- As of end-January, Singapore has administered 12,755,259 doses of the Pfizer-BioNTech/Comirnaty and Moderna/Spikevax mRNA vaccines, out of which 15,655 suspected adverse events reports were received.
- The most common side effects included allergic reactions such as rash or swelling of eyelids, face and lips, dizziness, shortness of breath and fever.
- There were also 820 serious adverse events reported, including 88 cases of anaphylaxis and other reactions such as rheumatoid arthritis, severe skin reactions and low platelets and blood clots.
- "HSA has assessed that the reporting rate of AEs and serious AEs of 0.12 per cent and 0.006 per cent of administered doses, respectively have remained stable since the roll-out of the COVID-19 vaccines and the overall benefits of the COVID-19 vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known AEs," said the authority.
- As of Jan 31, a total of 369,083 doses of the Sinovac-CoronaVac vaccine have been administered, with 299 suspected adverse events and 22 serious adverse events reported.
- For Sinopharm, 89,350 doses have been administered, with 41 suspected adverse events and six serious adverse events reported.
- "The type and number of reports received for different COVID-19 vaccines are not directly comparable as the vaccines have been used in the vaccination programme for different durations of time," said HSA.
- Since the booster programme was rolled out on Sep 15, a total of 3,194,494 have received these jabs as of Jan 31, said HSA.
- In this category, there were 553 adverse events reports (0.03 per cent of doses administered) associated with the use of the PfizerBioNTech/Comirnaty vaccine and 289 such reports (0.03 per cent of doses administered) with the Moderna/Spikevax vaccine.
- There were also 73 serious adverse event reports (0.002 per cent of administered doses), of which 15 cases were myocarditis and pericarditis - inflammation of the heart muscles and outer lining of the heart respectively.
- HSA said that it is closely monitoring several adverse events of special interest, including anaphylaxis, myocarditis, pericarditis and cerebral venous thrombosis.
- So far, the incidence rate of anaphylaxis reported locally with the vaccines has remained "low and stable" at about 0.89 per 100,000 doses administered, said HSA.
- Of the 88 cases of anaphylaxis reported with the mRNA vaccines, all the patients recovered after medical treatment, said the authority.
- It added that the number of cases of anaphylaxis associated with the second dose was lower than with the first dose of mRNA vaccines. To date, HSA has not received any cases of anaphylaxis associated with the booster dose.
- For myocarditis and pericarditis, HSA said that it has as of end-January received 115 reports following the administration of mRNA vaccines. These cases happen more frequently in younger males below 30 years old, and more often with the second dose, said HSA.
- One case of myocarditis with Sinovac-Coronavac vaccine has also been reported.
- "Most cases are mild, with individuals reported to have recovered or are recovering," said the authority.
- "It should be noted that COVID-19 infection is also known to be associated with myocarditis," HSA added.
- There have been rare cases of cerebral venous thrombosis (CVT), or blood clots occurring in the veins of the brain, reported with the mRNA vaccines.
- As of end-January, HSA has received 13 suspected reports of cerebral venous thrombosis with such vaccines.
- "Vaccines are the best way to protect people from COVID-19 and have already saved many lives," said HSA.
- "HSA’s current assessment is that the overall benefits of the Pfizer-BioNTech/Comirnaty, Moderna/Spikevax and Sinovac-CoronaVac COVID-19 vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known adverse events," it added.
- Pfizer-BioNTech
- Moderna
- Johnson & Johnson
- Oxford-AstraZeneca
- Novavax
- Pfizer-BioNTech mRNA vaccine
- Moderna mRNA vaccine
- Johnson & Johnson (J&J) adenovirus vector vaccine
- Pfizer-BioNTech
- Moderna
- Johnson & Johnson
Singapore has ordered the Pfizer-BioNTech, Moderna and Sinovac vaccines as the first three of its portfolio in the fight against the coronavirus pandemic.
Across Asia, Chinese vaccines have played a crucial role in immunising people against Covid-19, with millions receiving either a Sinovac or Sinopharm jab. But in recent weeks, concerns have grown about their efficacy. Now, some Asian countries which made Chinese vaccines a key plank in their immunisation programmes have announced they will use other jabs. The move has raised questions, not only about whether China's vaccines can be trusted, but also about its attempts at vaccine diplomacy in Asia.
Last week, Thailand announced it was changing its vaccine policy - instead of receiving two Sinovac shots, residents will now get a mix of Sinovac and AstraZeneca. Healthcare workers who are already fully vaccinated with Sinovac will also get a different jab as a booster shot.
