Three months for booster shots for all after second dose of Pfizer, AZ, Sinovac, in view of high Omicron variant

 

` PETALING JAYA: Booster jabs for all Covid-19 vaccine recipients will now take place three months after they get their second shot following a decision by the Health Ministry to shorten the waiting period.

` More vaccination centres and clinics will also be opened to increase capacity.

` Previously, only Sinovac recipients got their booster shots 90 days after receiving their second dose while those on Pfizer and AstraZeneca had to wait 180 days.

` Health Minister Khairy Jamaluddin said the Covid-19 booster shots for Pfizer and AstraZeneca recipients could now be shortened to three months.

` He said recent data showed that the Omicron variant of the Covid-19 virus could cause increased transmission of infections and had higher viral binding affinity and higher antibody escape than vaccine-induced immunity or natural infections.

` “Strong evidence has accumulated over the past three weeks indicating that a Covid-19 booster vaccine is possible to increase protection against Omicron variant infections,” he told reporters here yesterday.

` A technical working group, he added, had also evaluated the existing evidence and provided new recommendations on the administration of Covid-19 booster doses.

` “All seniors aged 60 and above, and all adults who have received both doses of their vaccines (from Pfizer, AstraZeneca and Sinovac) are highly recommended to get their booster vaccine at least three months after receiving the primary vaccine.

` “Individuals with comorbidities, and residents and staff at healthcare centres will be given priority to receive the booster shots.

` “We will be using the age de-escalation approach for adults who have received two doses of their jabs, starting from 50 years and above, 40 years and above, and subsequently, 18 years and above.

 ` “Adults are expected to receive their booster shots in January and February and we will increase the capacity by opening more vaccination centres and private clinics,” he said.

` He added that heterologous vaccination – mixing vaccine types – was found to be safe and effective.

` “We will give priority to Pfizer and AstraZeneca as booster shots. However, we will look at an individual’s safety profile.

` “Sinovac will only be given to those who are contraindicated against Pfizer or AstraZeneca,” he said.

` The government, announced Khairy, would also lift the temporary travel restrictions against eight countries – South Africa, Botswana, Eswatini, Lesotho, Mozambique, Namibia, Zimbabwe and Malawi.

` “We will shift them from total ban to high-risk countries. However, we urge people to avoid any unnecessary travel to high-risk countries as the Omicron situation there is dangerous,” he said.

` Khairy said the Health Ministry was also considering taking action against the 1.4% of Covid-19 positive cases who violated the quarantine granted to them under the Surveillance and Observation Order between Dec 1 and 28.

` On another matter, he said the MySejahtera Trace (MySJ Trace) would use Bluetooth technology to allow easier close contact tracing with those who tested positive for Covid-19 in public areas.

` “It is highly recommended the public use this feature for their own safety.

` “To ensure the effectiveness of the feature, users are required to activate the Bluetooth on their devices when they are outside.

` “When a person is confirmed to be positive for Covid-19, a notification will appear through MySejahtera to request approval for the sharing of any close contact information that was detected.

` “Upon approval, MySejahtera will provide access to the Health Ministry to conduct a risk assessment on all the close contact data traced via Bluetooth before carrying out close contact tracing activities on identified individuals.

` “However, this will not take place if no approval is given by the individual and any close contact tracing will be done manually,” he said.

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Pfizer, AZ booster shots can be given at least three months after second dose, says Khairy 

 

 ` Reduce the risks: Khairy, seen at the Health Ministry in Putrajaya, says the government urges people to avoid any unnecessary travel to high-risk countries as theOmicron situation there is dangerous. — BernamaReduce the risks: Khairy, seen at the Health Ministry in Putrajaya, says the government urges people to avoid any unnecessary travel to high-risk countries as theOmicron situation there is dangerous. — Bernama

 

PETALING JAYA: Pfizer and AstraZeneca vaccine booster shots can be given at least three months after the second dose, says Khairy Jamaluddin (pic).

` The Health Minister made the announcement on the shorter interval for Covid-19 booster shots during a press conference on Tuesday (Dec 28).

` The move to shorten the interval is similar to measures taken by other countries such as Germany and Australia, which are recommending shorter booster intervals in an attempt to stop the spread of new variants.

` Khairy added that following the discovery of a confirmed Omicron case in a man in Sarawak who has no history of recent travel abroad, it is very likely that Omicron is now in the community.

