A complete guide on vaccines approved by WHO and EMA

On one hand, the world inches closer to 100 per cent vaccination each passing day, while on the other, questions about the safety and efficacy of Covid vaccines are being raised. In such a climate, approvals from international health regulatory bodies like the WHO and EMA have become pivotal.

Let’s take a closer look at which vaccines have been approved by the World Health Organisation and European Medical Agency so far.

Significance of WHO and EMA-approved vaccine lists

The WHO’s EUL listing acts as a benchmark for the other countries, including the US, the UK, the UAE, Thailand  and more. Hundreds of colleges in the US have also been asking international students to get immunized with WHO-approved vaccines.

Many countries have started regarding those who received vaccines not approved by the WHO as unvaccinated. Going forward, if vaccine passports rely on WHO-approved vaccines exclusively, travellers who have received other vaccines will be left at an obvious disadvantage as they may not be granted entry to certain countries.

Meanwhile, EU has explicitly said that the EU Covid-19 vaccination passport will be issued singularly to those who have received any of the vaccines approved by the EMA.

It was also announced that soon, member states of the EU may start accepting non-essential travellers from the rest of the world, provided they have received both doses of an EMA/WHO-approved vaccine.

Which vaccines are approved by the WHO so far?

Pfizer/BioNTech: Comirnaty

The BNT162b2 is a messenger Ribonucleic Acid (mRNA) vaccine meaning that it carries genetic instructions that help the recipient’s cells to produce protein pieces that trigger immune system response.

On Dec 31, 2020, Comirnaty became the first vaccine to get a nod from the WHO. It is being distributed in almost 90 countries across the globe, including the USA, the UK, the UAE, Saudi Arabia, Canada and Australia.

Oxford/AstraZeneca: Vaxzevria

The ChAdOx1 Covid-19 vaccine is based on the virus’s genetic instructions for building the spike protein, which are stored using double-stranded DNA.

WHO approved three versions of the AstraZeneca vaccine so far: one in the EU, one produced by Serum Institute of India (SII) and the third by SKBio (Republic of Korea) on Feb 15, 2021 for emergency use as well as COVAX supply.

AstraZeneca is the highest distributed vaccine in the world, with 115 countries having recognized it. Covishield has been authorized by around 45 countries, including India, Egypt, Maldives, and others primarily in Asia and Africa.

Johnson & Johnson: Ad26.COV2.S

The Janssen vaccine leverages the AdVac vaccine platform to engineer a common cold virus to carry genetic instructions into the arm cells where they construct a replica of the coronavirus spike, triggering the immune system.

The one-off vaccine was listed by the WHO for emergency use and COVAX roll-out on March 12, 2021. Around 50 countries, including Bahrain, South Africa, the USA and Kuwait have included the Janssen jabs in their immunization programs.

Moderna: mRNA-1273

The Moderna vaccine primarily works by injecting a fraction of the Covid-19 virus’ genetic code into the body. This will trigger the body’s immune response, therefore, creating antibodies capable of fighting the virus.

The WHO authorized Moderna for emergency use on April 30, 2021. The American vaccine has received approval in 53 countries, including the USA, France, Germany, Israel, Qatar, and Singapore.

Sinopharm: BBIBP-CorV

Sinopharm relies on the older but tested technology, which involves taking an inactivated form of the virus to stimulate the body’s immune response.

The Chinese pharmaceutical got the green signal from the WHO on May 7, 2021. So far, 53 countries, including Argentina, China, Lebanon, Pakistan, and Vietnam.

Sinovac: CoronaVac

Sinovac, too, is an inactivated virus vaccine, which means it is made from viral particles produced in a lab, which are then inactivated so they can’t infect with Covid-19.

It was approved by the WHO on June 1, 2021 and is currently being used in over 30 Asian and South American countries including Brazil, Indonesia, the Philippines and Thailand.

WHO guide of approval

The World Health Organisation’s Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

In the case of vaccines, the following criteria must be met:

• The disease for which the product is intended is serious or immediately life-threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for a EUL assessment
• Existing products have not been successful in eradicating the disease or preventing outbreaks
• The product is manufactured in compliance with current Good Manufacturing Practices (GMP)
• The applicant undertakes to complete the development of the product and apply for WHO prequalification once the product is licensed

For Covid-19 vaccines, the UN’s health branch has set the bar for minimum efficacy at 50per cent in its considerations for evaluation of Covid-19 vaccines.

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Which vaccines are approved by the EMA so far?