Indonesia announced a similar move the previous week, saying it was giving Moderna booster shots to healthcare workers immunised with Sinovac. The decisions followed reports that hundreds of fully vaccinated healthcare workers had caught Covid, with some of them - two in Thailand and 30 in Indonesia - dying.
- Anyone who got the two-dose Moderna vaccine received either a Moderna, Pfizer or J&J booster.
- Those who got the two-dose Pfizer vaccine got either the Pfizer, Moderna or J&J booster.
- Anyone who got the one-shot J&J vaccine got another J&J shot, or a Moderna or Pfizer booster.
- Pfizer shot with a Moderna booster.
- Moderna’s two-dose vaccine with Pfizer’s booster.
Scientific teams around the world have developed successful Covid-19 vaccines in incredibly short order. In a feat that even a couple of years ago would have seemed completely out of reach, vaccines to protect against the new disease were being used before the first anniversary of the disclosure that a new threat existed. This is truly extraordinary.
- Pfizer-BioNTech (Type: mRNA) - The Pfizer-BioNTech COVID-19 vaccine was sent to the FDA for possible Emergency Use Authorization (EUA) on Friday, November 20 and authorized on December 11. It is an mRNA vaccine that codes for the virus’s spike protein and is encapsulated in a lipid nanoparticle. Once injected, the cells churn out the spike protein, triggering the body’s immune system to recognize the virus. In Phase III trials, it demonstrated 95% efficacy. The Pfizer-BioNTech vaccine requires storage at about -94 degrees F, which requires specialized freezers. Now authorized in the U.S. for adolescents 12 to 15 years of age.
- Moderna (Type: mRNA) - On November 16, Moderna issued a preliminary data readout out of its COVID-19 vaccine, suggesting an efficacy rate of 94.5%. It was authorized by the FDA on December 19. Like the Pfizer-BioNTech vaccine, it is an mRNA vaccine. Unlike that vaccine, however, the Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F.
- AstraZeneca (Type: Adenovirus-based) - On November 23, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%. The vaccine was effective at preventing COVID-19, with no hospitalizations or severe cases in people receiving it. There were a total of 131 COVID-19 positive cases in the interim analysis group. One dosing regimen was given at a half dose and demonstrated 90% efficacy, followed by a full dose at least one month apart. Another dosing regimen demonstrated 62% efficacy when given two full doses at least one month apart. The combined analysis showed average efficacy of 70%. The AstraZeneca vaccine can be stored, transported and handled at normal refrigerated conditions, about 36-46 degrees F for at least six months and administered within existing healthcare settings.
- Johnson & Johnson (Type: Adenovirus-based) - Johnson & Johnson announced on November 15 that it initiated a second global Phase III trial of its Janssen COVID-19 vaccine. They expect to enroll up to 60,000 volunteers worldwide. Whereas all of the other three vaccine candidates require two doses about 28 days apart, the J&J vaccine only requires a single dose. Interim results from its Phase I/IIa trial demonstrated a single dose of the vaccine induced a robust immune response and was generally well-tolerated. The ENSEMBLE 2 study evaluated a two-dose regimen as well.
- Russia’s Sputnik V Vaccine (Type: Adenovirus-based) - Around November 11, Russia’s National Research Center for Epidemiology and Microbiology, which Russia authorized for use in August—ahead of even beginning a Phase III trial—claimed had an efficacy rate of 92% after the second dose. It was based on a first interim analysis 21 days after the first injection during the ongoing Phase III study. On November 24, the organization claimed 95% efficacy based on new preliminary data. On December 14, 2020, they reported efficacy of 91.4%. It also offered to share one of its two human adenoviral vectors with AstraZeneca to increase the efficacy of the AstraZeneca vaccine.
- Sinovac Biotech (Type: Inactivated SARS-CoV-2 virus) - On January 13, 2021, China-based Sinovac Biotech reported that its COVID-19 vaccine had a 50.38% efficacy in late-stage clinical trials in Brazil. The company’s clinical trials are demonstrating dramatically varying efficacy rates. In Indonesia, a local trial demonstrated an efficacy rate of 65%, but the trial had only 1,620 participants. Turkey reported an efficacy rate of 91.25% in December 2020. Another trial in Brazil run by a local partner, Butantan Institute, reported last week a 78% efficacy rate in mild cases while 100% against severe and moderate infections. It is an inactivated vaccine that uses inactivated SARS-CoV-2 viruses.
