Covid-19 Vaccines: In God We Trust, All Else We Audit — Dr Musa Mohd Nordin

We must have ready access to a complete portfolio of vaccines to enhance our chances of attaining herd immunity.

The Covid-19 vaccines have been under public scrutiny since the mRNA vaccines from Pfizer-BioNTech was first granted early and limited use by the British Medicines and Healthcare Products Regulatory Agency (MHRA) on 2 December 2020.

And nine days later, an Emergency Use Authorization (EUA) was issued by the US Food and Drug Administration (FDA) for the Pfizer-BioNTech mRNA vaccine.

The Pfizer-BioNTech mRNA vaccine has since been authorised for use in 61 countries, including Malaysia. It is also the first Covid-19 vaccine to be given emergency use validation by the World Health Organisation (WHO) on December 30, 2020, which also emphasised the need for global equitable access to COVID-19 vaccines.

Approximately 148 million doses have been administered globally. Israel and the United Arab Emirates leads the pack with 78 per cent and 53 per cent of its population immunised with the Pfizer and Chinese vaccines respectively.

Thus far, all the vaccines used have proven to be very effective in preventing Covid-19 cases in Category Three to Five, which often requires patients to be hospitalised and has been responsible for 2.4 million deaths as at February 17.

The Phase III Vaccine Trials have shown vaccine efficacy (VE) in the range of 85-100 per cent protection against Covid-19.

Israel was among the first countries to undertake a mass rollout of the vaccines in December 2020. By the first week of February 2021, 40 per cent of eligible Israelis had received the first dose of one of the two mRNA vaccines. 75 per cent of those over 60 years old had received both doses of their vaccines.

Maccabi, Israel’s second-largest health care provider has compared the infection rates of immunised and non-immunised Israelis. 66 (0.03 per cent) out of a group of 248,000 vaccinated persons developed mild symptoms and did not require hospital care.

In contrast, 8,250 (0.92 per cent) out of 900,000 unvaccinated persons were infected by Covid-19, which is 30 times more than people in the vaccinated group.

The estimated Vaccine Efficacy (VE) was 92 per cent, similar to the 95 per cent in the Pfizer and Moderna Phase III Trials.

In Maccabi’s sample group of 50,777 people over the age of 60 who received two doses of the vaccine, a 60 per cent decrease in the  number of new infections and hospitalisations was reported.

Israel is presently undergoing its third lockdown which began in late December 2020. As of February 12, they have reported 734,575 cases with 5,441 deaths (0.74 per cent). Researchers have suggested that the fall in cases and hospitalisations are due to the effects of the vaccines and not just the lockdowns.

Israel was also experiencing the highly contagious B.1.1.7 Kent strain, which was filling up hospital beds. The world has also experienced the emergence of the highly transmissible B.1.351 strain from South Africa and the P.1 variant from Brazil.

These SARS-CoV-2 mutations have rendered some of the vaccines less efficacious. The VE of the Janssen, Novavax, and Astra-Zeneca vaccines are 57%, 50% and 10% against the South African strain respectively. South Africa has since stopped the roll out of the AstraZeneca vaccine. (6) (Diagram IIIA-C))

Novavax had a VE of 95.6 per cent against the original Covid-19 strain and 85.6 per cent against the UK variant strain.

The presence of these very contagious variants in the community is very worrying and challenging to Malaysia’s vaccine programme. We must ensure very strict border controls to prevent the entry of these strains into the country.

The shortened three-day quarantine period of ministers is a policy mistake. They are known to be Covid-19 super-spreaders since the Sabah state election. Having them move about in the community so soon after their travels abroad has the potential of spreading very contagious SARS-CoV-2 mutations among the general population. This can increase the number of cases, overwhelm our presently stretched health care capacity, and endanger the lives of the rakyat.

Similarly, the Malaysia-Indonesia travel bubble recently negotiated by the Prime Minister is not a good idea either. Indonesia, despite the introduction of the Sinovac vaccination programme, is a potential epicentre of the super-spreader mutations, when taking into consideration their 1.2 million cases and 32,000 deaths. Their positive rates is still very high at 28.5 per cent, as of February 7.

Very close surveillance by the Institute for Medical Research, Malaysia (IMR) has detected a second Kent strain in Malaysia. It is vital that we stem the spread of such transmissible strains, or we will render our vaccines less effective in protecting our population.

The more than 85 per cent efficacy by all vaccines against the original SARS-CoV-2 strain is most welcome news. It means that less victims are admitted, there is less utilisation of ICUs and ventilator beds, lesser deaths and less strain on health care services.

The other property of the vaccine that is currently being investigated is its ability to prevent the transmission of infections. Early studies are indicating that the AstraZeneca vaccine is able to decrease the spread by 67 per cent.

In the Moderna trial, volunteers are swabbed during their baseline shots and before their second dose. 39 (0.3 per cent) in the placebo group and 15 (0.1 per cent) in the vaccine group became positive prior to the second dose (28 days) after an initial negative swab at baseline and remained asymptomatic.

This suggests that even after the first dose, there is a 60 per cent reduction of asymptomatic carriage. We look forward to follow-up reports on these patients to examine the reduction or elimination of the SARS-CoV-2 strain in the nasopharynx following immunisation.

Children under 16 years, those with certain pre-existing morbidities, and those who choose not to receive the vaccines will benefit from the indirect protection provided by the vaccines which reduces the transmission of the coronavirus.

Some vaccine manufacturers are already beginning to design booster vaccine shots that would protect against these new variants. Others are developing poly-valent vaccines to deal with the many SARS-CoV-2 mutations.

For a start, the National Pharmaceutical Regulatory Agency (NPRA) must very quickly license Moderna, Sputnik V and AstraZeneca for Emergency Use Authorisation (EUA) since they have been published in peer reviewed scientific journals. And we suspect Sinovac, Sinopharm, Johnson & Johnson and Novavax have submitted their brief documents for consideration.

This is very critical in order to ensure we have ready access to a complete portfolio of vaccines to enhance our chances of attaining herd immunity with multiple vaccines rapidly.

As it is, Covid-19 vaccines are very difficult to come by and nations are scrambling to lay their hands on them. Even vaccine manufacturers are competing to acquire raw materials to ramp up their manufacturing capacity.

We have quite a bit of catching up to do. Singapore, Indonesia, Nepal, Bangladesh and Myanmar, just to mention a few, have advanced ahead of us. Singapore is expecting to complete its Covid-19 immunisation programme by December 2021.

If EUA is granted by the NPRA, private hospitals may be able to procure the vaccines and provide them to their paying clients. Our open letter to the Prime Minister urged the government to facilitate the licensing process and to cap the selling price of the vaccines (and PCR and RTK-Ag kits).

This is essential in order to ensure that they are affordable for the paying public and helps to accelerate the national agenda to achieve herd immunity.

There are reliable sources claiming that certain quarters are quietly providing the Chinese vaccines to select members of the public. These Chinese vaccines have yet to be licensed by the NPRA.

The clandestine supply of these unauthorised vaccines must be stopped and the responsible agencies, namely the Ministry of Health and the National Vaccination Council.

  • This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.

You may also like