vaccination continue to outweigh the risks.

Interim authorisation can be terminated at any time, for example, if new data shows that the vaccine poses too high a risk.

Commenting on the new vaccine, Professor Teo Yik Ying, dean of the Saw Swee Hock School of Public Health at the National University of Singapore, said it diversifies the supply chain of vaccines into Singapore.

"Given the recent developments on how vaccine supply may be disrupted due to production issues and shifting needs globally, it is important for every country to build up a robust supply pipeline, to avoid over-reliance on a single producer which may invariably affect national vaccination strategies."

* First shipment of Moderna's COVID-19 vaccine arrives in Singapore on 17 February, ahead of schedule
By Toh Ting Wei, The Straits Times, 18 Feb 2021

The first shipment of Moderna's Covid-19 vaccine has arrived here, as Singapore ramps up its vaccination drive.

A Singapore Airlines (SIA) freighter flew in from Brussels, Belgium, with the shipment yesterday. After a transit stop in Sharjah, in the United Arab Emirates, the plane touched down at Changi Airport at about 1.40pm.

The Moderna vaccine was delivered earlier than expected, with the Ministry of Health saying on Feb 3 that the first shipment would arrive around March.

Education Minister Lawrence Wong, who co-chairs the Covid-19 task force, said in a Facebook post that another batch of the Pfizer-BioNTech vaccine had also arrived earlier yesterday.

He said: "These shipments will enable us to progressively roll out our vaccination programme, with vaccination for seniors in the community set to begin...

"More vaccines from both Moderna and Pfizer-BioNTech will arrive over the coming months."

Mr Wong said the Government would continue to monitor the vaccine supplies in order to meet its target of vaccinating all Singaporeans and long-term residents by the end of this year.

Prime Minister Lee Hsien Loong said on Facebook that he hopes seniors will book their Covid-19 vaccination appointments when their turn comes.

"Until then, do continue to follow safety regulations, wear masks, and remember safe distancing," he added.

SIA said in a statement yesterday that the Moderna vaccine shipment was prioritised for loading in Brussels. It was also prioritised for unloading in Singapore.

SIA's senior vice-president for cargo Chin Yau Seng said the carrier has in the last two months ferried the Pfizer-BioNTech Covid-19 vaccine to Singapore, Australia and New Zealand. It has also ferried the Sinovac Covid-19 vaccine to Indonesia.

Meanwhile, Transport Minister Ong Ye Kung said in a Facebook post on the Moderna vaccine's arrival yesterday that SIA and ground handler Sats have been busy with cargo deliveries.

He added: "This has put to good use our capabilities to handle temperature-sensitive pharmaceuticals and the connectivity with cities around the world."

The Moderna vaccine is the second Covid-19 vaccine to be approved for use in Singapore after Pfizer-BioNTech's.

The Health Sciences Authority had said its review of available clinical data found the Moderna vaccine demonstrated a high efficacy of 94 per cent, with the benefits outweighing the risks.

Both the Moderna and Pfizer-BioNTech vaccines use mRNA technology, which involves injecting snippets of the virus' genetic material into the body to stimulate an immune response.

Reported side effects from both vaccines are similar and include pain, swelling at the injection site, fatigue, vomiting and joint pain.

The Moderna vaccine requires two doses 28 days apart, while the Pfizer-BioNTech vaccine's two doses are given 21 days apart.


COVID-19 safe management measures tightened from 26 January 2021; senior citizens to be vaccinated from 27 January, starting with pilots in Ang Mo Kio and Tanjong Pagar

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