- Novavax (Type: Protein-based vaccine) - On January 28, 2021, Novavax announced that its COVID-19 vaccine, NVX-CoV2373, hit the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the UK. The vaccine is a protein-based COVID-19 vaccine candidate. It also has data from the South Africa Phase IIb trial and several Phase I, II and III trials. It has demonstrated high clinical efficacy against the UK and South Africa variants as well.
- CanSino Biologics (Type: Viral vector) - CanSino Biologics vaccine was co-developed with the Chinese military. It has an efficacy rate of 65.7% at preventing symptomatic cases. This is based on a multi-country analysis first posted on Twitter by Faisal Sultan, Pakistan’s health adviser, on February 8, 2021. The Phase III trial includes 30,000 participants and demonstrated 90.98% efficacy in preventing severe disease. It only requires a single shot. It has agreed to supply 35 million doses to Mexico and is in talks with Malaysia for 3.5 million shots. Pakistan is running one of the largest trials, and has contracted for 20 million shots. It is also working with the WHO for approval for the vaccine through the Covax program. It is also planning a trial with Russia to determine if swapping the second dose of Russia’s Sputnik V vaccine with Can Sino would produce the same or better protection.
- Bharat Biotech (Type: Inactivated SARS-CoV-2 virus) - On April 22, 2021, India’s Bharat Biotech reported interim data from the Phase III trial of its COVID-19 vaccine COVAXIN, which demonstrated a 100% efficacy against severe infection. The vaccine was developed with seed strains from the Indian Council of Medical Research’s (ICMR) National Institute of Virology. It is a highly purified and inactivated vaccine. A second interim analysis suggested a 78% efficacy against mild, moderate and severe disease, and 70% efficacy against asymptomatic disease. Does not require sub-zero storage, no reconstitution requirement, and ready to use liquid in multi-dose vials, stable at 2-8 degrees C.
- MODERNA AND PFIZER-BIONTECH - The Moderna vaccine is currently available at 11 of the 38 vaccination centres in Singapore. All the other centres are supplied with the Pfizer-BioNTech vaccine. Currently, both Moderna and Pfizer-BioNTech are very similar. They both use the new messenger RNA technology which injects parts of the virus's genetic material into the body. This then teaches cells to create a protein that will trigger an immune response. This will allow your body to produce antibodies to fight the virus. The reported side effects of both vaccines are also very similar with people typically reporting pain or swelling at the injection site, fatigue, headaches, muscle aches, fever, chills, nausea and joint pains.
- SINOVAC - Sinovac, on the other hand, is the latest vaccine to enter the market. Currently, there are 24 private clinics islandwide that have been selected to administer it. A single dose will cost you between $10 to $25 and you will need two doses. "As these vaccines are being provided to the providers at no cost, individuals should take note that the providers should not charge them for the vaccine cost. There should not be any additional costs (beyond the vaccination administration fees listed) charged by these providers," the Ministry Of Health (MOH) said. However, do note that because Sinovac is not part of the national vaccine programme, it will not be covered under the Vaccine Injury Financial Assistance Programme for Covid-19 Vaccination. Additionally, recipients of the Sinovac Covid-19 vaccine will not be exempted from pre-event testing according to MOH.
- The Sinovac vaccine uses an inactivated form of COVID-19 virus, where the viral particles are killed so that it cannot replicate. However, the surface spike protein of the virus particle is kept intact to trigger the body’s immune system to create antibodies to protect against the live virus in the event that the person is infected with COVID-19. Inactivated viruses are a tried and tested form of vaccine technology and have been traditionally used to create vaccines over the past century. Examples of inactivated virus vaccines include the flu, polio and hepatitis A vaccines.
- In contrast, the Pfizer-BioNTech and Moderna vaccines use a different form of vaccine technology. They are Messenger RNA vaccines – also known as mRNA vaccines – which are a new type of vaccine. Both vaccines are the first vaccines approved for use in humans using the mRNA technology. Instead of introducing an inactivated form of the COVID-19 virus into our bodies, mRNA vaccines give instructions to our cells to make a harmless spike protein which is found on the surface of COVID-19 virus particles. When this happens, our immune systems create antibodies that are used to protect against the live virus in the event that there is an infection.
- How does the Sinovac vaccine work? The Beijing-based biopharmaceutical company Sinovac is behind the CoronaVac, an inactivated vaccine. It works by using killed viral particles to expose the body's immune system to the virus without risking a serious disease response.
- By comparison the Moderna and Pfizer vaccines being developed in the West are mRNA vaccines. This means part of the coronavirus' genetic code is injected into the body, triggering the body to begin making viral proteins, but not the whole virus, which is enough to train the immune system to attack.