` He said recent data showed that Omicron variants could cause increased transmission of infection, higher viral binding affinity and higher antibody escape than vaccine-induced immunity or natural infections.

` "Strong evidence accumulated over the past three weeks indicate that a Covid-19 booster vaccine is possible to increase protection against Omicron variant infections.

` "Results initially involving 21 million booster doses administered in the United Kingdom have shown very convincing security data.

` "In line with that, regulatory bodies such as in the United Kingdom, Canada and Australia, as well as a panel of health experts are now recommending an interval for booster dose vaccination can be given as early as three months after receiving the primer vaccine," he said at a press conference on Tuesday (Dec 28).

` Khairy added that the technical working group has also evaluated the existing evidence and provided new recommendations on the administration of Covid-19 booster doses.

` "All seniors aged 60 and above and all adults who have received both doses of their vaccines (Pfizer, AZ and CoronaVac) are highly recommended to receive their booster vaccine at least three months after receiving the primary vaccine.

` "Individuals with comorbidities, residents and staff at health care centres will be given priority to receive the booster shots.

` "We will be using the age de-escalation approach for those who are 18 years old and above and have received two doses of their jabs, starting from 50 years and above, 40 years and above, and subsequently 18 years and above.

` "Adults will receive their booster shots in January and February next year and we will increase the capacity by opening more PPV and private clinics," he said, adding that Sinovac booster shots would only be given to those who were contraindicated against Pfizer or AZ.

` Furthermore, Khairy said the government would lift the temporary travel restrictions to eight countries namely South Africa, Botswana, Eswatini, Lesotho, Mozambique, Namibia, Zimbabwe and Malawi.

` "We will shift them from total ban to high risk countries.

` "However, we urge people to avoid any unnecessary travel to the high risk countries, as the Omicron situation in these countries are dangerous," he said.

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‘Shorter interval is necessary’

 

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Covid-19: Sinovac recipients, those above 60 must get booster shots by February or have their status changed to 'incomplete', says KJ

 

 

KUALA LUMPUR: If you don't get your Covid-19 booster shot by February next year, your vaccination status may be deemed "incomplete", says Khairy Jamaluddin.

The Health Minister said the groups affected by this are those who received the Sinovac vaccine, as well as anyone who is above 60 years old.

"If these groups of individuals still have not gotten their booster shots after February 2022, their vaccination status will be changed to 'incomplete'," he said in a statement on Wednesday (Dec 16).

He said those whose status has been changed to "incomplete" would not be able to enjoy the benefits of those who have been deemed to have completed their vaccinations.

He said individuals who must get their booster shots before the end of February next year are those who had taken the Sinovac vaccine.

He added that those above 60 years old, who had taken a vaccine irrespective of the type of vaccines, will also be required to take their booster shot.

Khairy said this was in line with a recommendation by the World Health Organisation's Group of Experts on Immunisation (SAGE) advice.

He noted that the Covid-19 Immunisation Task Force — Booster (CITF-B) had approved and adopted the recommendation on Dec 8.

At present, Khairy said that Comirnaty by Pfizer-BioNTech, CoronaVac by Sinovac and AstraZeneca have been approved for use for booster shots.

The Working Technical Committee, he added, had recommended that those above 18 should get their booster shots.

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No benefits without booster

 

Get your booster: Khairy speaking at a press conference in Parliament. With him is Health director-general Tan Sri Dr Noor Hisham. — Bernama

KUALA LUMPUR: The vaccination status of those required to get their Covid-19 booster shot will be deemed “incomplete” if they fail to get their shots by February next year, says Khairy Jamaluddin.

“If these group of individuals still have not got their booster shots after February 2022, their vaccination status will be changed to ‘incomplete’,” the Health Minister told a press conference in Parliament yesterday.

He said those whose status has been changed to “incomplete” would not be able to enjoy the benefits of those who are deemed to have completed their vaccination.

Sinovac vaccine recipients are among those who must get booster shots by the February deadline.

Meanwhile, those above 60 years old, irrespective of vaccines type, will also be required to get their booster shot.

Khairy said this was in line with recommendation by the World Health Organisation’s Strategic Advisory Group of Experts (SAGE).

He added that the Covid-19 Immunisation Booster Task Force had approved and adopted the recommendation on Dec 8.

At present, Khairy said that the vaccines by Pfizer-BioNTech, Sinovac and AstraZeneca have been approved for use as booster shots.

He added those above 18 should also get their booster shots.