Pfizer/BioNTech: Comirnaty

The BNT162b2 is a messenger Ribonucleic Acid (mRNA) vaccine meaning that it carries genetic instructions that help the recipient’s cells to produce protein pieces that trigger immune system response.

The EMA granted Pfizer a conditional marketing authorization on Dec 12, 2020.

Moderna: mRNA-1273

The Moderna vaccine primarily works by injecting a fraction of the Covid-19 virus’ genetic code into the body. This will trigger the body’s immune response, therefore, creating antibodies capable of fighting the virus.

The EMA granted Pfizer a conditional marketing authorization on Jan 6, 2021.

Oxford/AstraZeneca: Vaxzevria

The ChAdOx1 Covid-19 vaccine is based on the virus’s genetic instructions for building the spike protein, which are stored using double-stranded DNA.

The EMA granted Pfizer a conditional marketing authorisation on Jan 29, 2021.

Johnson & Johnson: Ad26.COV2.S

The Janssen vaccine leverages the AdVac vaccine platform to engineer a common cold virus to carry genetic instructions into the arm cells where they construct a replica of the coronavirus spike, triggering the immune system.

The EMA granted Pfizer a conditional marketing authorisation on March 11, 2021.

EMA guide of approval

During the Covid-19 pandemic, the European Medical Agency (EMA) is using the conditional marketing authorisation procedure for expediting the approval of safe and effective Covid vaccines in the European Union.

The safety monitoring of vaccines involves a number of routine activities ranging from:

• Assessing the way risks associated with the vaccine will be managed and monitored once it is authorised
• Continuously monitoring suspected side effects reported by patients and healthcare professionals, identified in new clinical studies or reported in scientific publications
• Regularly assessing reports submitted by the company holding the marketing authorisation on the benefit-risk balance of the vaccine in real life
• Assessing the design and results of post-authorisation safety studies which were required at the time of authorisation

Vaccines waiting to be approved

The process for submitting applications for WHO and EMA approvals is quite extensive, requiring several legal and technical formalities. While some vaccines have already received their sanctions, a few others are still in the process.

WHO

The following are some of the vaccines at different stages of pre-submission, dossier review, assessment, and decision:

• Gamaleya National Centre of Epidemiology and Microbiology’s “Sputnik V”
• Novavax CZ AS’ “CoV2373”
• Bharat Biotech’s “Covaxin”
• Sinopharm’s “Vero Cell”
• CanSino Bio’s “Ad5-nCov”
• CureVac AG’s “CVnCoV”

Beneficiaries of Covaxin in India have raised serious concerns about their travel plans being jeopardised if the vaccine is not approved by the WHO.

To remedy this, Bharat Biotech has applied to the organisation and had a pre-submission meeting on June 23. The company expects WHO’s EUL nod between July and September this year.

On similar lines, Sputnik V expects its approval within the next two months as well, as there have been “no critical remarks for now at all”.

EMA

The EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a rolling review of the clinical trial data of the vaccines. Only after it decides that enough evidence is available can the developer apply for marketing authorisation.

The following four vaccines are under review:

• Sinovac Life Sciences Co.’s “CoronaVac”
• CureVac AG’s “CVnCoV”
• Novavax CZ AS’ “CoV2373”
• Gamaleya National Centre of Epidemiology and Microbiology’s “Sputnik V”

Sputnik V will probably have to wait longer for approval. The Russian institute missed its deadline on June 10 for submission of data, pushing back the EMA’s decision at least until September.

Country-level approved vaccine lists

While the approvals from WHO and EMA certainly act as a yardstick, the ultimate decision of which vaccines to accept is up to the countries.

Some countries have reserved entry to only those foreign travellers who have received vaccines approved by them. Let’s take a look.

UAE

Dubai’s Supreme Committee of Crisis and Disaster Management announced that, with effect from June 23, only vaccinated passengers from India, South Africa and Nigeria can fly to Dubai. The stipulation is that they must have received one of the vaccines approved in the UAE:

• Sinopharm
• Pfizer/BioNTech
• Oxford/AstraZeneca, i.e Covishield
• Sputnik V

Saudi Arabia

The General Authority of Civil Aviation of Saudi Arabia has exempted international travellers from the otherwise mandatory seven-day quarantine, if they have taken been vaccinated with:

• Pfizer/BioNTech
• Oxford/AstraZeneca
• Johnson & Johnson
• Moderna

ALSO READ: WHO estimates Covid-19 boosters needed yearly for most vulnerable

This article was first published in Wego.