- PFIZER-BIONTECH (Type: mRNA) - The COVID-19 vaccine developed by US pharmaceutical giant Pfizer and Germany’s BioNTech was the first COVID-19 vaccine to be approved by the US FDA for emergency use. How it works: The Pfizer-BioNTech vaccine uses messenger RNA (mRNA) technology. mRNA vaccines teach our cells to make a protein that triggers an immune response inside our bodies. This is different from traditional vaccines which put a weakened or inactivated germ into our bodies.
- MODERNA (Type: mRNA) - The initial results from Moderna's vaccine were described a month ago by the US' leading expert on infectious diseases Anthony Fauci as "stunningly impressive". How it works: Just like the Pfizer-BioNTech vaccine, the Moderna vaccine uses mRNA technology.
- SINOVAC (Type: Inactivated SARS-CoV-2 virus) - Developed by China's Sinovac Biotech, the vaccine, known as CoronaVac, is currently undergoing phase 3 clinical trials in places such as Brazil and Indonesia. How it works: Sinovac's vaccine uses inactivated vaccine technology, which utilises virus particles that have been killed to stimulate our bodies to produce an immune response. This vaccine is similar to the flu vaccine.
- Claim #1: mRNA vaccines are ineffective against COVID-19. Both the Pfizer-BioNTech and Moderna mRNA vaccines continue to be highly efficacious, with efficacy rate at around 90%. This has been established by the Expert Committee on COVID-19 Vaccination (EC19V) based on their continual review of global and local data. These two vaccines are also especially effective in protecting against severe COVID-19 disease and hospitalisation.
- Claim #2: mRNA vaccines are useless in protecting us against COVID-19 mutations. The mRNA vaccines are effective in protecting us against key VOCs, including the B16172 or “delta” variant. Studies in the UK demonstrated that two doses of the Pfizer-BioNTech mRNA vaccine can provide around 80% protection against symptomatic COVID-19 infection with the delta variant. While further studies are required before drawing definitive conclusions, the available data globally indicates that substantial protection is preserved. The asymptomatic to mild infections detected locally with the delta variant in vaccinated persons is consistent with the global evidence that mRNA vaccines provides protection against symptomatic and severe disease.
- Claim #3 - mRNA vaccines are not safe. The mRNA vaccines have gone through rigorous evaluation by HSA and EC19V and have been assessed to be safe for use. They had been authorised by HSA under the Pandemic Special Access Route (PSAR) and included as part of our COVID-19 national vaccination programme. Like all vaccines, people who receive the COVID-19 vaccines may experience common side effects. Most of the side effects are mild or moderate, and usually get better within a few days. In very rare instances, persons may experience serious side effects, such as a severe allergic reaction to the mRNA vaccine (e.g., anaphylaxis). The currently available data also suggests that there may be a very small risk of myocarditis and pericarditis after the second dose of an mRNA vaccine, particularly in young men. However, these serious side effects are rare, and risks are mitigated with careful monitoring of symptoms and seeking medical attention early. Overall, the benefits of receiving the mRNA COVID-19 vaccines, i.e., reduction in COVID-19 infections and severe complications even if infected, continue to outweigh the risks of vaccination. It is strongly recommended that medically eligible persons are vaccinated with them.
- Claim #4 - Inactivated virus vaccines, like Sinovac, can protect us better than mRNA. Sinovac, an inactivated virus vaccine, has shown variable protection across multiple international studies. The most complete analysis of the vaccine showed a vaccine efficacy of 51%. The protection of Sinovac against newer variants, such as the delta variant, and under real-world conditions remains unknown. On the other hand, global and local data has shown that the PSAR-authorised mRNA vaccines are able to protect against COVID-19 and its variants by reducing the severity of symptoms. The Sinovac vaccine has yet to meet the requirements for PSAR authorisation. HSA is currently still waiting for the additional safety and quality data from Sinovac for evaluation.
- Claim #5 – Children should be given Sinovac since the vaccine technology has proven to be safe. WHO does not recommend the use of Sinovac in persons below age 18 years even though it is put under its Emergency Use Listing (EUL) Procedure. As such, this is currently not an option for children and adolescents globally nor in Singapore under the Special Access Route (SAR). On 18 May 2021, HSA endorsed the use of Pfizer-BioNTech mRNA vaccine in children between 12 to 15 years old. This decision was made after the careful assessment of the safety and efficacy data from the Pfizer-BioNTech vaccine for persons of this age group.
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