Booster dosing started nationwide on Oct 13 for fully vaccinated individuals to ensure the immunity received after completing their doses can be maintained for an optimal period, especially against the Delta variant.

Last month, Khairy stressed that Malaysia could face a new wave of Covid-19 infections if the administration of booster doses was not accelerated.

In a tweet later yesterday, he said in line with the government’s effort to ramp up the booster shots vaccination drive, mega PPV (vaccination centres) will be reopened starting with the Klang Valley.

“All 60 and above or Sinovac recipients must get a booster latest by February 2022 to keep (their) fully vaccinated status.

“You will get your booster appointment on MySejahtera 180 days after the second dose (Pfizer or AstraZeneca) or 90 days after the second dose (Sinovac).

“You can also contact GPs near you at https://vaksincovid.protecthealth.com.my/find to register on the waiting list,” he said.

 

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Getting ready for Covid-19 vaccines

 The dreadful year is coming to an end with optimism and hope in the air as we greet 2021.

https://youtu.be/I6I3o0DvWL0

Royal approval: UAE’s Crown Prince of Dubai Sheikh Mohammed bin Rashid Al-Maktoum receiving an injection of a Covid-19 vaccine. — AFP

 COVID-19 Worldwide Dashboard - WHO Live World Statistics

THERE’S finally light at the end of the tunnel from a dark period in modern history. The race to complete the final stage of testing the Covid-19 vaccine is almost at the finish line.

In Britain, the vaccination exercise has kicked off with people above 80 years old, since they’re the most vulnerable to the dreadful virus.

But let’s not get carried away. Only the British government has expedited the approval because it’s bracing for a huge spike with the coming winter.

The United States government only officially approved the use of Pfizer Inc’s Covid-19 vaccine on Friday, with the Food and Drug Administration (FDA) granting an emergency use authorisation for healthcare workers and elderly people in long-term care facilities in its first round of 2.9 million doses.

The FDA is responsible for protecting public health by ensuring safety, efficacy and security of human and veterinary drugs in the US. The FDA has always been used as a benchmark by most countries in providing approvals.

Last week, MyEG Services Bhd announced that it will work with Anhui Zhifei Longcom Biopharmaceutical Co Ltd (Zhifei) to obtain the Malaysian halal certification for the Chinese biopharma company’s Covid-19 vaccine, and to exclusively distribute it in Malaysia for a three-year period.

It said the two companies had signed a memorandum of understanding to cooperate in conducting Phase 3 clinical trials of Zhifei’s vaccine in Malaysia and to meet the halal status requirements of the Department of Islamic Development Malaysia (Jakim).

In September, loss-making Ho Wah Genting, which had been searching for a core-income generating business for a while, declared it was officially in the race to produce vaccines.

It announced that it had been appointed by a China-based diagnostic reagents manufacturer as its designated overseas sales agent for Covid-19 diagnostic products in Asean countries.

More recently, a Covid-19 research centre not linked to any medical institution, also sprouted and began issuing press releases to the media.

Firstly, let’s be clear that there’s nothing to stop the private sector from playing a role in the search for a vaccine source. In fact, I think it’s commendable that these companies are ready to play a complementary role.

If the intention is to help their bottom line, and in the process, propel their share prices, it’ll be up to shareholders to be mindful, and perhaps the Securities Commission to keep its eyes open.

Individuals hoping to set up a non-governmental organisation, including for Covid-19, have the right to do so, but their authority and credibility are for the public and media to decide.

The private sector, in fact, should be encouraged to take a stronger role in the fight against the pandemic, as the number of cases continue to climb in Malaysia.

The truth is, while we’ve relaxed the rules, with a crippling economy in mind, our situation has gotten worse. Let’s be honest – statistics don’t lie.

Only those with a warped mind, like conspiracy theorists, think the numbers in Malaysia have been manipulated and jacked up for political reasons. It’s an insult to dedicated professionals like Health Ministry director-general Tan Sri Dr Noor Hisham Abdullah and his team of frontliners, who haven’t taken a day off since the Movement Control Order (MCO) began in March.

The number of positive cases in Malaysia could likely be higher because only targeted areas and cases are tested, including travellers, medical treatment seekers and foreign workers.

The average daily cases (originally three digits in March and rendering us house bound) has passed the 2,000 mark now.

Most of us feel the end is near and that even with the staggering new numbers, we are certain that the cure is just round the corner, what with all the media hype over 90% efficacy by these drug companies.

