Singapore grants interim approval for Moderna’s bivalent Covid-19 vaccine that targets Omicron variant

14/9/2022 3:53:00 PM

Singapore grants interim approval for Moderna’s bivalent Covid-19 vaccine that targets Omicron variant

Singapore, Covid-19 Vaccine

Singapore grants interim approval for Moderna’s bivalent Covid-19 vaccine that targets Omicron variant

SINGAPORE, Sept 14 — The Health Sciences Authority (HSA) today granted interim authorisation for Moderna's updated vaccine, which can target both the original Sars-CoV-2...

Wednesday, 14 Sep 2022 8:48 PM MYTSINGAPORE, Sept 14 — The Health Sciences Authority (HSA) today granted interim authorisation for Moderna's updated vaccine, which can target both the original Sars-CoV-2 coronavirus as well as the Omicron BA.1 strain.

The Spikevax Bivalent Original/Omicron Covid-19 vaccine by the American pharmaceutical firm has been authorised for use as a booster vaccine in individuals aged 18 and older, HSA said in a statement.These individuals must have already received their primary series of Covid-19 vaccinations.

Read more:
Malay Mail »

D-Day in Padang Serai and Tioman

ALOR SETAR: Although the 15th General Election (GE15) is done and dusted, it’s D-Day in Padang Serai near here and Tioman in Pahang. Read more >>

Court allows Muhammad Shafee to amend date of release for passport to AustraliaKUALA LUMPUR (Sept 13): The High Court here on Tuesday (Sept 13) allowed an application by lawyer Tan Sri Muhammad Shafee Abdullah, who is facing charges for money laundering, to amend the date for the temporary release of his passport for his travel to Australia for a meeting with a King's Counsel from the United Kingdom.Muhammad Shafee applied to amend the date, which was initially from Sept 6 to Sept 12, to Sept 15 to Sept 19, 2022.Judge Datuk Muhammad Jamil

DAP to fix anti-hopping loophole in party constitution through Sept 25 congressKUALA LUMPUR, Sept 14 — DAP will hold a special congress this September 25 to amend its party’s constitution to be in line with the recently gazetted anti-party hopping...

Naza Group chair’s battery case postponed to Sept 20The lead defence counsel was unable to attend the hearing. Ulcer as well?

Covid-19 (Sept 12): 1,847 new cases, 5 deathsReported Covid-19 deaths are continuing on downward trend.

Covid-19 (Sept 13): 1,942 new cases, 6 deathsHospitalised Covid-19 patients are 25 pct lower than a month ago.

Najib still warded at HKL, 1MDB trial vacatedThe trial will resume on Sept 26. 👆 😂 Billion Dollar Whale : The Story of Jho Low by Tom Wright & Bradley Hope - The Summary - That’s what he planned…

for the latest news you need to know.A KUALA LUMPUR (Sept 13): The High Court here on Tuesday (Sept 13) allowed an application by lawyer Tan Sri Muhammad Shafee Abdullah, who is facing charges for money laundering, to amend the date for the temporary release of his passport for his travel to Australia for a meeting with a King's Counsel from the United Kingdom.for the latest news you need to know..

Wednesday, 14 Sep 2022 8:48 PM MYT SINGAPORE, Sept 14 — The Health Sciences Authority (HSA) today granted interim authorisation for Moderna's updated vaccine, which can target both the original Sars-CoV-2 coronavirus as well as the Omicron BA.1 strain. Judge Datuk Muhammad Jamil Hussin allowed Muhammad Shafee's application after deputy public prosecutor Afzainizam Abdul Aziz did not object to it. The Spikevax Bivalent Original/Omicron Covid-19 vaccine by the American pharmaceutical firm has been authorised for use as a booster vaccine in individuals aged 18 and older, HSA said in a statement. "When the law was debated in Parliament, the minister said the loophole could be closed by the party’s constitution so that is what we are doing. These individuals must have already received their primary series of Covid-19 vaccinations. This is because the King’s counsel, Geoffrey Robertson, needs time to study the documents first, before he can give any advice or recommendation to Muhammad Shafee, he said, adding that his client would return the passport to the court on Sept 22. In a separate statement, Moderna said that it is working with the HSA and the Singapore Government to make the vaccine available to people in Singapore this month.

The Moderna bivalent booster shot is a single dose comprising two components of 25 micrograms each, one targeting the original Sars-CoV-2 virus and another targeting the Omicron BA. The 70-year-old lawyer surrendered his passport to the court in September 2018, after he was charged with two counts of receiving money amounting to RM9. Sim said 3,672 delegates are eligible to attend the special congress which will be held at the Ideas Convention Centre in in Shah Alam, Selangor next week.1 variant. Its interim approval was granted under the Pandemic Special Access Route, which facilitates early access to critical novel vaccines and medicine during a pandemic. He is also facing two charges of engaging in transactions resulting from illegal activities, namely submitting incorrect tax returns and in violation of Paragraph 113(1)(a) of the Income Tax Act 1967 for the financial years ending Dec 31, 2013, and Dec 31, 2014. This is the first bivalent Covid-19 vaccine that has been approved in Singapore. The Bill was also part of the memorandum of understanding signed between Prime Minister Datuk Seri Ismail Sabri Yaakob and the PH coalition. “Official vaccination recommendations using this booster vaccine will be issued by the expert committee on Covid-19 vaccination and the Ministry of Health in due time,” HSA said. The oral submission has been fixed for this Sept 15.

It added that the benefits of using the bivalent vaccine as a booster outweigh the risks. This was after a careful review of data from Moderna’s pre-clinical studies, clinical trials in human volunteers, manufacturing and quality controls. There are three exceptions, however: the dissolution or cancellation of the registration of the politician’s party; the expulsion of the politician from his party; or the politician resigning from his party upon becoming Speaker of the Dewan Rakyat or his respective state assembly. In coming to its decision, HSA had also consulted experts from its medicines advisory committee and panel of infectious diseases experts, it said. May be effective against other variants HSA’s clinical review was based on an ongoing trial in its second and third phase conducted by Moderna in individuals aged 18 and above. The results showed that the bivalent booster vaccine elicited a strong immune response against the Omicron BA.

1 variant, while preserving the immune response against the original Sars-CoV-2 virus. Preliminary data from an exploratory analysis also suggested that the vaccine may stimulate antibodies against Omicron BA.4 or 5, as well as other variants such as Alpha, Beta, Delta, and Gamma, HSA said. Safety data from the clinical studies showed that the bivalent was “generally well-tolerated” and its safety profile consistent with what is known for the original original Spikevax vaccine, HSA added. Adverse events were mostly “mild-to-moderate”, HSA said.

These refer to any side effects that occur after taking the vaccine, including injection site pain, tenderness, fatigue, headache and muscle pain. HSA said that these are expected reactions that usually resolve on their own within a few days. It added that it will continue to monitor the safety of the vaccine and will require Moderna to submit data from the ongoing clinical study. “HSA will take the necessary actions and provide updates to the public if significant safety concerns are identified,” it said. — TODAY Advertisement .