Spain-made vaccine update: Effective against Omicron and due out this year

A 'HOMEMADE' vaccine against Covid-19 is getting closer to being launched, and is effective against all known current strains of the Coronavirus, according to an update on the eagerly-awaited formula this week.

Set to be a game-changer for a country with very little history of human inoculation development – unlike much more traditional pharmaceutical-industry countries such as Germany and Switzerland – Spain's own Covid jab is being created in a veterinary laboratory.

This makes sense, since the crossover between animal and human medical drugs is considerable; in fact, if you have pets, you may well have been to your local high-street chemist to pick up medications for them.

And Spain's government has been throwing money at the Hipra laboratory in Amer (Girona province), enabling it to focus much more of its time and resources on a Covid vaccine and on reaching meaningful results within a short period.

Using existing jab framework

Some of the spadework for the Spanish Covid immunisation had already been done: Vaccines against viral contagion of varying types start from similar platforms, meaning the research is focused on the specifics; for an adenovirus jab such as the Janssen and AstraZeneca, a deactivated viral particle is introduced into the human organism inside a 'carrier' formula and, as the body cannot tell the difference between a 'live' and a 'dormant' one, it creates 'biological weapons' to fight whichever one it comes up against.

ARN-messenger, or ARNm vaccines, such as the Pfizer and Moderna, use the 'S'-protein or 'spike' of the virus, which 'clings' to the person's system when they are infected for real.

This is where Spain's formula has been able to take advantage of work already carried out: Taking the blueprint for the Pfizer-type vaccine and inserting 'spikes' from more recent mutations of the Coronavirus to generate antibodies, or natural defences, against these.

To date, by using a 'double-S' with a blend of the Alpha and Beta variants of the Covid-causing virus, the Hipra version has shown itself to be effective against the Delta strain.

And now, just what the world has been waiting to hear since around Christmas, the jab is showing 'good results' when faced with the newest Omicron mutation.

Cash helps

One of the reasons for vaccines in general taking so long to develop is merely about notes and coins. If the money pot was bottomless, scientists would be able to get through each essential stage of research and creation without delays, and clinical trials could be run more quickly.

Finance is not, of course, a panacea when it comes to getting the job done. Clinical trials involve a certain necessary length of time to show investigators how far, and for how long, a drug is effective; one which did not produce results that lasted enough time would not, in normal circumstances, reach the shelves due to the high cost of its having to be given again and again to the general public, but with the Covid jab, any protection was considered worth the price as the virus had literally ground life and the world economy to a halt.

Also, scientists have been working around the clock in the race to get the Covid jab fully tested and suitable for approval by international medication authorisation organisms – putting in hours at a pace they would not be able to keep up forever.

Hipra, which has been developing veterinary inoculations for over 50 years and has 39 branches worldwide, has always reinvested 10% of its annual turnover back into research, and Spain's government has handed over another €3 million, whilst the Centre for Industrial Technology Development (CDTI) agreed a further cash injection of €15m in October.

Progress so far

Back in August, Hipra was getting ready to start phase IIb of clinical trials, and received authorisation to go ahead with it from the Spanish Agency for Medications and Healthcare Products (AEMPS), the national answer to the EMA (European Medicines Agency), on November 15.

Barely two months on, they are already analysing the results.

Inital tests on humans, after favourable results from trials on laboratory mice, were aimed purely at checking safety and ensuring side-effects were as mild and bearable as possible – how effective a jab is comes later, since there is no point in a vaccine being a solid shield against Covid and carrying an exceptionally-high risk of heart attacks, cancer, infertility or lifelong chronic pain.

To this end, participants were required to be healthy adults aged from 18 to 39 inclusive, who had not yet had their Covid jab or caught the disease.

After the November authorisation, phase IIb took 1,075 volunteers aged at least 18, who had already had a Pfizer vaccine between six and 12 months ago and who had never had Covid, and gradually got through injecting the whole group via 10 hospitals in Spain, with the last jab given on December 10.

Depending upon the results for each and every one of these volunteers, and assuming they are favourable, phase III of the clinical trials is expected to start in the second half of January.

This time, 3,000 volunteers will be jabbed at 15 hospitals, not just in Spain but also in other European countries.

The reason for the latter is that reactions, tolerability and effectiveness of different pharmaceutical medication can differ very widely between diverse ethnic groups, even those who might appear to be of the same race at first glance.

One extreme example of this has been seen in the over-the-counter painkiller Metamizol, retailed in Spain as Nolotil – no records exist of any native Spaniard having suffered a highly-adverse reaction beyond those they would normally be susceptible to with Ibuprofen, paracetamol and aspirin, but the drug is banned in the UK, Ireland and the USA due to an unacceptably-high percentage of cases of sepsis in users. This very high-profile anomaly seems to show that the Nordic or northern European genotype is much more prone to an allergic reaction to a medication which the Spanish public has been taking for headaches and muscle pains for decades without incidence.

What happens next?

Given how quickly Hipra expects to be able to sign off results from phase IIb – adverse reactions to a virus vaccine, given the very nature of their design, are normally immediate or appear in the short term, rather than appearing gradually years later – it is likely phase III will also be very swift, and clearly, funding this stage is not going to be an issue.

It will take longer, as more volunteers, hospitals and countries are involved, meaning more time needed to inject everyone and to review results, but this is the final stage in vaccine development before a formula is presented for approval for retail.

Scientists are necessarily cautious when predicting dates for this point to be reached, and Hipra is expecting the vaccine to hit the shelves in the second half of 2022.

Then, the only delays involved will be the production process. Manufacturing has been speeded up when it comes to Covid vaccines, as more public funding has been ploughed into taking on the necessary extra hands and purchasing equipment and materials to do so, at a time when a high proportion of much longer-term immunisation research has been parked in order to focus on the immediate health crisis.

Hipra plans to get 600 million doses of its double-jab formula made up, packaged and ready for sale before 2022 is out, and will double this figure, to 1.2 billion, in 2023.

The massive quantity is because Hipra aims to roll out its creation to other parts of the world – countries with less cash to invest in inoculating their population – as well as to other European countries.

Spain's vaccine, given that its development was expected to take longer due to financial issues and a less-evolved pharmaceutical industry, has always been designed with the intention of its being used as a booster rather than an initial vaccine.

But where possible, Hipra has been seeking clinical trials volunteers who have not yet been immunised, to check the formula's effectiveness where no Covid antibodies are present.

How do we know it's effective against newer Covid virus mutations?

Although the 'spikes' used in the double-S jab – a PHH-1V type along similar lines to the Novavax and Sanofi/GSK vaccines, which are expected to be approved for sale shortly – are from two Covid variants, the very first round of 'live' testing found it to be capable of fighting off four mutations.

The Alpha and Beta spikes were introduced into the jab given at first to mice, and the resulting antibodies were found to also neutralise the Gamma and Delta strains.

As Hipra has explained, its vaccine generates 'cell memory' – T-cells, a type of lymphocyte or a white blood cell which is typically found in higher quantities when a person or animal has an infection, remembered what the Alpha and Beta proteins looked like and battled them off. As these T-cells could not tell the difference between these and the Gamma and Delta, both the latter variants proved harmless when attacked by the immune system.

Adapting the jab to fight the much more contagious Omicron variant is a very quick process, and tests to date have shown that the Hipra vaccine heightens the organism's resistance to this strain.