Unfortunately, none of the vaccines have been approved by the National Pharmaceutical Regulatory Agency of Malaysia yet. Companies bringing in Covid-19 vaccines must also be registered with the NPRA – it doesn’t matter if these vaccines are from the UK, US, China or Russia.

I’ve been reliably informed that until today, no private companies have applied despite their announcements. So, nothing has been approved.

Like the US, Malaysia has also decided to wait until all the vaccines have completed the final stages of trials and are properly approved.

With the situation exceptionally dire there though, the FDA is reported to be ready to approve emergency use of Covid-19 vaccines in the US as more than 285,000 people have died from the virus.

But as with all testing, there will be cases of side effects, including fatalities. Tests are often called off and then resumed, which is normal, but if we are to read the Western media, only US and UK-made vaccines are good enough.

They have put the Chinese and Russian products in bad light by insinuating they are inferior products.

This isn’t just a question involving billions of dollars, but a race for political and diplomatic achievements.

It won’t be surprising if the US FDA refuses to approve the Chinese and Russian products. And if that happens, then those nations would need to turn to the World Health Organisation.

So many of us have been brain-washed into believing that everything from the West is good and most things from China are inferior or not of international standards.

The New York Times reported that researchers are currently testing 57 vaccines in clinical trials on humans, and at least 86 pre-clinical vaccines are under active investigation on animals.

I am told that China has provided its initial consignment of vaccines from state-owned Sinopharm to Malaysia, and that we would be carrying out trials with the Medical Research and Ethics Committee to finalise the stringent criteria.

Shipments of Beijing-based Sinovac’s vaccine, CoronaVac, have arrived in Indonesia in preparation for a mass vaccination campaign, with another 1.8 million doses due by next month.

Sinovac’s edge is that it can be stored in a standard refrigerator at 2-8 degrees Celsius, like Oxford’s AstraZeneca, while Moderna’s vaccine needs to be stored at -20 C and Pfizer’s at -70 C.

That means the Chinese and UK vaccines are more practical for developing countries like Malaysia. Otherwise, we’d have issues storing large amounts of vaccine at extremely low temperatures because special storage facilities will be needed, which seems almost out of the question for rural areas.

Then, there’s the halal issue. The concerns among Muslims about the shots containing substances forbidden by Islam is understandable as the same issue was also brought up by Muslims in Indonesia.

But here are some simple medical rules – the Malaysian government does not register a medicine based on halal or non-halal status. No medicine carries a Jakim sticker that says halal certified.

Malaysia has inked a deal with Pfizer to supply 12.8 million doses of its Covid-19 vaccine for 20% of the population. It has also reportedly entered a pact with Covax Facility, the global Covid-19 vaccine development platform, to cover another 10% of the population.

This is a life and death situation. No one needs to be an Islamic theology expert to know what Islam says about emergency cases relating to starvation or medical treatment. Perlis Mufti Datuk Mohd Asri Zainul Abidin has reportedly said that “even if there is an ingredient which is not permissible, the chemical transformation process will make it clean and halal.”

The Special Muzakarah Committee of the National Council for Malaysian Islamic Affairs met on Dec 3 to discuss whether the vaccine can be administered to Muslims.

Religious Affairs Minister Datuk Seri Zulkifli Mohamed Al-Bakri said the decision would be announced by the King.

Given the grounds to this concern, this is certainly the right course of action, especially in curtailing it from becoming both religious and political issues, or from companies exploiting the matter for commercial reasons by making all sorts of claims.

As someone privileged to have met Zulkifli, who tested positive himself, I can vouch that he is one of the most rational and practical Islamic scholars.

The United Arab Emirates, a Muslim country, has accepted the China-made Sinopharm and Indonesia, the world’s most populous Muslim country, is ready to take the vaccine from China, too. And Saudi Arabia has embraced Pfizer’s vaccine.

The end of Covid-19 is in sight for sure. The fact that Malaysia is already talking of vaccination and testing approaches, means we’re already making practical preparations.

Last week, I spoke to Datuk Zulkarnain Md Eusope, the chief executive officer of Pharmaniaga Bhd, the company tasked with bottling and transporting the Covid-19 vaccine for Malaysia.

The company is already preparing for the distribution of these vaccines and is just waiting for the government’s approval for the big day.

Zulkarnain is an excited man and rattled off details of what and how Pharmaniaga has readied itself to be part of history and saving lives.

For most Malaysians, 2020 has been a horrible year of Covid-19 and squabbling politicians.

What a toxic combination. For sure, we can’t wait to welcome 2021.

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Preparations in place for vaccine rollout

Research now in the final stages

From page 15 BEIJING: Research and development of coronavirus vaccines in China are at the final stages, with preparations in place for their mass production, said the head of the country’s Covid19 vaccine development task force.

There are five domestically developed vaccines under a phase-3 clinical trial, the final stage before attaining approval from the authorities, making China a leading country in Covid-19 vaccine development, said Zheng Zhongwei, who is also director of the National Health Commission’s development centre for medical science and technology.

Despite taking a leading role in Covid-19 vaccine research and development, China does not rush to compete in the field, Zheng told Xinhua on Wednesday.

Vaccines should be evaluated by criteria such as safety, effectiveness, accessibility and affordability before they are approved for market availability, he said, adding that China is being prepared for the mass production of vaccines. Researchers in China have been racing to develop Covid-19 vaccines. A total of 15 vaccines using five different technologies are under clinical trials in China.

Of them, five are undergoing phase-3 clinical trials in countries including the United Arab Emirates, Brazil and Pakistan, as domestic trials involving many volunteers are not practical due to the effective control and prevention of the epidemic on the Chinese mainland.- ANN/THE STAR

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Inactivated COVID-19 vaccine CoronaVac produced by Chinese vaccine developer Sinovac Photo: Courtesy of Sinovac

 Chinese vice premier Sun Chunlan stressed a scientific and rigorous preparation is required for the mass production of Chinese-developed COVID-19 vaccines during an inspection tour of vaccine production lines of some leading manufacturers in Beijing on Wednesday, the same day the UK became the first Western country to approve a coronavirus vaccine for widespread use.

Sun and State Councilor Wang Yong visited the National Institute for Food and Drug Control, and two leading vaccine producers Sinovac, National Vaccine & Serum Institute under Sinopharm in Beijing, the Xinhua News Agency reported late Wednesday.

The visit was seen as a prelude for the vaccine coming to market in a rigorous and scientific manner. Russia and the UK announced on Wednesday they will start mass vaccinations against the coronavirus next week.

Sun and Wang learned about COVID-19 vaccine research, visited production plants and checked preparation work, and fully affirmed the achievements of the vaccine developers.

Fourteen vaccines using five technology methods are in clinical trials and five vaccines are undergoing phase Ⅲ clinical trials. Emergency use, production preparation and other work are proceeding in an orderly manner.

Sun called for scientific and rigorous phase Ⅲ clinical trials to carry out review and approval work in strict accordance with laws, regulations and internationally recognized technical standards to ensure the safety and effectiveness.

She required Chinese companies prepare for mass production, strictly comply with laws, regulations, procedures and requirements on quality supervision and biosafety, improve the traceability system for vaccines, punish illegal activities for creating a favorable market environment.

Sun said it's necessary to formulate a vaccination distribution plan before the vaccines are made available to the public. The emergency use of the vaccine in high-risk groups, such as port workers and front-line supervisors, will be completed by the end of 2020, she said.

The UK's approval of Pfizer's coronavirus vaccine on Wednesday paved the way for widespread uses of the vaccine. The first doses are already on their way to the UK, with 800,000 due to arrive in the coming days, Pfizer said.

Analysts said the UK and Russia's quick approval for widespread use of vaccine is mainly in response to new outbreaks that may get worse during the coming winter.

China is very likely to introduce its first officially approved vaccine for mass use in December, but whether it would be approved only for limited use is still under discussion, a Beijing-based immunological professor who asks not to be named told the Global Times.

The first vaccines to get approval are likely the inactivated vaccine candidates from either Sinovac or state-owned Sinopharm, said the professor, noting that other frontrunner candidates such as recombinant adenovirus vector vaccine would be slightly behind or approved for emergency use first.

The Global Times learned from the Sinovac's Brazilian partner Butantan Institute which is carrying out the phase Ⅲ clinical trials of the inactivated vaccine CoronaVac that the data from the trials have been sent to the Brazilian National Health Surveillance Agency. Sinovac told the Global Times that analysis of the clinical data will take some time.

Compared to China, vaccines are more urgently needed in the West, said a Shanghai-based vaccine expert. "The epidemic battle left many Americans desperate, let's hope President-elect Joe Biden will take human rights seriously and not follow in Trump's footsteps."

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